VPA10793/004/001 VPA10793/004/001 Abacare 1% w/v Pour-On Solution Acravet Limited 23/02/2001 VM Unknown AU Pour-on solution QP54AA02 Informed consent application (Article 13c of Directive No 2001/82/EC) Pour-on use Abamectin Prescription Only Medicine Cattle Endectoparasiticides VPA22033/035/001 VPA22033/035/001 Abinex Forte 1 % w/v Pour On Solution Bimeda Animal Health Limited 26/01/2001 VM Unknown AU Pour-on solution QP54AA02 Informed consent application (Article 13c of Directive No 2001/82/EC) Pour-on use Abamectin Prescription Only Medicine Cattle Endectoparasiticides VPA10491/009/001 VPA10491/009/001 Acecare 2 mg/ml Solution for Injection for Dogs and Cats Ecuphar N.V. 15/07/2016 VM Unknown AU Solution for injection QN05AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Acepromazine maleate Prescription Only Medicine Cats Dogs Neurological Preparations VPA10495/004/001 VPA10495/004/001 ACEGON 50 micrograms/ml solution for injection for cattle Laboratorios Syva S.A. 28/02/2014 VM Unknown AU Solution for injection QH01CA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Gonadorelin acetate Prescription Only Medicine Cattle Hormone HOVR10537/018/001 HOVR10537/018/001 Acidum Silicicum Galway Homeopathics (Manufacturing) Limited 08/02/2019 VM AU Oral solution Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC) Oral use Licensed Retailer Cattle Homeopathic VPA22693/024/001 VPA22693/024/001 Acomec 10 mg/ml solution for injection for cattle, sheep and pigs ECO Animal Health Europe Limited 26/11/2004 VM Marketed AU Solution for injection QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA10815/042/001 VPA10815/042/001 Adaxio Shampoo for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Shampoo QD08AC52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Cutaneous use Chlorhexidine digluconate Miconazole nitrate Prescription Only Medicine Dogs Antifungal VPA10980/015/001 VPA10980/015/001 Addimag 160 mg/ml + 84 mg/ml solution for infusion for cattle Alfasan Nederland B.V. 01/04/2022 VM Unknown AU Solution for infusion QA12AX Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Calcium gluconate monohydrate Magnesium chloride hexahydrate Prescription Only Medicine Cattle Vitamins and minerals VPA10980/015/002 VPA10980/015/002 Addimag 240 mg/ml + 126 mg/ml solution for infusion for cattle Alfasan Nederland B.V. 01/04/2022 VM Unknown AU Solution for infusion QA12AX Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intravenous use Calcium gluconate monohydrate Magnesium chloride hexahydrate Prescription Only Medicine Cattle Vitamins and minerals VPA23216/001/001 VPA23216/001/001 Adequan 100 mg/ml Solution for Injection Aniserve GmbH 02/07/2010 VM Unknown AU Solution for injection QM01AX12 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Glycosaminoglycan polysulfate Prescription Only Medicine Horses Miscellaneous VPA10774/063/002 VPA10774/063/002 Aderexa 12.5 mg/125 mg chewable tablets for dogs weighing at least 5 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/063/001 VPA10774/063/001 Aderexa 2.5 mg/25 mg chewable tablets for small dogs and puppies weighing at least 0.5 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA22664/087/001 VPA22664/087/001 Adrenacaine Solution for Injection for Cattle Norbrook Laboratories (Ireland) Limited 17/07/2009 VM Unknown AU Solution for injection QN01BA52 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Procaine hydrochloride Adrenaline tartrate Prescription Only Medicine Cattle Neurological Preparations VPA22020/046/002 VPA22020/046/002 Advantage 100 mg spot-on solution for dogs (≥4 - <10 kg) Elanco GmbH 23/02/2001 VM Marketed AU Spot-on solution QP53AX17 Complete application (stand-alone) - Council Directive 81/851/EEC Spot-on use Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA22020/046/003 VPA22020/046/003 Advantage 250 mg spot-on solution for dogs (≥10 - <25 kg) Elanco GmbH 23/02/2001 VM Marketed AU Spot-on solution QP53AX17 Complete application (stand-alone) - Council Directive 81/851/EEC Spot-on use Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA22020/045/001 VPA22020/045/001 Advantage 40 mg spot-on solution for cats (<4 kg) Elanco GmbH 23/02/2001 VM Marketed AU Spot-on solution QP53AX17 Complete application (stand-alone) - Council Directive 81/851/EEC Cutaneous use Imidacloprid Prescription Only Medicine Cats Ectoparasiticide VPA22020/052/001 VPA22020/052/001 Advantage 40 mg spot-on solution for cats and pet rabbits (<4 kg) Elanco GmbH 24/02/2012 VM Marketed AU Spot-on solution QP53AX17 Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Imidacloprid Prescription Only Medicine Cats Rabbits Ectoparasiticide VPA22020/046/001 VPA22020/046/001 Advantage 40 mg spot-on solution for dogs (<4 kg) Elanco GmbH 23/02/2001 VM Marketed AU Spot-on solution QP53AX17 Complete application (stand-alone) - Council Directive 81/851/EEC Spot-on use Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA22020/047/001 VPA22020/047/001 Advantage 400 mg spot-on solution for dogs (≥25 kg) Elanco GmbH 23/02/2001 VM Marketed AU Spot-on solution QP53AX17 Complete application (stand-alone) - Council Directive 81/851/EEC Spot-on use Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA22020/045/002 VPA22020/045/002 Advantage 80 mg spot-on solution for cats (≥4 kg) Elanco GmbH 23/02/2001 VM Marketed AU Spot-on solution QP53AX17 Complete application (stand-alone) - Council Directive 81/851/EEC Cutaneous use Imidacloprid Prescription Only Medicine Cats Ectoparasiticide VPA22020/052/002 VPA22020/052/002 Advantage 80 mg spot-on solution for cats and pet rabbits (≥4 kg) Elanco GmbH 24/02/2012 VM Marketed AU Spot-on solution QP53AX17 Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Imidacloprid Prescription Only Medicine Cats Rabbits Ectoparasiticide VPA22020/048/003 VPA22020/048/003 Advantix Spot-on solution for dogs over 10 kg up to 25 kg Elanco GmbH 02/04/2004 VM Marketed AU Spot-on solution QP53AC54 Full application (Article 12(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin (Cis:Trans 40:60) Prescription Only Medicine Dogs Ectoparasiticide VPA22020/048/004 VPA22020/048/004 Advantix Spot-on solution for dogs over 25 kg up to 40 kg Elanco GmbH 02/04/2004 VM Marketed AU Spot-on solution QP53AC54 Full application (Article 12(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin (Cis:Trans 40:60) Prescription Only Medicine Dogs Ectoparasiticide VPA22020/048/002 VPA22020/048/002 Advantix Spot-on solution for dogs over 4 kg up to 10 kg. Elanco GmbH 02/04/2004 VM Marketed AU Spot-on solution QP53AC54 Full application (Article 12(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin (Cis:Trans 40:60) Prescription Only Medicine Dogs Ectoparasiticide VPA22020/048/005 VPA22020/048/005 Advantix Spot-on solution for dogs over 40 kg up to 60 kg Elanco GmbH 20/10/2017 VM Unknown AU Spot-on solution QP53AC54 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin (Cis:Trans 40:60) Prescription Only Medicine Dogs Ectoparasiticide VPA22020/048/001 VPA22020/048/001 Advantix Spot-on solution for dogs up to 4 kg Elanco GmbH 02/04/2004 VM Marketed AU Spot-on solution QP53AC54 Full application (Article 12(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin (Cis:Trans 40:60) Prescription Only Medicine Dogs Ectoparasiticide VPA10928/001/001 VPA10928/001/001 Agrisept MC Tabs 2.5 g effervescent tablet for teat dip/spray solution Medentech Ltd. 11/08/2004 VM Not marketed AU Tablet QG52A Complete application (stand-alone) - Council Directive 81/851/EEC Teat use Sodium didichloroioscyanurate (anhydrous) Licensed Retailer Cattle Goats Sheep Antiseptics VPA22664/014/001 VPA22664/014/001 Alamycin Aerosol 3.2 %w/v Cutaneous Spray, solution Norbrook Laboratories (Ireland) Limited 01/10/1988 VM Unknown AU Cutaneous spray, solution QD06AA03 Full application (Article 12(3) of Directive No 2001/82/EC) Cutaneous use Oxytetracycline hydrochloride Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22664/016/001 VPA22664/016/001 Alamycin LA 200 mg/ml Solution for Injection Norbrook Laboratories (Ireland) Limited 01/10/1988 VM Unknown AU Solution for injection QJ01AA06 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Oxytetracycline dihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22664/039/001 VPA22664/039/001 Alamycin LA 300 mg/ml Solution for Injection Norbrook Laboratories (Ireland) Limited 10/02/1994 VM Unknown AU Solution for injection QJ01AA06 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Oxytetracycline dihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10915/006/001 VPA10915/006/001 Albencare with Selenium Oral Suspension Ancare Ireland Ltd. 10/01/1997 VM Unknown AU Oral suspension QP52AC11 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Albendazole Prescription Only Medicine Cattle Endoparasiticide VPA10987/142/002 VPA10987/142/002 Albex 100 mg/ml Oral Suspension Chanelle Pharmaceuticals Manufacturing Limited 22/04/1996 VM Unknown AU Oral suspension QP52AC11 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Albendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10987/142/001 VPA10987/142/001 Albex 25 mg/ml Oral Suspension Chanelle Pharmaceuticals Manufacturing Limited 22/04/1996 VM Unknown AU Oral suspension QP52AC11 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Albendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10987/123/001 VPA10987/123/001 Albex Gold 200 mg/ml oral suspension for cattle Chanelle Pharmaceuticals Manufacturing Limited 19/07/2019 VM Unknown AU Oral suspension QP52AC11 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Albendazole Prescription Only Medicine Cattle Endoparasiticide VPA10782/028/001 VPA10782/028/001 Albiotic 330 mg/100 mg Intramammary Solution Huvepharma NV 31/03/2006 VM Unknown AU Intramammary solution QJ51RF03 Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use Lincomycin hydrochloride Neomycin sulfate Prescription Only Medicine Cattle Antibacterial VPA10792/005/001 VPA10792/005/001 Alcide UDDERgold Platinum CID LINES N.V. 30/04/2008 VM Unknown AU Concentrate for dip solution QG52A Full application (Article 12(3) of Directive No 2001/82/EC) Teat use Sodium chlorite Lactic acid Licensed Retailer Cattle Antiseptics VPA10980/013/001 VPA10980/013/001 Alfacef RTU, 50 mg/ml, suspension for injection for cattle and pigs Alfasan Nederland B.V. 02/03/2012 VM Unknown AU Suspension for injection QJ01DD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Ceftiofur hydrochloride Prescription Only Medicine Cattle Pigs Antibacterial VPA10894/002/001 VPA10894/002/001 Alfacycline LA Solution for Injection Alfa Med Limited 17/02/1995 VM Unknown AU Solution for injection QJ01AA06 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Oxytetracycline dihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10980/019/001 VPA10980/019/001 Alfadexx 2 mg/ml solution for injection for horses, cattle, goats, pigs, dogs and cats Alfasan Nederland B.V. 28/01/2022 VM Unknown AU Solution for injection QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intraarticular use Intramuscular use Intravenous use Periarticular use Subcutaneous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Corticosteroid VPA10980/012/001 VPA10980/012/001 ALFAGLANDIN C 0.250 mg/ml solution for injection for cattle Alfasan Nederland B.V. 29/06/2011 VM Marketed AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cloprostenol sodium Prescription Only Medicine Cattle Hormone VPA10894/004/001 VPA10894/004/001 Alfamox LA 150 mg/ml Suspension for Injection Alfa Med Limited 22/01/1999 VM Unknown AU Suspension for injection QJ01CA04 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Amoxicillin trihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10894/003/001 VPA10894/003/001 Alfapen-Strep Suspension for Injection for Cattle, Sheep and Pigs Alfa Med Limited 23/08/1999 VM Unknown AU Suspension for injection QJ01RA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Benzylpenicillin procaine Dihydrostreptomycin sulphate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10894/005/001 VPA10894/005/001 Alfatrim 40/200 Solution for Injection Alfa Med Limited 12/01/2001 VM Unknown AU Solution for injection QJ01EW10 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Trimethoprim Sulfadiazine Prescription Only Medicine Cattle Pigs Antibacterial VPA10387/103/001 VPA10387/103/001 ALFAXAN 10 mg/ml solution for injection for dogs and cats Zoetis Belgium S.A. 16/05/2008 VM Unknown AU Solution for injection QN01AX05 Full application (Article 12(3) of Directive No 2001/82/EC) Intravenous use Alfaxalone Prescription Only Medicine Cats Dogs Neurological Preparations VPA10387/105/001 VPA10387/105/001 Alfaxan Multidose 10 mg/ml solution for injection for dogs and cats Zoetis Belgium S.A. 07/01/2019 VM AU Solution for injection QN01AX05 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Alfaxalone Prescription Only Medicine Cats Dogs Neurological Preparations VPA10387/104/001 VPA10387/104/001 Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and pet rabbits Zoetis Belgium S.A. 27/04/2018 VM Unknown AU Solution for injection QN01AX05 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intravenous use Alfaxalone Prescription Only Medicine Cats Dogs Rabbits Neurological Preparations VPA10988/066/001 VPA10988/066/001 Alizin 30 mg/ml Solution for Injection Virbac 07/05/2004 VM Unknown AU Solution for injection QG03XB90 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Aglepristone Prescription Only Medicine Dogs Hormone VPA10804/001/001 VPA10804/001/001 ALPHA JECT 3000 Emulsion for injection for Atlantic salmon PHARMAQ AS 01/10/2002 VM Unknown AU Emulsion for injection QI10AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Intraperitoneal use Aeromonas salmonicida subspecies Salmonicida; AL 2017 Listonella anguillarum serotype O1; AL 112 Listonella anguillarum serotype o2a; al 104 Prescription Only Medicine Atlantic salmon Immunological - Inactivated Vaccine VPA10804/003/001 VPA10804/003/001 ALPHA JECT micro 1 PD emulsion for injection for Atlantic salmon PHARMAQ AS 04/12/2015 VM Unknown AU Emulsion for injection QI10AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intraperitoneal use Formaldehyde inactivated culture of salmon pancreas disease virus inactivated strain al v405 Prescription Only Medicine Atlantic salmon Immunological - Inactivated Vaccine VPA10804/005/001 VPA10804/005/001 ALPHA JECT micro 6 emulsion for injection for atlantic salmon PHARMAQ AS 15/03/2019 VM Unknown AU Emulsion for injection QI10AL02 Full application (Article 12(3) of Directive No 2001/82/EC) Intraperitoneal use infectious pancreatic necrosis virus, inactivated Listonella anguillarum serotype o2a; al 104 Listonella anguillarum serotype O1; AL 112 Aeromonas salmonicida subsp. salmonicida, al 2017 Moritella viscosa, al 266 Vibrio salmonicida al 1134 Prescription Only Medicine Atlantic salmon Immunological - Inactivated Vaccine VPA10391/001/001 VPA10391/001/001 Alphalben 100 mg/ml Oral Suspension for Cattle and Sheep Alphavet Zrt. 16/02/2018 VM Unknown AU Oral suspension QP52AC11 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Albendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10980/017/002 VPA10980/017/002 Alpramil 12 mg/30 mg film-coated tablets for cats weighing at least 3 kg Alfasan Nederland B.V. 14/04/2022 VM Unknown AU Film-coated tablet QP54AB51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Milbemycin oxime for veterinary use Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10980/018/002 VPA10980/018/002 Alpramil 12.5 mg/125 mg tablets for dogs weighing at least 5 kg Alfasan Nederland B.V. 14/04/2022 VM Unknown AU Tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime for veterinary use Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10980/017/003 VPA10980/017/003 Alpramil 16 mg/40 mg film-coated tablets for cats weighing at least 4 kg Alfasan Nederland B.V. 14/04/2022 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime for veterinary use Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10980/018/003 VPA10980/018/003 Alpramil 20 mg/200 mg tablets for dogs weighing at least 8 kg Alfasan Nederland B.V. 14/04/2022 VM Unknown AU Tablet QP54AB51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Milbemycin oxime for veterinary use Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10980/017/001 VPA10980/017/001 Alpramil 4 mg/10 mg film-coated tablets for cats weighing at least 0.5 kg Alfasan Nederland B.V. 14/04/2022 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime for veterinary use Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10980/018/001 VPA10980/018/001 Alpramil 5 mg/50 mg tablets for dogs weighing at least 0.5 kg Alfasan Nederland B.V. 14/04/2022 VM Unknown AU Tablet QP54AB51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Milbemycin oxime for veterinary use Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10989/068/001 VPA10989/068/001 Altidox 500 mg/g powder for use in drinking water for pigs, chickens and turkeys Eurovet Animal Health B.V. 21/10/2016 VM Unknown AU Powder for use in drinking water QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycycline hyclate Prescription Only Medicine Chickens Pigs Turkeys Antibacterial VPA10815/010/001 VPA10815/010/001 Altresyn 4 mg/ml oral solution for pigs Ceva Santé Animale 06/02/2009 VM Unknown AU Oral solution QG03DX90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Altrenogest Prescription Only Medicine Pigs Hormone VPA10521/022/001 VPA10521/022/001 Aluspray 4% w/w Cutaneous Spray, Powder Vetoquinol S.A. 01/10/1989 VM Unknown AU Cutaneous spray, powder QD08AB Full application (Article 12(3) of Directive No 2001/82/EC) Cutaneous use Aluminium Licensed Retailer Cats Cattle Chickens Dogs Horses Pigs Sheep Antiseptics VPA16142/003/001 VPA16142/003/001 Alvebuton 100 mg/ml Solution for injection for cattle, pigs, horses, sheep, goats V.M.D. n.v., 24/03/2017 VM Not marketed AU Solution for injection QA05AX90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Menbutone Prescription Only Medicine Cattle Goats Horses Pigs Sheep Alimentary Tract Preparation VPA16142/002/001 VPA16142/002/001 Alvegesic vet. 10 mg/ml Solution for injection for Horses, Dogs and Cats V.M.D. n.v., 04/09/2009 VM Marketed AU Solution for injection QN02AF01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Butorphanol tartrate Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA10495/001/001 VPA10495/001/001 Alzane 5 mg/ml, solution for injection for dogs and cats Laboratorios Syva S.A. 28/10/2011 VM Unknown AU Solution for injection QV03AB90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Atipamezole hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10774/045/001 VPA10774/045/001 Amatib 800 mg/g oral powder for pigs and chickens Krka, d.d., Novo mesto 21/08/2015 VM Not marketed AU Powder for use in drinking water QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate Prescription Only Medicine Chickens Pigs Antibacterial VPA10774/059/002 VPA10774/059/002 Amcofen 12.5/125.0 mg chewable tablets for dogs weighing at least 5 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/059/004 VPA10774/059/004 Amcofen 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 kg Krka, d.d., Novo mesto 17/09/2021 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/060/002 VPA10774/060/002 Amcofen 16 mg/40 mg chewable tablets for cats weighing at least 2 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10774/059/001 VPA10774/059/001 Amcofen 2.5 mg/25 mg chewable tablets for small dogs and puppies weighing at least 0.5 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/059/003 VPA10774/059/003 Amcofen 2.5 mg/25 mg film-coated tablets for small dogs and puppies weighing at least 0.5 kg Krka, d.d., Novo mesto 17/09/2021 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/060/001 VPA10774/060/001 Amcofen 4 mg/10 mg chewable tablets for small cats and kittens weighing at least 0.5 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10774/022/001 VPA10774/022/001 Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs Krka, d.d., Novo mesto 22/02/2013 VM Unknown AU Cutaneous spray, solution QP53AX15 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Cutaneous use Fipronil Prescription Only Medicine Cats Dogs Ectoparasiticide VPA10774/051/002 VPA10774/051/002 Amflee Combo 134 mg/120.6 mg spot-on solution for medium dogs Krka, d.d., Novo mesto 06/07/2018 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Dogs Ectoparasiticide VPA10774/051/003 VPA10774/051/003 Amflee Combo 268 mg/241.2 mg spot-on solution for large dogs Krka, d.d., Novo mesto 06/07/2018 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Dogs Ectoparasiticide VPA10774/051/004 VPA10774/051/004 Amflee Combo 402 mg/361.8 mg spot-on solution for extra large dogs Krka, d.d., Novo mesto 06/07/2018 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Dogs Ectoparasiticide VPA10774/050/001 VPA10774/050/001 Amflee Combo 50 mg/60 mg spot-on solution for cats Krka, d.d., Novo mesto 06/07/2018 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Cats Ectoparasiticide VPA10774/051/001 VPA10774/051/001 Amflee Combo 67 mg/60.3 mg spot-on solution for small dogs Krka, d.d., Novo mesto 06/07/2018 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Dogs Ectoparasiticide VPA10815/048/001 VPA10815/048/001 Amodip 1.25 mg chewable tablets for cats Ceva Santé Animale 23/12/2016 VM Unknown AU Chewable tablet QC08CA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Amlodipine Prescription Only Medicine Cats Cardiovascular VPA10475/013/002 VPA10475/013/002 Amoxibactin 250 mg tablets for dogs Le Vet Beheer B.V. 16/01/2015 VM Unknown AU Tablet QJ01CA04 Not Currently Available Oral use Amoxicillin Prescription Only Medicine Dogs Antibacterial VPA10475/013/001 VPA10475/013/001 Amoxibactin 50 mg tablets for dogs and cats Le Vet Beheer B.V. 16/01/2015 VM Unknown AU Tablet QJ01CA04 Not Currently Available Oral use Amoxicillin Prescription Only Medicine Cats Dogs Antibacterial VPA10475/013/003 VPA10475/013/003 Amoxibactin 500 mg tablets for dogs Le Vet Beheer B.V. 16/01/2015 VM Unknown AU Tablet QJ01CA04 Not Currently Available Oral use Amoxicillin Prescription Only Medicine Dogs Antibacterial VPA10477/002/001 VPA10477/002/001 AMOXICILLIN GLOBAL VET HEALTH 500 mg/g, powder for use in drinking water for chickens, turkeys, ducks and pigs GLOBAL VET HEALTH SL 04/12/2015 VM Unknown AU Powder for use in drinking water QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Oral use Amoxicillin trihydrate Prescription Only Medicine Chickens Duck Pigs Turkeys Antibacterial VPA10983/041/001 VPA10983/041/001 Amoxinsol 50 % w/w powder for oral solution Vetoquinol Ireland Limited 11/07/1995 VM Unknown AU Powder for oral solution QJ01CA04 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Amoxicillin Prescription Only Medicine Chickens Duck Pigs Turkeys Antibacterial VPA10791/005/001 VPA10791/005/001 AMOXY ACTIVE, 697 mg/g, oral powder for pigs and chickens Dopharma Research B.V. 22/08/2014 VM Marketed AU Oral powder QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin Prescription Only Medicine Chickens Pigs Antibacterial VPA10782/034/001 VPA10782/034/001 Amphen 200 mg/g granules for use in drinking water for pigs Huvepharma NV 29/11/2019 VM AU Granules for use in drinking water QJ01BA90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Florfenicol Prescription Only Medicine Pigs Antibacterial VPA10782/044/001 VPA10782/044/001 Amphen 200 mg/ml suspension for use in drinking water for pigs Huvepharma NV 12/01/2024 VM Unknown AU Suspension for use in drinking water QJ01BA90 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Drinking Water Florfenicol Prescription Only Medicine Pigs Antibacterial VPA10793/002/001 VPA10793/002/001 Ampisol 2g, powder for solution for injection Acravet Limited 18/12/1991 VM Unknown AU Powder for solution for injection QJ01CA01 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Intravenous use Ampicillin sodium Prescription Only Medicine Horses Antibacterial VPA10453/002/001 VPA10453/002/001 AMPROLINE 400 mg/mL solution for use in drinking water for chickens and turkeys HUVEPHARMA SA 30/08/2019 VM Unknown AU Solution for use in drinking water QP51AX09 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Amprolium hydrochloride Prescription Only Medicine Chickens Turkeys Coccidiostats VPA10804/002/001 VPA10804/002/001 AMX 10 mg/ml concentrate for solution for fish treatment PHARMAQ AS 06/02/2009 VM Unknown AU Concentrate for solution for fish treatment QP53AC11 Full application (Article 12(3) of Directive No 2001/82/EC) Topical use Water-borne use Deltamethrin Prescription Only Medicine Atlantic salmon Trout Ectoparasiticide VPA10900/010/001 VPA10900/010/001 Anaemex 200 mg/ml Solution for Injection Ark Animal Care Ltd., 01/10/1989 VM AU Solution for injection QB03AC90 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramuscular use Iron dextran Licensed Retailer Pigs Vitamins and minerals VPA10475/010/001 VPA10475/010/001 Anaestamine 100 mg/ml solution for injection Le Vet Beheer B.V. 14/11/2014 VM Unknown AU Solution for injection QN01AX03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Ketamine hydrochloride Prescription Only Medicine Cats Cattle Dogs Goats Guinea pig Hamster Horses Pigs Rabbits Sheep Neurological Preparations VPA10810/025/001 VPA10810/025/001 Analeptol 50 mg/ml + 50 mg/ml solution for injection for cattle, horses, pigs, dogs and cats CP-Pharma Handelsgesellschaft mbH 07/07/2023 VM *** AWAITING VALUE *** AU Solution for injection QR03DA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intraperitoneal use Intravenous use Heptaminol hydrochloride Diprophylline Prescription Only Medicine Cats Cattle Dogs Horses Pigs Cardiovascular VPA10987/070/001 VPA10987/070/001 Animec 0.8 mg/ml Oral Solution for Sheep Chanelle Pharmaceuticals Manufacturing Limited 29/05/2009 VM Unknown AU Oral solution QP54AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA10987/147/001 VPA10987/147/001 Animec 1 % Solution for Injection Chanelle Pharmaceuticals Manufacturing Limited 12/01/2001 VM Unknown AU Solution for injection QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA25460/001/001 VPA25460/001/001 Animec 18.7 mg/g Oral Paste for Horses Acme Drugs S.r.l. 10/11/2006 VM Unknown AU Oral paste QP54AA01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Horses Endectoparasiticides VPA10987/152/001 VPA10987/152/001 Animec 5 mg/ml Pour-on Solution for Cattle Chanelle Pharmaceuticals Manufacturing Limited 03/12/2004 VM Unknown AU Pour-on solution QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/068/001 VPA10987/068/001 Animec Super Solution for Injection Chanelle Pharmaceuticals Manufacturing Limited 25/06/2010 VM Unknown AU Solution for injection QP54AA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Clorsulon Prescription Only Medicine Cattle Endectoparasiticides VPA10826/005/001 VPA10826/005/001 Animedazon Spray, 2.45 % w/w cutaneous spray suspension for cattle, sheep and pigs aniMedica GmbH 24/10/2008 VM Marketed AU Cutaneous spray, suspension QD06AA02 Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Chlortetracycline hydrochloride Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10826/025/001 VPA10826/025/001 Animeloxan, 20 mg/ml, solution for injection for cattle, pigs and horses aniMedica GmbH 24/05/2019 VM Unknown AU Solution for injection QM01AC06 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Meloxicam Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10987/158/001 VPA10987/158/001 Anisec 0.5 % w/v Pour-on Solution Chanelle Pharmaceuticals Manufacturing Limited 13/05/2005 VM Not marketed AU Pour-on solution QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10774/049/001 VPA10774/049/001 Anthelmin 230 mg/20 mg film-coated tablets for cats Krka, d.d., Novo mesto 31/03/2017 VM Unknown AU Film-coated tablet QP52AA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pyrantel embonate Praziquantel Companion Animal Medicine Cats Endoparasiticide VPA10774/033/001 VPA10774/033/001 Anthelmin Plus Flavour Tablets for dogs Krka, d.d., Novo mesto 01/05/2015 VM Unknown AU Tablet QP52AC55 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA10774/033/002 VPA10774/033/002 Anthelmin Plus XL Tablets for dogs Krka, d.d., Novo mesto 01/05/2015 VM Unknown AU Tablet QP52AC55 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA10664/003/001 VPA10664/003/001 Antisedan 5 mg/ml solution for injection Orion Corporation 26/02/2010 VM Unknown AU Solution for injection QV03AB90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Atipamezole hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations HOVR23152/001/001 HOVR23152/001/001 Anxt-F HomeoPet Pet Products Limited 20/01/2012 VM Unknown AU Oral solution Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC) Oral use Aconite (aconitum napellus) Avena sativa Belladonna (atropa belladonna) Borax (natrium tetraboracicum) Calcium phosphoricum Gelsemium sempervirens Lycopodium clavatum Natrium carbonicum Natrium chloratum (natrium mur) Passiflora incarnata Phosphorus Rhododendron Scutellaria lateriflora Silicea (acidum silicicum) Staphisagria (delphinium) Stramonium (datura stramonium) Valeriana officinalis Aconite (aconitum napellus) Avena sativa Borax (natrium tetraboracicum) Calcium phosphoricum Gelsemium sempervirens Gelsemium sempervirens Lycopodium clavatum Natrium carbonicum Passiflora incarnata Phosphorus Phosphorus Phosphorus Scutellaria lateriflora Valeriana officinalis Silicea (acidum silicicum) Staphisagria (delphinium) Companion Animal Medicine Cats Dogs Ornamental birds Homeopathic VPA10388/001/001 VPA10388/001/001 Api-Bioxal 0.71 g/g bee-hive powder Chemicals Laif S.P.A 07/04/2017 VM Unknown AU Powder for bee-hive solution QP53AG03 Full application (Article 12(3) of Directive No 2001/82/EC) In-hive use Oxalic acid dihydrate Licensed Retailer Honey bees Ectoparasiticide VPA10388/001/002 VPA10388/001/002 API-Bioxal 44.2 mg/ml bee-hive solution Chemicals Laif S.P.A 10/12/2021 VM Unknown AU Bee-hive solution QP53AG03 Well-established use application (Article 13a of Directive No 2001/82/EC) In-hive use Oxalic acid Licensed Retailer Honey bees Ectoparasiticide VPA22752/001/001 VPA22752/001/001 APIGUARD gel 12.5 g for beehive use Vita Bee Health Limited 21/03/2003 VM Unknown AU Gel QP53AX22 Not Currently Available In-hive use Thymol Licensed Retailer Honey bees Ectoparasiticide VPA22752/001/002 VPA22752/001/002 APIGUARD MULTIDOSE 0.25 g/g bee-hive gel Vita Bee Health Limited 13/05/2022 VM Unknown AU Bee-hive gel QP53AX22 Full application (Article 12(3) of Directive No 2001/82/EC) In-hive use Thymol Licensed Retailer Honey bees Ectoparasiticide VPA22827/001/001 VPA22827/001/001 Apivar 500 mg bee-hive strips for honey bees Veto-Pharma 26/09/2017 VM Unknown AU Bee-hive strip QP53AD01 Well-established use application (Article 13a of Directive No 2001/82/EC) In-hive use Amitraz Licensed Retailer Honey bees Ectoparasiticide PVPA10400/001/001 PVPA10400/001/001 Apivar 500 mg Bee-hive strips for honey bees Duggan Veterinary Supplies Limited 24/07/2020 VM Unknown AU Bee-hive strip QP53AD01 Well-established use application (Article 13a of Directive No 2001/82/EC) In-hive use Amitraz Licensed Retailer Honey bees Ectoparasiticide VPA22622/002/002 VPA22622/002/002 Apovomin 1 mg/ml solution for injection for dogs Dechra Regulatory B.V. 16/04/2021 VM Unknown AU Solution for injection QN04BC07 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Apomorphine hydrochloride hemihydrate Prescription Only Medicine Dogs Neurological Preparations VPA22622/002/001 VPA22622/002/001 Apovomin 3 mg/ml solution for injection for dogs Dechra Regulatory B.V. 16/03/2018 VM Unknown AU Solution for injection QN04BC07 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Apomorphine hydrochloride hemihydrate Prescription Only Medicine Dogs Neurological Preparations VPA10782/013/001 VPA10782/013/001 Apravet 100 g/kg premix for medicated feeding stuff for pigs Huvepharma NV 29/08/2013 VM Unknown AU Premix for medicated feeding stuff QJ01GB Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Apramycin sulphate Prescription Only Medicine Pigs Antibacterial VPA10782/024/001 VPA10782/024/001 Apravet 552 IU/mg powder for use in drinking water/milk for pigs, calves, chickens and rabbits Huvepharma NV 14/09/2018 VM Unknown AU Powder for use in drinking water/milk QA07AA92 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water/milk use Apramycin Prescription Only Medicine Cattle Chickens Pigs Rabbits Antibacterial VPA10990/024/001 VPA10990/024/001 Aquaprim Solution for Injection Univet Limited 01/10/1988 VM Unknown AU Solution for injection QJ01EW10 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Sulfadiazine Trimethoprim Prescription Only Medicine Cattle Pigs Antibacterial VPA10996/214/001 VPA10996/214/001 AquaVac ERM. Concentrate for dip suspension for Rainbow trout Intervet Ireland Limited 22/10/2010 VM Unknown AU Concentrate for dip suspension QI10BB03 Full application (Article 12(3) of Directive No 2001/82/EC) Dipping Yersinia ruckeri cells inactivated (Hagerman type 1 stain) Prescription Only Medicine Trout Immunological - Inactivated Vaccine VPA10996/274/001 VPA10996/274/001 AquaVac PD3 emulsion for injection for Atlantic salmon Intervet Ireland Limited 27/03/2015 VM Unknown AU Emulsion for injection QI10AL Full application (Article 12(3) of Directive No 2001/82/EC) Intraperitoneal use Inactivated salmon pancreas disease virus Inactivated infectious pancreatic necrosis virus Inactivated aeromonas salmonicida subsp. salmonicida Prescription Only Medicine Atlantic salmon Immunological - Inactivated Vaccine VPA10996/290/001 VPA10996/290/001 AquaVac S7 emulsion for injection for Atlantic salmon Intervet Ireland Limited 20/03/2026 VM Unknown AU Emulsion for injection QI10AL Full application (Article 8 of Regulation (EU) 2019/6) Intraperitoneal use Infectious pancreatic necrosis virus, serotype Sp, strain SP.2005.009, Inactivated Aeromonas salmonicida, subsp. salmonicida, strain FT 449, Inactivated Aliivibrio salmonicida, strain NCMB 2262, Inactivated Vibrio anguillarum, serotype O1, strain FT 257, Inactivated Vibrio anguillarum, serotype O2a, strain FT 256, Inactivated Moritella viscosa, strain RO 1.0, Inactivated Yersinia ruckeri, serotype O1, biotype 1, strain Hagerman, Inactivated Prescription Only Medicine Atlantic salmon Immunological - Inactivated Vaccine VPA10491/010/001 VPA10491/010/001 Aqupharm 1 (9 mg/ml) solution for injection/infusion Ecuphar N.V. 11/11/2016 VM Unknown AU Solution for injection/infusion QB05BB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intraperitoneal use Intravenous use Subcutaneous use Sodium chloride Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Rabbits Sheep Electrolytes VPA10491/011/001 VPA10491/011/001 Aqupharm 11 (Hartmann's) Solution for Infusion Ecuphar N.V. 16/12/2016 VM Unknown AU Solution for injection/infusion QB05BB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Sodium lactate Calcium chloride dihydrate Potassium chloride Sodium chloride Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Rabbits Sheep Electrolytes VPA10990/050/001 VPA10990/050/001 Arentor DC 250 mg Intramammary Suspension for Dry Cows Univet Limited 07/12/2018 VM AU Intramammary suspension QJ51DB90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Cefalonium dihydrate Prescription Only Medicine Cattle Antibacterial VPA10509/008/002 VPA10509/008/002 ARIXIL vet 20 mg film-coated tablet for dogs Industrial Veterinaria S.A. 05/04/2019 VM AU Film-coated tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Dogs Cardiovascular VPA10509/008/001 VPA10509/008/001 ARIXIL vet 5 mg film-coated tablet for dogs and cats Industrial Veterinaria S.A. 05/04/2019 VM AU Film-coated tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Cats Dogs Cardiovascular VPA10915/003/001 VPA10915/003/001 Arrest Oral Suspension Ancare Ireland Ltd. 26/01/2001 VM Unknown AU Oral suspension QP52AC13 QP52AE01 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Fenbendazole Levamisole hydrochloride Prescription Only Medicine Sheep Endoparasiticide VPA25433/002/001 VPA25433/002/001 ASHIDOX 500 mg/g, powder for use in drinking water/milk for cattle (pre-ruminant), pigs and chickens Ashish Life Science Holding B.V. 13/06/2025 VM Unknown AU Powder for use in drinking water/milk QJ01AA02 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Doxycycline hyclate Prescription Only Medicine Cattle Chickens Pigs Antibacterial VPA10774/034/003 VPA10774/034/003 Ataxxa 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg Krka, d.d., Novo mesto 30/10/2015 VM Not marketed AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA10774/034/001 VPA10774/034/001 Ataxxa 200 mg/40 mg spot-on solution for dogs up to 4 kg Krka, d.d., Novo mesto 30/10/2015 VM Not marketed AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA10774/034/004 VPA10774/034/004 Ataxxa 2000 mg/400 mg spot-on solution for dogs over 25 kg Krka, d.d., Novo mesto 30/10/2015 VM Not marketed AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA10774/034/002 VPA10774/034/002 Ataxxa 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg Krka, d.d., Novo mesto 30/10/2015 VM Not marketed AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA10989/055/001 VPA10989/055/001 Atipam, 5.0 mg/ml, solution for injection for cats and dogs Eurovet Animal Health B.V. 23/05/2008 VM Unknown AU Solution for injection QV03AB90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Atipamezole hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA22020/016/001 VPA22020/016/001 Atopica 10 mg soft capsules for dogs Elanco GmbH 17/06/2016 VM Unknown AU Capsule, soft QL04AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Ciclosporin Prescription Only Medicine Dogs Miscellaneous VPA22020/013/001 VPA22020/013/001 Atopica 100 mg/ml oral solution for cats and dogs Elanco GmbH 06/01/2017 VM Unknown AU Oral solution QL04A Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Ciclosporin Prescription Only Medicine Cats Dogs Miscellaneous VPA22020/016/004 VPA22020/016/004 Atopica 100 mg soft capsules for dogs Elanco GmbH 17/06/2016 VM Unknown AU Capsule, soft QL04AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Ciclosporin Prescription Only Medicine Dogs Miscellaneous VPA22020/016/002 VPA22020/016/002 Atopica 25 mg soft capsules for dogs Elanco GmbH 17/06/2016 VM Unknown AU Capsule, soft QL04AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Ciclosporin Prescription Only Medicine Dogs Miscellaneous VPA22020/016/003 VPA22020/016/003 Atopica 50 mg soft capsules for dogs Elanco GmbH 17/06/2016 VM Unknown AU Capsule, soft QL04AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Ciclosporin Prescription Only Medicine Dogs Miscellaneous VPA23462/005/001 VPA23462/005/001 Aurimic ear drops and cutaneous suspension for dogs and cats VetViva Richter GmbH 13/03/2015 VM Unknown AU Ear drops, suspension QS02CA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Auricular use Cutaneous use Miconazole nitrate Prednisolone acetate Polymyxin b sulfate Prescription Only Medicine Cats Dogs Antibacterial VPA10521/027/001 VPA10521/027/001 AURIZON ear drops, suspension Vetoquinol S.A. 02/11/2001 VM Unknown AU Ear drops, suspension QS02CA06 Not Currently Available Auricular use Marbofloxacin Clotrimazole Dexamethasone acetate Prescription Only Medicine Dogs Antibacterial VPA25497/001/001 VPA25497/001/001 Aurofac Granular 250 mg/g Premix for medicated feedingstuff for pigs and chickens Phibro Animal Health (Poland) Sp. z o.o. 09/12/2013 VM Unknown AU Premix for medicated feeding stuff QJ01AA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Chlortetracycline hydrochloride Prescription Only Medicine Chickens Pigs Antibacterial VPA10987/065/001 VPA10987/065/001 Austiofen 20 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 02/06/2006 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10454/027/001 VPA10454/027/001 AVINEW NEO effervescent tablet for chickens and turkeys Boehringer Ingelheim Vetmedica GmbH 13/11/2015 VM Unknown AU Effervescent tablet QI01AD06 Full application (Article 12(3) of Directive No 2001/82/EC) Ocular use Oculonasal use Oral use Live newcastle disease virus (VG/GA) component Prescription Only Medicine Chickens Turkeys Immunological - Live Vaccine VPA22020/068/001 VPA22020/068/001 AviPro Thymovac Lyophilisate for use in drinking water Elanco GmbH 12/12/2008 VM Unknown AU Oral lyophilisate QI01AD04 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Live chicken anaemia virus (CAV), strain cux-1 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA25579/004/001 VPA25579/004/001 Avishield IB GI-13, lyophilisate for oculonasal suspension/use in drinking water for chickens Izo S.r.l. 29/05/2020 VM Unknown AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD07 Full application (Article 12(3) of Directive No 2001/82/EC) In drinking water use Oculonasal use Oral use Avian infectious bronchitis virus, live Prescription Only Medicine Chickens Immunological - Live Vaccine VPA25579/001/001 VPA25579/001/001 Avishield IB H120, lyophilisate for oculonasal suspension/use in drinking water, for chickens Izo S.r.l. 09/02/2018 VM Not marketed AU Lyophilisate for suspension for oculonasal or spray app QI01AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Oculonasal use Oral use Avian infectious brochitis virus massachusetts serotype strain h-120 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA25579/006/001 VPA25579/006/001 Avishield IB QX Izo S.r.l. 13/06/2025 VM Unknown AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD07 Full application - new active substance (Article 8 of Regulation (EU) 2019/6) In drinking water use Oculonasal use Avian infectious bronchitis virus, type QX, strain 1285, Live Prescription Only Medicine Chickens Immunological - Live Vaccine VPA25579/003/001 VPA25579/003/001 Avishield IBD INT, lyophilisate for oculonasal suspension/use in drinking water, for chickens Izo S.r.l. 07/01/2019 VM AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) Oculonasal use Oral use Avian infectious bursal disease virus, live Prescription Only Medicine Chickens Immunological - Live Vaccine VPA25579/005/001 VPA25579/005/001 Avishield IBD Plus, lyophilisate for use in drinking water, for chickens Izo S.r.l. 26/06/2020 VM Unknown AU Lyophilisate for use in drinking water QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) In drinking water use Avian infectious bursal disease virus, live Prescription Only Medicine Chickens Immunological - Live Vaccine VPA25579/002/001 VPA25579/002/001 Avishield ND B1, lyophilisate for oculonasal suspension/use in drinking water for chickens. Izo S.r.l. 18/05/2018 VM Not marketed AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD06 Full application (Article 12(3) of Directive No 2001/82/EC) Oculonasal use Oral use Newcastle disease virus, live Prescription Only Medicine Chickens Immunological - Live Vaccine VPA1136/002/001 VPA1136/002/001 Azaporc 40 mg/ml solution for injection for pigs Serumwerk Bernburg AG 05/03/2021 VM Unknown AU Solution for injection QN05AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Azaperone Prescription Only Medicine Pigs Neurological Preparations VPA10465/003/001 VPA10465/003/001 B. Braun Vet Care Hartmann's Lactated Ringers Solution for infusion for cattle, horses, sheep, goats, pigs, dogs and cats B. Braun Melsungen AG. 17/08/2012 VM Marketed AU Solution for infusion QB05BB01 Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Sodium chloride Potassium chloride Calcium chloride dihydrate Sodium lactate Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Sheep Electrolytes VPA10956/007/001 VPA10956/007/001 B.V.P. COPPER WITH VITAMIN B12 INJECTION Ballinskelligs Vet. Products Ltd 01/10/1991 VM Not marketed AU Suspension for injection QA12CX Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Copper methionate Vitamin B12 Prescription Only Medicine Cattle Sheep Vitamins and minerals VPA10956/007/002 VPA10956/007/002 B.V.P. COPPER WITH VITAMIN B12 INJECTION Ballinskelligs Vet. Products Ltd 01/10/1991 VM Not marketed AU Suspension for injection QA12CX Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Copper methionate Vitamin B12 Licensed Retailer Cattle Sheep Vitamins and minerals VPA10521/018/001 VPA10521/018/001 Bactidiaryl Oral Powder Vetoquinol S.A. 01/10/1988 VM Unknown AU Oral powder QJ01RA90 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Neomycin sulfate Tetracycline hydrochloride Prescription Only Medicine Cattle Antibacterial VPA10665/011/002 VPA10665/011/002 Banacep Vet 20 mg film-coated tablets for dogs LABORATORIOS CALIER S.A. 17/10/2025 VM Unknown AU Film-coated tablet QC09AA07 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Benazepril hydrochloride Prescription Only Medicine Dogs Cardiovascular VPA10665/011/001 VPA10665/011/001 Banacep Vet 5 mg film-coated tablets for dogs and cats LABORATORIOS CALIER S.A. 17/10/2025 VM Unknown AU Film-coated tablet QC09AA07 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Benazepril hydrochloride Prescription Only Medicine Cats Dogs Cardiovascular VPA22020/054/001 VPA22020/054/001 Baycox 25 mg/ml, solution for use in drinking water for chickens and turkeys Elanco GmbH 15/08/2014 VM Not marketed AU Solution for use in drinking water QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Chickens Turkeys Coccidiostats VPA22020/055/001 VPA22020/055/001 Baycox Multi 50 mg/ml oral suspension for Cattle, Pigs and Sheep Elanco GmbH 25/11/2016 VM Unknown AU Oral suspension QP51BC01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Cattle Pigs Sheep Coccidiostats VPA10521/013/001 VPA10521/013/001 Bayer Dog Tasty Bone 150/144/50 mg tablets Vetoquinol SA 24/10/2014 VM Unknown AU Tablet QP52AC55 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA10521/013/002 VPA10521/013/002 Bayer Dog Tasty Bone XL 525/504/175 mg tablets Vetoquinol SA 08/09/2017 VM Unknown AU Tablet QP52AA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA22020/060/001 VPA22020/060/001 Bayticol 10 mg/ml Pour-On Solution Elanco GmbH 01/10/1989 VM Marketed AU Pour-on solution QP53AC05 Full application (Article 12(3) of Directive No 2001/82/EC) Pour-on use Flumethrin Prescription Only Medicine Cattle Ectoparasiticide VPA22020/043/001 VPA22020/043/001 Baytril 100 mg/ml Solution for Injection Elanco GmbH 01/10/1988 VM Marketed AU Solution for injection QJ01MA90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Goats Pigs Sheep Antibacterial VPA22020/063/001 VPA22020/063/001 Baytril 100 mg/ml solution for use in drinking water for chickens, turkeys and rabbits Elanco GmbH 01/10/1988 VM Marketed AU Oral solution QJ01MA90 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Chickens Rabbits Turkeys Antibacterial VPA22020/062/001 VPA22020/062/001 Baytril 25 mg/ml Oral Solution Elanco GmbH 01/10/1988 VM Marketed AU Oral solution QJ01MA90 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Cattle Chinchilla Gerbil Guinea pig Hamster Mouse Ornamental birds Rat Reptiles Antibacterial VPA22020/044/001 VPA22020/044/001 Baytril 25 mg/ml solution for injection Elanco GmbH 01/10/1988 VM Marketed AU Solution for injection QJ01MA90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cats Chinchilla Dogs Gerbil Guinea pig Hamster Mouse Ornamental birds Pigs Rabbits Rat Reptiles Antibacterial VPA22020/061/001 VPA22020/061/001 Baytril 50 mg/ml Solution for Injection Elanco GmbH 01/10/1988 VM Marketed AU Solution for injection QJ01MA90 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cats Cattle Dogs Goats Pigs Sheep Antibacterial VPA22020/065/001 VPA22020/065/001 Baytril Flavour Tablets 15 mg Elanco GmbH 01/10/1988 VM Marketed AU Tablet QJ01MA90 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Enrofloxacin Prescription Only Medicine Cats Dogs Antibacterial VPA22020/065/003 VPA22020/065/003 Baytril Flavour Tablets 150 mg Elanco GmbH 01/10/1988 VM Marketed AU Tablet QJ01MA90 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Enrofloxacin Prescription Only Medicine Dogs Antibacterial VPA22020/065/002 VPA22020/065/002 Baytril Flavour Tablets 50 mg Elanco GmbH 01/10/1988 VM Marketed AU Tablet QJ01MA90 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Enrofloxacin Prescription Only Medicine Dogs Antibacterial VPA22020/053/001 VPA22020/053/001 Baytril Max 100 mg/ml Solution for Injection for Cattle and Pigs Elanco GmbH 23/11/2012 VM Marketed AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10455/004/001 VPA10455/004/001 Beaphar Insecticidal Dog Shampoo, 0.2% w/w Beaphar B.V. 01/10/1989 VM AU Shampoo QP53AC04 Full application (Article 12(3) of Directive No 2001/82/EC) Cutaneous use Permethrin (Cis:Trans 40:60) Companion Animal Medicine Dogs Ectoparasiticide VPA10455/005/001 VPA10455/005/001 Beaphar Pump Action Flea Spray, Cutaneous Spray Solution Beaphar B.V. 01/10/1989 VM AU Cutaneous spray, solution QP53AC51 Full application (Article 12(3) of Directive No 2001/82/EC) Cutaneous use 25% Pyrethrum extract Piperonyl butoxide Companion Animal Medicine Cats Dogs Ectoparasiticide VPA22622/046/002 VPA22622/046/002 Benakor 20 mg tablets for dogs Dechra Regulatory B.V. 24/10/2008 VM Unknown AU Tablet QC09AA07 Not Currently Available Oral use Benazepril hydrochloride Prescription Only Medicine Dogs Cardiovascular VPA22622/046/001 VPA22622/046/001 Benakor 5 mg tablets for dogs Dechra Regulatory B.V. 24/10/2008 VM Unknown AU Tablet QC09AA07 Not Currently Available Oral use Benazepril hydrochloride Prescription Only Medicine Dogs Cardiovascular VPA10988/119/001 VPA10988/119/001 Benamix 6.25 mg/g premix for medicated feeding stuff for cats. Virbac 28/03/2025 VM Unknown AU Premix for medicated feeding stuff QC09AA07 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Benazepril hydrochloride Prescription Only Medicine Cats Cardiovascular VPA10491/006/002 VPA10491/006/002 Benazecare Flavour 20 mg Tablets for Dogs Ecuphar N.V. 24/08/2006 VM Unknown AU Tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Dogs Cardiovascular VPA10491/006/001 VPA10491/006/001 Benazecare Flavour 5 mg Tablets for Dogs and Cats Ecuphar N.V. 24/08/2006 VM Unknown AU Tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Cats Dogs Cardiovascular VPA10482/001/001 VPA10482/001/001 Benefortin Flavour 2.5 mg tablets for cats and dogs LAVET Pharmaceuticals Ltd 27/01/2012 VM Marketed AU Tablet QC09AA07 Not Currently Available Oral use Benazepril hydrochloride Prescription Only Medicine Cats Dogs Cardiovascular VPA10482/001/003 VPA10482/001/003 Benefortin Flavour 20 mg tablets for dogs LAVET Pharmaceuticals Ltd 27/01/2012 VM Marketed AU Tablet QC09AA07 Not Currently Available Oral use Benazepril hydrochloride Prescription Only Medicine Cats Dogs Cardiovascular VPA10482/001/002 VPA10482/001/002 Benefortin Flavour 5 mg tablets for cats and dogs LAVET Pharmaceuticals Ltd 27/01/2012 VM Marketed AU Tablet QC09AA07 Not Currently Available Oral use Benazepril hydrochloride Prescription Only Medicine Cats Dogs Cardiovascular VPA22664/129/001 VPA22664/129/001 Betafuse 1 mg/g + 5 mg/g gel for dogs Norbrook Laboratories (Ireland) Limited 16/09/2016 VM Unknown AU Gel QD07CC01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Cutaneous use Betamethasone valerate Fusidic acid hemihydrate Prescription Only Medicine Dogs Antibacterial VPA22664/004/001 VPA22664/004/001 Betamox 150 mg/ml Suspension for Injection Norbrook Laboratories (Ireland) Limited 01/10/1987 VM Unknown AU Suspension for injection QJ01CA04 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Amoxicillin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22664/010/001 VPA22664/010/001 Betamox LA 150 mg/ml Suspension for Injection Norbrook Laboratories (Ireland) Limited 01/10/1987 VM Unknown AU Suspension for injection QJ01CA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Amoxicillin Prescription Only Medicine Cats Cattle Dogs Pigs Sheep Antibacterial VPA10987/074/001 VPA10987/074/001 Bexepril 2.5 mg Film-coated tablet for dogs Chanelle Pharmaceuticals Manufacturing Limited 04/06/2010 VM Unknown AU Film-coated tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Dogs Cardiovascular VPA10987/074/003 VPA10987/074/003 Bexepril 20 mg Film-coated tablet for dogs Chanelle Pharmaceuticals Manufacturing Limited 04/06/2010 VM Unknown AU Film-coated tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Dogs Cardiovascular VPA10987/074/002 VPA10987/074/002 Bexepril 5 mg Film-coated tablet for dogs Chanelle Pharmaceuticals Manufacturing Limited 04/06/2010 VM Unknown AU Film-coated tablet QC09AA07 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Dogs Cardiovascular VPA10521/010/001 VPA10521/010/001 Big Cat Wormer Film-Coated Tablets Vetoquinol S.A. 20/03/2009 VM Unknown AU Tablet QP52AA51 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Companion Animal Medicine Cats Endoparasiticide VPA22033/055/001 VPA22033/055/001 Bilovet 200 mg/ml Solution for Injection for cattle and pigs Bimeda Animal Health Limited 09/01/2015 VM Unknown AU Solution for injection QJ01FA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Tylosin Prescription Only Medicine Cattle Pigs Antibacterial VPA22033/083/001 VPA22033/083/001 Bimacox 2.5 mg/ml Oral Suspension for Sheep and Cattle Bimeda Animal Health Limited 16/08/2024 VM Unknown AU Oral suspension QP51BC03 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Oral use Diclazuril Prescription Only Medicine Cattle Sheep Coccidiostats VPA22033/074/001 VPA22033/074/001 Bimacure 500mg Intrauterine Suspension for Cattle Bimeda Animal Health Limited 19/08/2022 VM Unknown AU Intrauterine suspension QG51AA05 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intrauterine use Cefapirin Benzathine Prescription Only Medicine Cattle Antibacterial VPA22033/037/001 VPA22033/037/001 Bimadine Powder for Oral Suspension Bimeda Animal Health Limited 01/10/1988 VM Unknown AU Powder for oral suspension QJ01EQ03 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Sulfadimidine Prescription Only Medicine Cattle Antibacterial VPA22033/001/001 VPA22033/001/001 Bimastat Oral Suspension Bimeda Animal Health Limited 01/10/1988 VM Unknown AU Oral suspension QJ01RA02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Neomycin sulphate Sulfadiazine Prescription Only Medicine Cattle Antibacterial VPA22033/056/001 VPA22033/056/001 Bimectin 10 mg/ml solution for injection for cattle, sheep and pigs Bimeda Animal Health Limited 14/04/2000 VM Unknown AU Solution for injection QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA22033/077/001 VPA22033/077/001 Bimectin 5 mg/ml Pour-On solution for Cattle Bimeda Animal Health Limited 10/12/2021 VM Unknown AU Pour-on solution QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA22033/049/001 VPA22033/049/001 Bimectin Horse Oral Paste 18.7 mg/g Bimeda Animal Health Limited 05/09/2003 VM Unknown AU Oral paste QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Horses Endectoparasiticides VPA22033/002/001 VPA22033/002/001 Bimectin Plus Solution for Injection Bimeda Animal Health Limited 16/07/2010 VM Unknown AU Solution for injection QP54AA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Clorsulon Prescription Only Medicine Cattle Endectoparasiticides VPA22033/057/001 VPA22033/057/001 Bimeprine 5 mg/ml pour-on solution for cattle Bimeda Animal Health Limited 22/06/2018 VM Unknown AU Pour-on solution QP54AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Endectoparasiticides VPA22033/038/001 VPA22033/038/001 Bimotrim Co Injection Bimeda Animal Health Limited 01/10/1988 VM Unknown AU Solution for injection QJ01EW13 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Intravenous use Trimethoprim Sulfadoxine Prescription Only Medicine Cattle Antibacterial VPA22033/039/001 VPA22033/039/001 Bimoxyl LA 150 mg/ml Suspension for Injection for Cattle, Sheep, Pigs and Dogs Bimeda Animal Health Limited 01/10/1987 VM Unknown AU Suspension for injection QJ01CA04 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Subcutaneous use Amoxicillin trihydrate Prescription Only Medicine Cattle Dogs Pigs Sheep Antibacterial VPA10436/002/001 VPA10436/002/001 Bimoxyvet LA 150 mg/ml, Suspension for Injection for cattle, sheep and pigs Laboratorios Maymo S.A.U. 10/02/2017 VM Unknown AU Suspension for injection QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Amoxicillin trihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22033/076/001 VPA22033/076/001 Bimprocil 300 mg/ml suspension for injection for cattle, sheep and pigs Bimeda Animal Health Limited 18/06/2021 VM Unknown AU Suspension for injection QJ01CE09 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Benzylpenicillin procaine Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22873/002/003 VPA22873/002/003 Biocefavet 375 mg chewable tablets for cats and dogs Axience 13/12/2024 VM Unknown AU Chewable tablet QJ01DB01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Cefalexin monohydrate Prescription Only Medicine Cats Dogs Antibacterial VPA22873/002/001 VPA22873/002/001 Biocefavet 50 mg chewable tablets for cats and dogs Axience 13/12/2024 VM Unknown AU Chewable tablet QJ01DB01 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Cefalexin monohydrate Prescription Only Medicine Cats Dogs Antibacterial VPA22873/002/002 VPA22873/002/002 Biocefavet 75 mg chewable tablets for cats and dogs Axience 13/12/2024 VM Unknown AU Chewable tablet QJ01DB01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Cefalexin monohydrate Prescription Only Medicine Cats Dogs Antibacterial VPA22873/002/004 VPA22873/002/004 Biocefavet 750 mg chewable tablets for dogs Axience 13/12/2024 VM Unknown AU Chewable tablet QJ01DB01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Cefalexin monohydrate Prescription Only Medicine Dogs Antibacterial VPA10445/002/001 VPA10445/002/001 Biocillin 1000 mg/g Powder for use in drinking water for chickens, ducks and turkeys Bela-Pharm GmbH & Co. KG 24/06/2016 VM Unknown AU Powder for use in drinking water QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate Prescription Only Medicine Chickens Duck Turkeys Antibacterial VPA22873/005/002 VPA22873/005/002 Bioclanic 250 mg + 62.5 mg flavoured tablets for cats and dogs Axience 26/07/2024 VM Unknown AU Tablet QJ01CR02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Cats Dogs Antibacterial VPA22873/005/001 VPA22873/005/001 Bioclanic 50 mg + 12.5 mg flavoured tablets for cats and dogs Axience 26/07/2024 VM Unknown AU Tablet QJ01CR02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Cats Dogs Antibacterial VPA22873/005/003 VPA22873/005/003 Bioclanic 500 mg + 125 mg flavoured tablets for dogs Axience 26/07/2024 VM Unknown AU Tablet QJ01CR02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Dogs Antibacterial VPA22873/003/001 VPA22873/003/001 Bioclindavet 110 mg/ml oral solution for cats and dogs Axience 17/10/2025 VM Unknown AU Oral solution QJ01FF01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Clindamycin hydrochloride Prescription Only Medicine Cats Dogs Antibacterial VPA22873/004/002 VPA22873/004/002 Bioclindavet 275 mg chewable tablets for dogs Axience 17/10/2025 VM Unknown AU Chewable tablet QJ01FF01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA22873/004/001 VPA22873/004/001 Bioclindavet 75 mg chewable tablet for dogs Axience 17/10/2025 VM Unknown AU Chewable tablet QJ01FF01 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA22028/010/001 VPA22028/010/001 BioEquin EHV, emulsion for injection for horses Bioveta, a.s. 05/04/2019 VM AU Emulsion for injection QI05AA05 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated equine herpes virus ehv msv bio 82S Prescription Only Medicine Horses Immunological - Inactivated Vaccine VPA22028/008/001 VPA22028/008/001 BioEquin F suspension for injection for horses Bioveta, a.s. 21/03/2025 VM Unknown AU Suspension for injection QI05AA01 Full application (Article 8 of Regulation (EU) 2019/6) Intramuscular use Equine Influenza virus H3N8, A/Equine/Limerick/2010, Inactivated Equine influenza virus H3N8, A/Equine/Brno/08, Inactivated Prescription Only Medicine Horses Immunological - Inactivated Vaccine VPA22028/009/001 VPA22028/009/001 BioEquin FT suspension for injection for horses Bioveta, a.s. 21/03/2025 VM Unknown AU Suspension for injection QI05AL01 Full application (Article 8 of Regulation (EU) 2019/6) Intramuscular use Equine Influenza virus H3N8, A/Equine/Limerick/2010, Inactivated Equine influenza virus H3N8, A/Equine/Brno/08, Inactivated Tetanus toxoid Prescription Only Medicine Horses Immunological - Inactivated Vaccine VPA10521/028/001 VPA10521/028/001 Bioestrovet 0.250 mg/ml solution for injection for cattle Vetoquinol S.A. 28/04/2017 VM Unknown AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cloprostenol sodium Prescription Only Medicine Cattle Hormone VPA10983/063/001 VPA10983/063/001 Bioestrovet Swine Vetoquinol Ireland Limited 08/07/2022 VM Unknown AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cloprostenol sodium Prescription Only Medicine Pigs Hormone VPA22028/003/001 VPA22028/003/001 BIOSUIS ParvoEry suspension for injection for pigs Bioveta, a.s. 03/09/2021 VM Unknown AU Suspension for injection QI09AL01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Porcine parvovirus inactivated erysipelothrix rhusiopathiae, inactivated Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA22028/001/001 VPA22028/001/001 BIOSUIS Salm emulsion for injection for pigs Bioveta, a.s. 11/10/2019 VM AU Emulsion for injection QI09AB14 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Salmonella enterica subsp. enterica sv. Typhimurium (wild type, fagotype: DT104) Salmonella enterica subsp. enterica sv. Derby (wild type, PFGE type: De1) Salmonella enterica subsp. enterica sv. Infantis (wild type) Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA10454/002/001 VPA10454/002/001 Bisolvon 10mg/g Oral Powder Boehringer Ingelheim Vetmedica GmbH 01/10/1991 VM Not marketed AU Oral powder QR05CB02 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Bromhexine hydrochloride Prescription Only Medicine Cats Cattle Dogs Pigs Respiratory Tract preparations VPA10387/002/001 VPA10387/002/001 Blackleg Vaccine Zoetis Belgium S.A. 25/07/2014 VM Marketed AU Suspension for injection QI02AB01 QI04AB01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Clostridium chauvoei, Inactivated Licensed Retailer Cattle Sheep Immunological - Inactivated Vaccine VPA10827/002/001 VPA10827/002/001 Blockade 2.56 mg/ml teat dip solution DeLaval NV 11/11/2002 VM Unknown AU Teat dip solution QD08AG03 Full application (Article 12(3) of Directive No 2001/82/EC) Teat use Available iodine Licensed Retailer Cattle Antiseptics VPA10509/013/001 VPA10509/013/001 Boflox flavour 20 mg tablets for dogs and cats Industrial Veterinaria S.A. 10/02/2017 VM Unknown AU Tablet QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Cats Dogs Antibacterial VPA10509/013/002 VPA10509/013/002 Boflox flavour 80 mg tablets for dogs Industrial Veterinaria S.A. 10/02/2017 VM Unknown AU Tablet QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Dogs Antibacterial VPA10509/003/001 VPA10509/003/001 Boflox, 100 mg/ml solution for injection for cattle and pigs Industrial Veterinaria S.A. 17/05/2013 VM Marketed AU Solution for injection QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Marbofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA22837/001/001 VPA22837/001/001 BONHAREN IVN 10 mg/ml solution for injection for horses and dogs Contipro a.s., 17/01/2020 VM Marketed AU Solution for injection QM09AX01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Sodium hyaluronate Prescription Only Medicine Dogs Horses Miscellaneous VPA10988/082/001 VPA10988/082/001 Borgal 200 mg/ml + 40 mg/ml solution for injection. Virbac 01/10/1998 VM Unknown AU Solution for injection QJ01EW13 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Sulfadoxine Trimethoprim Prescription Only Medicine Cattle Horses Pigs Antibacterial VPA22664/005/001 VPA22664/005/001 Bovaclox DC Intramammary Suspension Norbrook Laboratories (Ireland) Limited 01/10/1987 VM Unknown AU Intramammary suspension QJ51RC Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use Cloxacillin Benzathine Ampicillin trihydrate Prescription Only Medicine Cattle Antibacterial VPA22664/038/001 VPA22664/038/001 Bovaclox DC Xtra Intramammary Suspension Norbrook Laboratories (Ireland) Limited 11/06/1993 VM Unknown AU Intramammary suspension QJ51CR50 Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use Cloxacillin Benzathine Ampicillin trihydrate Prescription Only Medicine Cattle Antibacterial VPA10454/029/001 VPA10454/029/001 BOVALTO Respi 3 suspension for injection Boehringer Ingelheim Vetmedica GmbH 26/02/2016 VM Unknown AU Suspension for injection QI02AL Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Inactivated bovine respiratory syncytial virus, strain bio-24 Inactivated bovine parainfluenza 3 virus, strain bio-23 Inactivated mannheimia (pasteurella) haemolyica, a1 strain dsm 5283 Prescription Only Exempt Cattle Immunological - Inactivated Vaccine VPA10454/029/002 VPA10454/029/002 BOVALTO Respi 4 suspension for injection Boehringer Ingelheim Vetmedica GmbH 26/02/2016 VM Unknown AU Suspension for injection QI02AL Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Inactivated bovine respiratory syncytial virus, strain bio-24 Inactivated bovine parainfluenza 3 virus, strain bio-23 Inactivated mannheimia haemolytica serotype a1 strain dsm 5283 Inactivated bovine viral diarrhoea virus, strain bio-25 Prescription Only Exempt Cattle Immunological - Inactivated Vaccine VPA10454/029/003 VPA10454/029/003 BOVALTO RESPI INTRANASAL, nasal spray, lyophilisate and solvent for suspension Boehringer Ingelheim Vetmedica GmbH 13/04/2018 VM Unknown AU Nasal spray, lyophilisate and solvent for suspension QI02AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Nasal use Bovine respiratory syncytial virus, live Bovine parainfluenza virus 3 attenuated Prescription Only Exempt Cattle Immunological - Live Vaccine VPA10987/039/001 VPA10987/039/001 Bovex 22.65 mg/ml Oral suspension for Cattle and Sheep Chanelle Pharmaceuticals Manufacturing Limited 05/08/1992 VM Unknown AU Oral suspension QP52AC02 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Oxfendazole Prescription Only Medicine Cattle Sheep Endoparasiticide HOVR10537/005/001 HOVR10537/005/001 Bovi.BLI.Complex Galway Homeopathics (Manufacturing) Limited 08/02/2019 VM AU Oral solution Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC) Oral use Licensed Retailer Cattle Homeopathic HOVR10537/004/001 HOVR10537/004/001 Bovi.BLS.Complex Galway Homeopathics (Manufacturing) Limited 08/02/2019 VM AU Oral solution Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC) Oral use Licensed Retailer Cattle Homeopathic VPA10954/011/001 VPA10954/011/001 Bovicox 50 mg/ml oral suspension for cattle and sheep J. & M. Veterinary Services Ltd. 20/09/2013 VM Unknown AU Oral suspension QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Cattle Sheep Coccidiostats VPA10827/003/001 VPA10827/003/001 Bovidip 20 mg/ml Concentrate for Teat Dip or Spray Solution DeLaval NV 27/02/2009 VM Unknown AU Teat dip/spray solution QG52A Well-established use application (Article 13a of Directive No 2001/82/EC) Teat use Available iodine Licensed Retailer Cattle Antiseptics VPA10794/002/001 VPA10794/002/001 Bovifer 200 mg/ml solution for injection, cattle (calves) Pharmacosmos A/ S 25/08/2023 VM Unknown AU Solution for injection QB03AC Bibliographic application (Article 22 of Regulation (EU) 2019/6) Intramuscular use Iron dextran Licensed Retailer Cattle Vitamins and minerals VPA10806/004/001 VPA10806/004/001 BOVIGEN SCOUR Emulsion for injection for cattle FORTE Healthcare Ltd 01/05/2015 VM Unknown AU Emulsion for injection QI02AL01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Bovine coronavirus strain c-197 (inactivated) Bovine rotavirus strain TM-91, serotype G6P1 (inactivated). Escherichia coli strain EC/17, (inactivated) expressing F5(K99) adhesin Prescription Only Medicine Cattle Immunological - Inactivated Vaccine VPA10996/152/001 VPA10996/152/001 Bovilis Bovipast RSP suspension for injection for cattle Intervet Ireland Limited 06/06/2000 VM Unknown AU Suspension for injection QI02AL04 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Inactivated bovine respiratory syncytial virus strain ev908 Inactivated Parainfluenza-3-virus, strain SF-4 Reisinger Inactivated mannheimia (pasteurella) haemolyticaA1, strain M4/1 Prescription Only Exempt Cattle Immunological - Inactivated Vaccine VPA10996/165/001 VPA10996/165/001 Bovilis Bovivac S suspension for injection for cattle Intervet Ireland Limited 05/09/2001 VM Unknown AU Suspension for injection QI02AB Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Salmonella dublin strain s342/70 formalin inactivated Salmonella typhimurium strain s341/70 formalin inactivated Prescription Only Exempt Cattle Immunological - Inactivated Vaccine VPA10996/271/001 VPA10996/271/001 Bovilis BVD Suspension for injection for cattle Intervet Ireland Limited 30/08/1999 VM Unknown AU Suspension for injection QI02AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated antigen of cytopathogenic BVDV strain C-86 Prescription Only Exempt Cattle Immunological - Inactivated Vaccine VPA10996/081/001 VPA10996/081/001 Bovilis Huskvac oral suspension for cattle Intervet Ireland Limited 22/12/2003 VM Marketed AU Oral suspension QI02AN01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Inactivated cells and equivalent toxoid of irradiated 3rd stage of dictyocaulus vivipatrous Prescription Only Exempt Cattle Immunological - Live Vaccine VPA10996/200/001 VPA10996/200/001 Bovilis IBR Marker inac suspension for injection for cattle Intervet Ireland Limited 05/07/2006 VM Unknown AU Suspension for injection QI02AA03 Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC) Intramuscular use Inactivated antigen of BHV-1 (gE) strain GK/D Prescription Only Exempt Cattle Immunological - Inactivated Vaccine VPA10996/172/001 VPA10996/172/001 Bovilis IBR marker live, lyophilisate and solvent for suspension for cattle Intervet Ireland Limited 24/10/2002 VM Marketed AU Lyophilisate and solvent for suspension for injection QI02AD01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intranasal use Glycoprotein E deficient (gE-) Bovine Herpes Virus Type 1 (BHV-1), strain GK/D (gE-)1 Prescription Only Exempt Cattle Immunological - Live Vaccine VPA10996/276/001 VPA10996/276/001 Bovilis INtranasal RSP Live, nasal spray, lyophilisate and solvent for suspension for cattle Intervet Ireland Limited 14/06/2019 VM AU Lyophilisate and solvent for suspension for nasal administration QI02AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Nasal use Bovine respiratory syncytial virus (live) strain Jencine-2013 Bovine parainfluenza virus type 3 (live) strain INT2-2013 Prescription Only Exempt Cattle Immunological - Live Vaccine VPA10996/235/001 VPA10996/235/001 Bovilis Leptavoid-H Suspension for injection for cattle Intervet Ireland Limited 15/01/2003 VM Unknown AU Suspension for injection QI02AB03 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Leptospira interrogans serovar hardjo 204 (inactivated) Licensed Retailer Cattle Immunological - Inactivated Vaccine VPA10996/216/001 VPA10996/216/001 Bovilis Rotavec Corona emulsion for injection for cattle Intervet Ireland Limited 24/09/2010 VM Unknown AU Emulsion for injection QI02AL01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Bovine rotavirus, strain UK-Compton, serotype G6 P5 (inactivated) Bovine coronavirus Escherichia coli, strain O101:K99:F41, fimbrial adhesin F5 and F41, Inactivated Prescription Only Medicine Cattle Immunological - Inactivated Vaccine VPA22033/003/001 VPA22033/003/001 Bovimast DC, 500 mg cloxacillin/syringe, Intramammary suspension Bimeda Animal Health Limited 08/07/2004 VM Unknown AU Intramammary suspension QJ51CF02 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramammary use Cloxacillin Benzathine Prescription Only Medicine Cattle Antibacterial VPA10987/162/001 VPA10987/162/001 Bovipour 5 mg/ml Pour-on Solution for Cattle Chanelle Pharmaceuticals Manufacturing Limited 25/05/2007 VM Not marketed AU Pour-on solution QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10387/101/001 VPA10387/101/001 Boviseal Dry cow intramammary suspension Zoetis Belgium S.A. 20/11/2020 VM Unknown AU Intramammary suspension QG52X Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use Bismuth subnitrate, heavy Licensed Retailer Cattle Miscellaneous VPA10793/003/001 VPA10793/003/001 Bovitec Plus Oral Suspension Acravet Limited 28/11/1997 VM Unknown AU Oral suspension QP52AC11 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Albendazole Prescription Only Medicine Cattle Endoparasiticide VPA10420/002/001 VPA10420/002/001 Bromhex-Air forte 25 mg/g oral powder for cattle, pigs, chickens, turkeys and ducks Pharmanovo Veterinärarzneimittel GmbH 03/09/2021 VM Unknown AU Oral powder QR05CB02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use In-feed use Bromhexine hydrochloride Prescription Only Medicine Cattle Chickens Duck Pigs Turkeys Respiratory Tract preparations VPA10454/083/001 VPA10454/083/001 BULTAVO 3 suspension for injection for sheep and cattle Boehringer Ingelheim Vetmedica GmbH 17/04/2025 VM Unknown AU Suspension for injection QI04AA02 Applications in exceptional circumstances (Article 25 of Regulation (EU) 2019/6) Intramuscular use Subcutaneous use Bluetongue virus, serotype 3, strain Bio-93:BTV3, Inactivated Prescription Only Medicine Cattle Sheep Immunological - Inactivated Vaccine VPA23462/003/001 VPA23462/003/001 Bupaq Multidose 0.3 mg/ml Solution for Injection for Dogs and Cats VetViva Richter GmbH 21/10/2011 VM Unknown AU Solution for injection QN02AE01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Buprenorphine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10491/004/001 VPA10491/004/001 Buprecare 0.3 mg/ml Solution for Injection for Dogs and Cats Ecuphar N.V. 16/05/2008 VM Unknown AU Solution for injection QN02AE01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Buprenorphine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10491/004/002 VPA10491/004/002 Buprecare Multidose 0.3 mg/ml Solution for Injection for Dogs and Cats Ecuphar N.V. 16/12/2011 VM Unknown AU Solution for injection QN02AE01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Buprenorphine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10402/009/001 VPA10402/009/001 Buprecord 0.3 mg/ml solution for injection for dogs and cats Labiana Life Sciences, S.A. 13/12/2024 VM Unknown AU Solution for injection QN02AE01 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Buprenorphine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10475/021/001 VPA10475/021/001 Buprefelican Multidose 0.3 mg/ml solution for injection for dogs and cats Le Vet Beheer B.V. 27/11/2015 VM Unknown AU Solution for injection QN02AE01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Buprenorphine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10980/049/001 VPA10980/049/001 Buproxan Multidose 0.3 mg/ml solution for injection for dogs, cats and horses Alfasan Nederland B.V. 17/04/2026 VM Unknown AU Solution for injection QN02AE01 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Buprenorphine hydrochloride Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA10454/004/001 VPA10454/004/001 Buscopan Compositum Solution for Injection Boehringer Ingelheim Vetmedica GmbH 01/10/1991 VM Unknown AU Solution for injection QA03DB04 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Intravenous use Hyoscine butylbromide Metamizole Prescription Only Medicine Cattle Dogs Horses Spasmolytic VPA10826/027/001 VPA10826/027/001 Busol 0.004 mg/ml solution for injection for cattle, horses, rabbits aniMedica GmbH 05/09/2008 VM Marketed AU Solution for injection QH01CA90 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Buserelin Prescription Only Medicine Cattle Horses Rabbits Hormone VPA23462/002/001 VPA23462/002/001 Butador 10 mg/ml solution for injection for horses, dogs and cats VetViva Richter GmbH 27/05/2011 VM Unknown AU Solution for injection QN02AF01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Butorphanol tartrate Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA22812/003/001 VPA22812/003/001 Butasal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle and dogs Interchemie Werken De Adelaar Eesti AS. 23/07/2021 VM Unknown AU Solution for injection QA12CX99 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Cyanocobalamin Butaphosphan (Butafosfan) Prescription Only Medicine Cattle Dogs Horses Vitamins and minerals VPA10987/178/001 VPA10987/178/001 ButorVet 10 mg/ml solution for injection Chanelle Pharmaceuticals Manufacturing Limited 11/10/2024 VM Unknown AU Solution for injection QN02AF01 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Subcutaneous use Butorphanol tartrate Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA10996/103/001 VPA10996/103/001 Butox 7.5 mg/ml Pour On Suspension Intervet Ireland Limited 01/10/1999 VM Unknown AU Pour-on suspension QP53AC11 Complete application (stand-alone) - Council Directive 81/851/EEC Pour-on use Deltamethrin Prescription Only Medicine Cattle Sheep Ectoparasiticide VPA22020/049/001 VPA22020/049/001 ByeMite 500 mg/ml concentrate for spraying emulsion for laying hens Elanco GmbH 20/02/2009 VM Marketed AU Concentrate for cutaneous spray, emulsion QP53AF01 Generic application (Article 13(1) of Directive No 2001/82/EC) Coarse spray Phoxim Prescription Only Medicine Chickens Ectoparasiticide VPA10509/011/001 VPA10509/011/001 Cadorex 300 mg/ml solution for injection for cattle, sheep and pigs Industrial Veterinaria S.A. 19/05/2017 VM Marketed AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Florfenicol Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10445/003/001 VPA10445/003/001 Calcibel 240/60/60 mg/ml solution for infusion for horses, cattle, sheep, goats and pigs Bela-Pharm GmbH & Co. KG 22/04/2016 VM Unknown AU Solution for infusion QA12AX Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intravenous use Calcium gluconate Magnesium chloride hexahydrate Boric acid Prescription Only Medicine Cattle Goats Horses Pigs Sheep Vitamins and minerals VPA10445/007/001 VPA10445/007/001 Calcibel Forte, 380/60/50 mg/ml solution for infusion for horses, cattle, sheep, goats and pigs Bela-Pharm GmbH & Co. KG 12/11/2021 VM Unknown AU Solution for infusion QA12AX Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Calcium gluconate for injection Magnesium chloride hexahydrate Boric acid Prescription Only Medicine Cattle Goats Horses Pigs Sheep Vitamins and minerals VPA22664/032/001 VPA22664/032/001 Calciject 40 + 3 Solution for Injection Norbrook Laboratories (Ireland) Limited 01/10/1991 VM Unknown AU Solution for injection QA12 Complete application (stand-alone) - Council Directive 81/851/EEC Intravenous use Subcutaneous use Calcium gluconate Magnesium hypophosphite hexahydrate Boric acid Licensed Retailer Cattle Vitamins and minerals VPA22664/031/001 VPA22664/031/001 Calciject 40 Solution for Injection Norbrook Laboratories (Ireland) Limited 01/10/1991 VM Unknown AU Solution for injection QA12A Complete application (stand-alone) - Council Directive 81/851/EEC Intravenous use Subcutaneous use Calcium borogluconate Boric acid Licensed Retailer Cattle Vitamins and minerals VPA10823/015/001 VPA10823/015/001 Calcipharm 40 Solution for Injection Chem-Pharm Limited 01/10/2001 VM AU Solution for injection QA12AA Informed consent application (Article 13c of Directive No 2001/82/EC) Intravenous use Subcutaneous use Calcium borogluconate Boric acid Licensed Retailer Cattle Vitamins and minerals VPA10826/001/001 VPA10826/001/001 Calcitat 25, solution for infusion and injection in cattle aniMedica GmbH 01/10/1989 VM Marketed AU Solution for injection/infusion QA12AA Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Subcutaneous use Calcium gluconate monohydrate Calcium borogluconate Calcium hydroxide Magnesium chloride hexahydrate Licensed Retailer Cattle Vitamins and minerals VPA10826/001/002 VPA10826/001/002 Calcitat 50, solution for infusion and injection in cattle aniMedica GmbH 01/10/1989 VM Marketed AU Solution for injection/infusion QA12AA Complete application (stand-alone) - Council Directive 81/851/EEC Intravenous use Subcutaneous use Calcium gluconate monohydrate Calcium borogluconate Calcium hydroxide Magnesium chloride hexahydrate Licensed Retailer Cattle Vitamins and minerals VPA22664/054/001 VPA22664/054/001 Calcivet Solution for Injection for Cattle Norbrook Laboratories (Ireland) Limited 02/10/2000 VM Unknown AU Solution for injection QA12A Informed consent application (Article 13c of Directive No 2001/82/EC) Intravenous use Subcutaneous use Calcium gluconate Boric acid Magnesium hypophosphite hexahydrate Licensed Retailer Cattle Vitamins and minerals VPA22812/001/001 VPA22812/001/001 Calmafusion, 380mg/60mg/50mg, solution for infusion for cattle, sheep and pigs Interchemie Werken De Adelaar Eesti AS. 17/01/2020 VM Unknown AU Solution for infusion QA12AX Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Calcium gluconate for injection Magnesium chloride hexahydrate Boric acid Prescription Only Medicine Cattle Pigs Sheep Vitamins and minerals VPA10803/003/001 VPA10803/003/001 Canaural ear drops, suspension for dogs and cats Dechra Veterinary Products A/S 01/10/2004 VM Unknown AU Ear drops, suspension QS02CA01 Complete application (stand-alone) - Council Directive 81/851/EEC Auricular use Diethanolamine Fusidate Framycetin sulphate Nystatin Prednisolone Prescription Only Medicine Cats Dogs Antibacterial VPA10475/016/001 VPA10475/016/001 Canergy 100 mg tablets for dogs Le Vet Beheer B.V. 29/05/2015 VM Unknown AU Tablet QC04AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Propentofylline Prescription Only Medicine Dogs Cardiovascular VPA10987/064/003 VPA10987/064/003 Canidryl 100 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 03/03/2006 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/064/001 VPA10987/064/001 Canidryl 20 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 03/03/2006 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/064/002 VPA10987/064/002 Canidryl 50 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 03/03/2006 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10996/048/001 VPA10996/048/001 Caninsulin 40 IU/ml Suspension for Injection Intervet Ireland Limited 10/01/1997 VM Unknown AU Suspension for injection QA10AC03 Complete application (stand-alone) - Council Directive 81/851/EEC Subcutaneous use Insulin Prescription Only Medicine Cats Dogs Hormone VPA10455/003/002 VPA10455/003/002 Canishield 0.77 g medicated collar for small and medium sized dogs Beaphar B.V. 22/11/2019 VM Unknown AU Medicated collar QP53AC11 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Cutaneous use Deltamethrin Prescription Only Medicine Dogs Ectoparasiticide VPA10455/003/001 VPA10455/003/001 Canishield 1.04 g medicated collar for large sized dogs Beaphar B.V. 21/09/2018 VM AU Medicated collar QP53AC11 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Cutaneous use Deltamethrin Prescription Only Medicine Dogs Ectoparasiticide VPA10988/101/002 VPA10988/101/002 CANIXIN DHPPi/L lyophilisate suspension for injection for dogs Virbac 11/12/2015 VM Unknown AU Lyophilisate and suspension for suspension for injection QI07AI02 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Canine distemper virus Canine adenovirus type 2 Canine parvovirus Canine parainfluenza L.canicola L. icterohaemorrhagiae Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10988/101/001 VPA10988/101/001 CANIXIN DHPPi lyophilisate and solvent for suspension for injection for dogs Virbac 16/09/2016 VM Unknown AU Lyophilisate and solvent for suspension for injection QI07AD04 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Canine distemper virus (lederle strain) Canine parvovirus (cpv 780916 strain) Canine adenovirus type 2 (manhattan strain) Canine parainfluenza (manhattan strain) Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10988/102/001 VPA10988/102/001 Canixin L suspension for injection for dogs Virbac 24/03/2017 VM Unknown AU Suspension for injection QI07AB01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Leptospira interrogans serogroup icterohaemorragiae, inactivated Leptospira interrogans serogroup canicola, inactivated Prescription Only Medicine Dogs Immunological - Inactivated Vaccine VPA10988/103/001 VPA10988/103/001 CANIXIN Pi/L lyophilisate and suspension for suspension for injection for dogs Virbac 13/04/2017 VM Unknown AU Lyophilisate and suspension for suspension for injection QI07AI08 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Canine Parainfluenza, live Leptospira interrogans serogroup canicola, inactivated Leptospira interrogans serogroup icterohaemorragiae, inactivated Prescription Only Medicine Dogs Immunological VPA10980/024/001 VPA10980/024/001 Cardisan 1.25 mg chewable tablets for dogs Alfasan Nederland B.V. 07/10/2022 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10980/024/004 VPA10980/024/004 Cardisan 10 mg chewable tablets for dogs Alfasan Nederland B.V. 07/10/2022 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10980/024/005 VPA10980/024/005 Cardisan 15 mg chewable tablets for dogs Alfasan Nederland B.V. 07/10/2022 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10980/024/002 VPA10980/024/002 Cardisan 2.5 mg chewable tablets for dogs Alfasan Nederland B.V. 07/10/2022 VM Unknown AU Chewable tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10980/024/003 VPA10980/024/003 Cardisan 5 mg chewable tablets for dogs Alfasan Nederland B.V. 07/10/2022 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10989/059/003 VPA10989/059/003 Cardisure flavoured 5 mg Tablets For dogs Eurovet Animal Health B.V. 22/07/2011 VM Unknown AU Tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA22622/026/001 VPA22622/026/001 Cardisure 3.5 mg/ml Oral Solution for Dogs Dechra Regulatory B.V. 13/09/2019 VM AU Oral solution QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10989/059/001 VPA10989/059/001 Cardisure flavoured 1.25 mg Tablets For dogs Eurovet Animal Health B.V. 22/07/2011 VM Unknown AU Tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10989/059/004 VPA10989/059/004 Cardisure flavoured 10 mg Tablets For dogs Eurovet Animal Health B.V. 22/07/2011 VM Unknown AU Tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10989/059/002 VPA10989/059/002 Cardisure flavoured 2.5 mg Tablets For dogs Eurovet Animal Health B.V. 22/07/2011 VM Unknown AU Tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA16142/004/001 VPA16142/004/001 Carofertin 10 mg/ml Emulsion for injection for cattle and pigs V.M.D. n.v., 12/02/2016 VM Not marketed AU Emulsion for injection QA11CA02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Betacarotene Prescription Only Medicine Cattle Pigs Vitamins and minerals VPA10980/047/002 VPA10980/047/002 Carpcoat 20 mg film-coated tablets for dogs Alfasan Nederland B.V. 10/10/2025 VM Unknown AU Film-coated tablet QM01AE91 Hybrid application (Article 19(1) of Regulation (EU) 2019/6) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10980/047/003 VPA10980/047/003 Carpcoat 40 mg film-coated tablets for dogs Alfasan Nederland B.V. 10/10/2025 VM Unknown AU Film-coated tablet QM01AE91 Hybrid application (Article 19(1) of Regulation (EU) 2019/6) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10980/047/001 VPA10980/047/001 Carpcoat 8 mg film-coated tablets for dogs Alfasan Nederland B.V. 10/10/2025 VM Unknown AU Film-coated tablet QM01AE91 Hybrid application (Article 19(1) of Regulation (EU) 2019/6) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10980/047/004 VPA10980/047/004 Carpcoat 80 mg film-coated tablets for dogs Alfasan Nederland B.V. 10/10/2025 VM Unknown AU Film-coated tablet QM01AE91 Hybrid application (Article 19(1) of Regulation (EU) 2019/6) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10475/019/002 VPA10475/019/002 Carporal 160 mg tablets for dogs Le Vet Beheer B.V. 10/07/2015 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10475/019/001 VPA10475/019/001 Carporal 40 mg tablets for dogs Le Vet Beheer B.V. 10/07/2015 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA22664/071/003 VPA22664/071/003 Carprieve 100 mg tablets for Dogs Norbrook Laboratories (Ireland) Limited 08/01/2010 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA22664/071/001 VPA22664/071/001 Carprieve 20 mg Tablets for Dogs Norbrook Laboratories (Ireland) Limited 25/07/2003 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA22664/080/001 VPA22664/080/001 Carprieve 50 mg/ml Solution for Injection for Cattle Norbrook Laboratories (Ireland) Limited 04/05/2007 VM Unknown AU Solution for injection QM01AE91 Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Cattle N.S.A.I.D. VPA22664/071/002 VPA22664/071/002 Carprieve 50 mg Tablets for Dogs Norbrook Laboratories (Ireland) Limited 25/07/2003 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/065/003 VPA10987/065/003 Carprochem 100 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 02/06/2006 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10475/003/001 VPA10475/003/001 Carprodolor 50 mg/ml solution for injection for cattle Le Vet Beheer B.V. 12/04/2013 VM Unknown AU Solution for injection QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Cattle N.S.A.I.D. VPA10815/045/002 VPA10815/045/002 Carprodyl Quadri 120 mg chewable tablets for dogs Ceva Santé Animale 24/03/2017 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10815/045/001 VPA10815/045/001 Carprodyl Quadri 50 mg tablets for dogs Ceva Santé Animale 24/03/2017 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10475/007/001 VPA10475/007/001 Carprofelican 50 mg/ml solution for injection for dogs and cats Le Vet Beheer B.V. 09/08/2013 VM Unknown AU Solution for injection QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Cats Dogs N.S.A.I.D. VPA10774/019/001 VPA10774/019/001 Carprofen KRKA 50 mg/ml solution for injection for dogs and cats Krka, d.d., Novo mesto 21/06/2013 VM Not marketed AU Solution for injection QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Cats Dogs N.S.A.I.D. VPA22664/152/001 VPA22664/152/001 Carprofen Norbrook 50 mg/ml solution for injection for cattle Norbrook Laboratories (Ireland) Limited 23/01/2026 VM Unknown AU Solution for injection QM01AE91 Generic application (Article 18 of Regulation (EU) 2019/6) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Cattle N.S.A.I.D. VPA22664/079/001 VPA22664/079/001 Carprogesic 20 mg Tablets for dogs Norbrook Laboratories (Ireland) Limited 08/12/2006 VM Unknown AU Tablet QM01AE91 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA22664/079/002 VPA22664/079/002 Carprogesic 50 mg Tablets for dogs Norbrook Laboratories (Ireland) Limited 08/12/2006 VM Unknown AU Tablet QM01AE91 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10980/046/003 VPA10980/046/003 Cartaxx 100 mg chewable tablets for dogs Alfasan Nederland B.V. 10/10/2025 VM Unknown AU Chewable tablet QM01AE91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10980/046/001 VPA10980/046/001 Cartaxx 20 mg chewable tablets for dogs Alfasan Nederland B.V. 10/10/2025 VM Unknown AU Chewable tablet QM01AE91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10980/040/001 VPA10980/040/001 Cartaxx 50 mg/ml solution for injection for dogs and cats Alfasan Nederland B.V. 19/01/2024 VM Unknown AU Solution for injection QM01AE91 Generic application (Article 18 of Regulation (EU) 2019/6) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Cats Dogs N.S.A.I.D. VPA10980/046/002 VPA10980/046/002 Cartaxx 50 mg chewable tablets for dogs Alfasan Nederland B.V. 10/10/2025 VM Unknown AU Chewable tablet QM01AE91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA22748/001/001 VPA22748/001/001 Cartrophen Vet 100 mg/ml Solution for Injection. Maperath Herbal Limited 01/10/1991 VM Unknown AU Solution for injection QM01AX90 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Pentosan Polysulfate Sodium Prescription Only Medicine Dogs Miscellaneous VPA10774/052/001 VPA10774/052/001 Catobevit 100 mg/ml + 0.05 mg/ml solution for injection for cattle, horses, dogs Krka, d.d., Novo mesto 07/01/2019 VM Not marketed AU Solution for injection QA12CX99 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Butaphosphan (Butafosfan) Cyanocobalamin Prescription Only Medicine Cats Cattle Dogs Horses Vitamins and minerals VPA10810/022/001 VPA10810/022/001 Catophos 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle and dogs CP-Pharma Handelsgesellschaft mbH 01/09/2023 VM Unknown AU Solution for injection QA12CX99 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Butaphosphan (Butafosfan) Cyanocobalamin Prescription Only Medicine Cattle Dogs Horses Vitamins and minerals VPA10987/102/001 VPA10987/102/001 Cazitel 230/20 mg Flavoured Film-Coated Tablets for Cats Chanelle Pharmaceuticals Manufacturing Limited 04/07/2013 VM Unknown AU Film-coated tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pyrantel embonate Praziquantel Companion Animal Medicine Cats Endoparasiticide VPA10987/077/001 VPA10987/077/001 Cazitel Plus Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 20/03/2009 VM Unknown AU Tablet QP52AA51 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10987/077/002 VPA10987/077/002 Cazitel Plus XL Tablets For Dogs Chanelle Pharmaceuticals Manufacturing Limited 02/03/2012 VM Unknown AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10475/024/004 VPA10475/024/004 Cefabactin 1000 mg tablets for dogs Le Vet Beheer B.V. 30/09/2016 VM Unknown AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin monohydrate Prescription Only Medicine Dogs Antibacterial VPA10475/024/002 VPA10475/024/002 Cefabactin 250 mg tablets for dogs and cats Le Vet Beheer B.V. 30/09/2016 VM Unknown AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin monohydrate Prescription Only Medicine Cats Dogs Antibacterial VPA10475/024/001 VPA10475/024/001 Cefabactin 50 mg tablets for dogs and cats Le Vet Beheer B.V. 30/09/2016 VM Unknown AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin monohydrate Prescription Only Medicine Cats Dogs Antibacterial VPA10475/024/003 VPA10475/024/003 Cefabactin 500 mg tablets for dogs Le Vet Beheer B.V. 30/09/2016 VM Unknown AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin monohydrate Prescription Only Medicine Dogs Antibacterial VPA10983/044/002 VPA10983/044/002 Cefaseptin 300 mg tablets for dogs Vetoquinol Ireland Limited 15/01/2016 VM Unknown AU Tablet QJ01DB01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Cefalexin Prescription Only Medicine Dogs Antibacterial VPA10983/044/001 VPA10983/044/001 Cefaseptin 75 mg tablets for dogs and cats Vetoquinol Ireland Limited 15/01/2016 VM Unknown AU Tablet QJ01DB01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Cefalexin Prescription Only Medicine Cats Dogs Antibacterial VPA10983/044/003 VPA10983/044/003 Cefaseptin 750 mg tablets for dogs Vetoquinol Ireland Limited 15/01/2016 VM Unknown AU Tablet QJ01DB01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Cefalexin Prescription Only Medicine Dogs Antibacterial VPA10790/005/001 VPA10790/005/001 Cefavex 50 mg/ml, suspension for injection for pigs and cattle SP Veterinaria, S.A. 10/05/2013 VM Not marketed AU Suspension for injection QJ01DD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Ceftiofur hydrochloride Prescription Only Medicine Cattle Pigs Antibacterial VPA10534/003/001 VPA10534/003/001 Ceffect 25 mg/ml suspension for injection for cattle and pigs Emdoka 07/12/2012 VM Unknown AU Suspension for injection QJ01DE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cefquinome sulfate Prescription Only Medicine Cattle Pigs Antibacterial VPA10534/005/001 VPA10534/005/001 Ceffect LC, 75 mg, intramammary ointment for lactating cows Emdoka 09/05/2014 VM Unknown AU Intramammary ointment QJ51DE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramammary use Cefquinome sulfate Prescription Only Medicine Cattle Antibacterial VPA10981/015/001 VPA10981/015/001 CEFOKEL 50 mg/ml, suspension for injection for pigs and cattle Kela n.v. 14/06/2013 VM Unknown AU Suspension for injection QJ01DD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Ceftiofur hydrochloride Prescription Only Medicine Cattle Pigs Antibacterial VPA10436/001/001 VPA10436/001/001 Cemay 50 mg/ml suspension for injection for pigs and cattle Laboratorios Maymo S.A.U. 13/09/2013 VM Unknown AU Suspension for injection QJ01DD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Ceftiofur hydrochloride Prescription Only Medicine Cattle Pigs Antibacterial VPA23448/001/001 VPA23448/001/001 Censulfatrim 200 mg/ml + 40 mg/ml solution for injection Cenavisa S.L 07/07/2023 VM Unknown AU Solution for injection QJ01EW10 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Subcutaneous use Sulfadiazine Trimethoprim Prescription Only Medicine Cats Cattle Dogs Horses Pigs Antibacterial VPA10810/035/001 VPA10810/035/001 Cepfenicol 5 mg/ml eye drops, solution for dogs and cats CP-Pharma Handelsgesellschaft mbH 02/08/2024 VM Unknown AU Eye drops, solution QS01AA01 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Ocular use Chloramphenicol Prescription Only Medicine Cats Dogs Antibacterial VPA10810/036/001 VPA10810/036/001 Cepfenidex 2 mg/ml + 1 mg/ml eye drops, solution for dogs and cats CP-Pharma Handelsgesellschaft mbH 30/08/2024 VM Unknown AU Eye drops, emulsion QS01CA01 Full application - New active substance (Article 12(3) of Directive No 2001/82/EC) Ocular use Chloramphenicol Dexamethasone sodium phosphate Prescription Only Medicine Cats Dogs Antibacterial VPA10491/005/004 VPA10491/005/004 Cephacare Flavour 1000 mg Tablets for Dogs Ecuphar N.V. 01/03/2017 VM Unknown AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin monohydrate Prescription Only Medicine Dogs Antibacterial VPA10491/005/002 VPA10491/005/002 Cephacare flavour 250 mg tablets for dogs Ecuphar N.V. 19/12/2008 VM Unknown AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin monohydrate Prescription Only Medicine Dogs Antibacterial VPA10491/005/001 VPA10491/005/001 Cephacare flavour 50 mg tablets for cats and dogs Ecuphar N.V. 19/12/2008 VM Marketed AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin monohydrate Prescription Only Medicine Cats Dogs Antibacterial VPA10491/005/003 VPA10491/005/003 Cephacare flavour 500 mg tablets for dogs Ecuphar N.V. 19/12/2008 VM Unknown AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin monohydrate Prescription Only Medicine Dogs Antibacterial VPA10988/083/001 VPA10988/083/001 Cephaguard DC 150 mg intramammary ointment Virbac S.A. 28/11/2008 VM Unknown AU Intramammary ointment QJ51DA92 Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use Cefquinome Prescription Only Medicine Cattle Antibacterial VPA10996/223/001 VPA10996/223/001 Ceporex 180 mg/ml Suspension for Injection for cattle. cats, and dogs Intervet Ireland Limited 01/10/1998 VM Unknown AU Suspension for injection QJ01DB01 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Subcutaneous use Cefalexin Sodium Prescription Only Medicine Cats Cattle Dogs Antibacterial VPA10996/287/001 VPA10996/287/001 Cepralock 2.6 g intramammary suspension for Dry Cows Intervet Ireland Limited 22/01/2021 VM Unknown AU Intramammary suspension QG52X Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Bismuth subnitrate Licensed Retailer Cattle Miscellaneous VPA10996/282/001 VPA10996/282/001 CepraShort 300 mg Intramammary Suspension for dairy cows at drying-off Intervet Ireland Limited 11/02/2022 VM Unknown AU Intramammary suspension QJ51DB08 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Cefapirin Benzathine Prescription Only Medicine Cattle Antibacterial VPA10996/224/001 VPA10996/224/001 Cepravin Dry Cow 250 mg intramammary suspension for cattle Intervet Ireland Limited 01/10/1988 VM Unknown AU Intramammary suspension QJ51DA90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use Cefalonium dihydrate Prescription Only Medicine Cattle Antibacterial VPA22664/142/001 VPA22664/142/001 Cepritect 250 mg Intramammary Suspension for Dry Cows Norbrook Laboratories (Ireland) Limited 15/12/2017 VM Unknown AU Intramammary suspension QJ51DB90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Cefalonium dihydrate Prescription Only Medicine Cattle Antibacterial VPA10836/013/001 VPA10836/013/001 Cetrimilk 250 mg intramammary suspension for cattle FATRO S.p.A. 31/07/2026 VM Unknown AU Intramammary suspension QJ51DB10 Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6) Intramammary use Cefacetrile sodium Prescription Only Medicine Cattle Antibacterial VPA10815/020/001 VPA10815/020/001 Cevac IBD 2512 L lyophilisate for oral suspension for chickens Ceva Santé Animale 14/12/2012 VM Unknown AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD09 Similar biological application (Article 13(4) of Directive No 2001/82/EC) Oral use Live infectious bursal disease (ibd) virus strain, winterfield 2512, g-61 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10815/022/001 VPA10815/022/001 CEVAC IBird lyophilisate for suspension for chickens Ceva Santé Animale 23/08/2013 VM Unknown AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Coarse spray In drinking water use Live attenuated infectious bronchitis (ib) virus, strain 1/96, variant subtype Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10463/004/001 VPA10463/004/001 CEVAC MASS L lyophilisate for oculonasal suspension CEVA-Phylaxia Veterinary Biologicals Co. Ltd 20/05/2016 VM Unknown AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Nebulisation use Live attenuated infectious bronchitis disease virus, Massachusetts type, strain B48 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10463/005/001 VPA10463/005/001 Cevac MD HVT suspension and solvent for suspension for injection for chickens CEVA-Phylaxia Veterinary Biologicals Co. Ltd 02/12/2016 VM Unknown AU Suspension and solvent for suspension for injection QI01AD03 Full application (Article 12(3) of Directive No 2001/82/EC) In ovo Subcutaneous use Turkey herpesirus, live Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10463/007/001 VPA10463/007/001 Cevac MD Rispens concentrate and solvent for suspension for injection for chickens CEVA-Phylaxia Veterinary Biologicals Co. Ltd 25/08/2020 VM AU Concentrate and solvent for suspension for injection QI01AD03 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Marek's disease virus strain cvi 988 live Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10463/003/001 VPA10463/003/001 Cevac Meta L lyophilisate for oculonasal suspension for chickens CEVA-Phylaxia Veterinary Biologicals Co. Ltd 11/11/2016 VM Not marketed AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD01 Full application (Article 12(3) of Directive No 2001/82/EC) Oculonasal use Avian metapneumovirus, subtype B, CRR126 strain Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10815/063/001 VPA10815/063/001 Cevac Salmovac Lyophilisate for use in drinking water for chickens Ceva Santé Animale 05/03/2004 VM Not marketed AU Oral lyophilisate QI01AE01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Salmonella enteritidis, strain no. 441/014 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10815/005/001 VPA10815/005/001 CEVAC TRANSMUNE lyophilisate and solvent for suspension for injection Ceva Santé Animale 26/11/2007 VM Not marketed AU Lyophilisate and solvent for suspension for injection QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) In ovo Subcutaneous use Live, attenuated infectious bursal disease (IBD) virus, strain winterfield 2512, G-61 Prescription Only Medicine Chickens Immunological VPA10815/016/001 VPA10815/016/001 Cevaxel-RTU 50 mg/ml, suspension for injection for cattle and pigs Ceva Santé Animale 21/04/2011 VM Unknown AU Suspension for injection QJ01DD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Ceftiofur hydrochloride Prescription Only Medicine Cattle Pigs Antibacterial VPA10815/007/001 VPA10815/007/001 Cevazuril 50 mg/ml, oral suspension for piglets and calves Ceva Santé Animale 25/06/2010 VM Unknown AU Oral suspension QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Cattle Pigs Coccidiostats VPA10987/054/001 VPA10987/054/001 Chan Pen Strep Suspension for Injection for Cattle, Sheep and Pigs Chanelle Pharmaceuticals Manufacturing Limited 18/08/2000 VM Unknown AU Suspension for injection QJ01RA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Procaine benzylpenicillin Dihydrostreptomycin sulphate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10987/033/001 VPA10987/033/001 Chanatol Oral Solution Chanelle Pharmaceuticals Manufacturing Limited 01/10/1991 VM Unknown AU Oral solution QA16QA Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Cobalt sulphate heptahydrate Propylene glycol Licensed Retailer Cattle Goats Sheep Vitamins and minerals VPA10987/008/001 VPA10987/008/001 Chanaverm Plus Oral Solution Chanelle Pharmaceuticals Manufacturing Limited 01/10/1989 VM Unknown AU Oral solution QP52AE51 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Levamisole hydrochloride Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10987/031/001 VPA10987/031/001 Chanazine 100 mg/ml Solution for Injection Chanelle Pharmaceuticals Manufacturing Limited 01/10/1990 VM Unknown AU Solution for injection QN05CM92 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Intravenous use Xylazine Prescription Only Medicine Horses Neurological Preparations VPA10987/030/001 VPA10987/030/001 Chanazine 20 mg/ml Solution for Injection Chanelle Pharmaceuticals Manufacturing Limited 01/10/1990 VM Unknown AU Solution for injection QN05CM92 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Intravenous use Xylazine Prescription Only Medicine Cats Cattle Dogs Horses Neurological Preparations VPA10987/169/001 VPA10987/169/001 Chanear Chanelle Pharmaceuticals Manufacturing Limited 23/02/2023 VM Unknown AU Ear drops, suspension QS02CA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Auricular use Cutaneous use Miconazole nitrate Prednisolone acetate Polymyxin b sulfate Prescription Only Medicine Cats Dogs Antibacterial VPA10987/154/001 VPA10987/154/001 Chanectin 0.5% w/v Pour-on Solution Chanelle Pharmaceuticals Manufacturing Limited 03/12/2004 VM Not marketed AU Pour-on solution QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/149/001 VPA10987/149/001 Chanectin 1 % Solution for Injection for Cattle Chanelle Pharmaceuticals Manufacturing Limited 20/06/2001 VM Not marketed AU Solution for injection QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/114/001 VPA10987/114/001 Chanil 34 mg/ml oral suspension for cattle Chanelle Pharmaceuticals Manufacturing Limited 19/02/2016 VM Unknown AU Oral suspension QP52AG06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Oxyclozanide Prescription Only Medicine Cattle Endoparasiticide VPA10987/155/001 VPA10987/155/001 Chanimec 0.5% w/v Pour-on Solution Chanelle Pharmaceuticals Manufacturing Limited 03/12/2004 VM Not marketed AU Pour-on solution QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/081/001 VPA10987/081/001 CHANIMEC 0.8 mg/ml Oral Solution for Sheep Chanelle Pharmaceuticals Manufacturing Limited 24/07/2009 VM Not marketed AU Oral solution QP54AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA10987/145/001 VPA10987/145/001 Chanimec 10 mg/ml solution for injection for Cattle, Pigs and Sheep Chanelle Pharmaceuticals Manufacturing Limited 14/04/2000 VM Not marketed AU Solution for injection QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA10987/128/002 VPA10987/128/002 Chanonil Combo 134 mg/120.6 mg Spot-on Solution for Medium Dogs Chanelle Pharmaceuticals Manufacturing Limited 06/04/2018 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10987/128/003 VPA10987/128/003 Chanonil Combo 268 mg/241.2 mg Spot-on Solution for Large Dogs Chanelle Pharmaceuticals Manufacturing Limited 06/04/2018 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10987/128/004 VPA10987/128/004 Chanonil Combo 402 mg/361.8 mg Spot-on Solution for Extra Large Dogs Chanelle Pharmaceuticals Manufacturing Limited 06/04/2018 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10987/127/001 VPA10987/127/001 Chanonil Combo 50 mg/60 mg Spot-on Solution for Cats and Ferrets Chanelle Pharmaceuticals Manufacturing Limited 06/04/2018 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Cats Ferrets Ectoparasiticide VPA10987/128/001 VPA10987/128/001 Chanonil Combo 67 mg/60.3 mg Spot-on Solution for Small Dogs Chanelle Pharmaceuticals Manufacturing Limited 06/04/2018 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10987/132/001 VPA10987/132/001 Chanox Multi 50 mg/ml oral suspension for Piglets, Calves and Lambs Chanelle Pharmaceuticals Manufacturing Limited 24/11/2017 VM Marketed AU Oral suspension QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Cattle Pigs Sheep Coccidiostats VPA10990/041/001 VPA10990/041/001 Chloromed 150 mg/g Oral Powder for Calves Univet Limited 11/12/2009 VM Marketed AU Oral powder QJ01AA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Chlortetracycline hydrochloride Prescription Only Medicine Cattle Antibacterial VPA10990/042/001 VPA10990/042/001 Chloromed 150 mg/g oral powder for pigs Univet Limited 04/02/2011 VM Not marketed AU Oral powder QJ01AA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Chlortetracycline hydrochloride Prescription Only Medicine Pigs Antibacterial VPA10990/040/001 VPA10990/040/001 Chloromed 150 mg/g premix for medicated feeding stuff for calves Univet Limited 11/12/2009 VM Not marketed AU Premix for medicated feeding stuff QJ01AA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Chlortetracycline hydrochloride Prescription Only Medicine Cattle Antibacterial VPA10990/043/001 VPA10990/043/001 Chloromed 150 mg/g premix for medicated feeding stuff for pigs Univet Limited 04/02/2011 VM Not marketed AU Premix for medicated feeding stuff QJ01AA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Chlortetracycline hydrochloride Prescription Only Medicine Pigs Antibacterial VPA10990/053/001 VPA10990/053/001 Chloromed 500 mg/g powder for oral solution for chickens and pigs Univet Limited 22/11/2024 VM Unknown AU Powder for oral solution QJ01AA03 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Chlortetracycline hydrochloride Prescription Only Medicine Chickens Pigs Antibacterial VPA10996/021/001 VPA10996/021/001 Chorulon 1500 IU lyophilisate and solvent for solution for injection Intervet Ireland Limited 01/10/1989 VM Unknown AU Lyophilisate and solvent for solution for injection QG03GA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Chorionic gonadotrophin Prescription Only Medicine Cattle Dogs Horses Hormone VPA10996/011/001 VPA10996/011/001 Chronogest CR 20 mg controlled release vaginal sponge for sheep Intervet Ireland Limited 01/10/1987 VM Unknown AU Medicated sponge QG03D Full application (Article 12(3) of Directive No 2001/82/EC) Vaginal use Flugestone acetate Prescription Only Medicine Sheep Hormone VPA10387/006/001 VPA10387/006/001 CIDR 1.38 g Vaginal Delivery System for Cattle Zoetis Belgium S.A. 07/02/2014 VM Unknown AU Vaginal delivery system QG03DA04 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Vaginal use Progesterone Prescription Only Medicine Cattle Hormone VPA10786/005/002 VPA10786/005/002 Citramox 1000 mg/g powder for use in drinking water for chickens, ducks, turkeys and pigs Laboratorios Karizoo S.A. 15/07/2016 VM Unknown AU Powder for use in drinking water QJ01CA04 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Amoxicillin trihydrate Prescription Only Medicine Chickens Duck Pigs Turkeys Antibacterial VPA10786/005/001 VPA10786/005/001 Citramox 500 mg/g powder for use in drinking water for chickens, turkeys, ducks and pigs Laboratorios Karizoo S.A. 29/08/2014 VM Marketed AU Powder for use in drinking water QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin Prescription Only Medicine Chickens Duck Pigs Turkeys Antibacterial VPA10786/006/001 VPA10786/006/001 CITRAMOX L.A. 150 mg/ml suspension for injection for cattle and pigs Laboratorios Karizoo S.A. 09/10/2020 VM Unknown AU Suspension for injection QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Amoxicillin trihydrate Prescription Only Medicine Cattle Pigs Antibacterial VPA10774/071/002 VPA10774/071/002 Clamaden 200 mg/50 mg chewable tablets for cats and dogs Krka, d.d., Novo mesto 18/06/2021 VM Unknown AU Chewable tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA10774/071/001 VPA10774/071/001 Clamaden 40 mg/10 mg chewable tablets for cats and dogs Krka, d.d., Novo mesto 18/06/2021 VM Unknown AU Chewable tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA10774/071/003 VPA10774/071/003 Clamaden 400 mg/100 mg chewable tablets for dogs Krka, d.d., Novo mesto 18/06/2021 VM Unknown AU Chewable tablet QJ01CR02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Dogs Antibacterial VPA10521/029/002 VPA10521/029/002 Clavaseptin 250 mg palatable tablets for dogs Vetoquinol S.A. 21/10/2005 VM Unknown AU Tablet QJ01CR02 Not Currently Available Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Dogs Antibacterial VPA10521/029/001 VPA10521/029/001 Clavaseptin 50 mg palatable tablets for dogs and cats Vetoquinol S.A. 21/10/2005 VM Unknown AU Tablet QJ01CR02 Not Currently Available Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Cats Dogs Antibacterial VPA10521/029/003 VPA10521/029/003 Clavaseptin 500 mg palatable tablets for dogs Vetoquinol S.A. 21/10/2005 VM Unknown AU Tablet QJ01CR02 Not Currently Available Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Dogs Antibacterial VPA10521/029/004 VPA10521/029/004 Clavaseptin 62.5 mg Palatable tablets for dogs and cats Vetoquinol S.A. 26/04/2013 VM Unknown AU Tablet QJ01CR02 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Cats Dogs Antibacterial VPA10521/029/005 VPA10521/029/005 Clavaseptin 750 mg palatable tablets for dogs Vetoquinol S.A. 08/04/2022 VM Unknown AU Tablet QJ01CR02 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate Clavulanic acid Prescription Only Medicine Dogs Antibacterial VPA10817/002/002 VPA10817/002/002 Clavucill 200mg/50mg, tablets for dogs V.M.D. 22/05/2015 VM Unknown AU Tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Dogs Antibacterial VPA10817/002/001 VPA10817/002/001 Clavucill 40mg/10mg, tablets for dogs and cats V.M.D. 22/05/2015 VM Unknown AU Tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA22622/005/002 VPA22622/005/002 Clavudale 200 mg/50 mg tablets for dogs Dechra Regulatory B.V. 15/04/2011 VM Unknown AU Tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Dogs Antibacterial VPA22622/005/001 VPA22622/005/001 Clavudale 40 mg/10 mg tablets for cats and dogs Dechra Regulatory B.V. 28/10/2011 VM Unknown AU Tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use potassium clavulanate Amoxicillin Prescription Only Medicine Cats Dogs Antibacterial VPA22622/005/003 VPA22622/005/003 Clavudale 400 mg/100 mg tablets for dogs Dechra Regulatory B.V. 15/04/2011 VM Unknown AU Tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Dogs Antibacterial VPA10980/026/002 VPA10980/026/002 Clavusan 250 mg + 62.5 mg tablets for dogs and cats Alfasan Nederland B.V. 14/04/2023 VM Unknown AU Tablet QJ01CR02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA10980/026/001 VPA10980/026/001 Clavusan 50 mg + 12.5 mg tablets for dogs and cats Alfasan Nederland B.V. 14/04/2023 VM Unknown AU Tablet QJ01CR02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA10980/026/003 VPA10980/026/003 Clavusan 500 mg + 125 mg tablets for dogs Alfasan Nederland B.V. 14/04/2023 VM Unknown AU Tablet QJ01CR02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Dogs Antibacterial VPA22020/021/001 VPA22020/021/001 CLIK 50 mg/ml Pour-on Suspension for Sheep Elanco GmbH 17/06/2016 VM Unknown AU Pour-on suspension QP53AX24 Full application (Article 12(3) of Directive No 2001/82/EC) Pour-on use Dicyclanil Prescription Only Medicine Sheep Ectoparasiticide VPA22020/022/001 VPA22020/022/001 CLiK Extra 65 mg/ml Pour-On Suspension for Sheep Elanco GmbH 25/11/2016 VM Unknown AU Pour-on suspension QP53AX24 Full application (Article 12(3) of Directive No 2001/82/EC) Pour-on use Dicyclanil Prescription Only Medicine Sheep Ectoparasiticide VPA22020/023/001 VPA22020/023/001 CLiKZiN 12.5 mg/ml Pour-On Suspension for Sheep Elanco GmbH 17/06/2016 VM Unknown AU Pour-on suspension QP53AX24 Full application (Article 12(3) of Directive No 2001/82/EC) Pour-on use Dicyclanil Prescription Only Medicine Sheep Ectoparasiticide VPA10987/144/003 VPA10987/144/003 Clinacin 150 mg Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 26/11/1999 VM Not marketed AU Tablet QJ01FF01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA10987/144/002 VPA10987/144/002 Clinacin 25 mg Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 29/10/1999 VM Not marketed AU Tablet QJ01FF01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA10987/144/005 VPA10987/144/005 Clinacin 300 mg Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 01/06/2007 VM Not marketed AU Tablet QJ01FF01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA10987/144/001 VPA10987/144/001 Clinacin 75 mg Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 22/01/1999 VM Not marketed AU Tablet QJ01FF01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA22622/028/001 VPA22622/028/001 Clindabactin 220 mg chewable tablets for dogs Dechra Regulatory B.V. 18/04/2019 VM AU Chewable tablet QJ01FF01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Clindamycin Prescription Only Medicine Dogs Antibacterial VPA22622/028/002 VPA22622/028/002 Clindabactin 440 mg chewable tablets for dogs Dechra Regulatory B.V. 18/04/2019 VM AU Chewable tablet QJ01FF01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Clindamycin Prescription Only Medicine Dogs Antibacterial VPA22622/027/001 VPA22622/027/001 Clindabactin 55 mg chewable tablets for dogs and cats Dechra Regulatory B.V. 18/04/2019 VM AU Chewable tablet QJ01FF01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Clindamycin Prescription Only Medicine Cats Dogs Antibacterial VPA22622/031/001 VPA22622/031/001 Clindacutin 10 mg/g ointment for dogs Dechra Regulatory B.V. 16/04/2021 VM Unknown AU Ointment QD06AX Hybrid application (Article 13(3) of Directive No 2001/82/EC) Cutaneous use Clindamycin Prescription Only Medicine Dogs Antibacterial VPA10983/049/003 VPA10983/049/003 Clindacyl 150 mg Tablets for Dogs Vetoquinol Ireland Limited 01/09/2000 VM Unknown AU Tablet QJ01FF01 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA10983/049/001 VPA10983/049/001 Clindacyl 25 mg Tablets for dogs and cats Vetoquinol Ireland Limited 01/09/2000 VM Unknown AU Tablet QJ01FF01 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Cats Dogs Antibacterial VPA10987/161/001 VPA10987/161/001 Clindacyl 300 mg Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 30/07/2008 VM Unknown AU Tablet QJ01FF01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Clindamycin (as clindamycin hydrochloride) Prescription Only Medicine Dogs Antibacterial VPA10983/049/002 VPA10983/049/002 Clindacyl 75 mg Tablets for dogs Vetoquinol Ireland Limited 01/09/2000 VM Unknown AU Tablet QJ01FF01 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA10987/163/003 VPA10987/163/003 Clindaseptin 150 mg capsules for dogs Chanelle Pharmaceuticals Manufacturing Limited 28/06/2013 VM Unknown AU Capsule, hard QJ01FF01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA10987/097/001 VPA10987/097/001 Clindaseptin 25 mg/ml oral solution for cats and dogs Chanelle Pharmaceuticals Manufacturing Limited 25/05/2012 VM Unknown AU Oral solution QJ01FF01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Clindamycin Prescription Only Medicine Cats Dogs Antibacterial VPA10987/163/001 VPA10987/163/001 Clindaseptin 25 mg capsules for dogs Chanelle Pharmaceuticals Manufacturing Limited 18/07/2014 VM Not marketed AU Capsule, hard QJ01FF01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA10987/163/004 VPA10987/163/004 Clindaseptin 300 mg capsules for dogs Chanelle Pharmaceuticals Manufacturing Limited 28/06/2013 VM Unknown AU Capsule, hard QJ01FF01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA10987/163/002 VPA10987/163/002 Clindaseptin 75 mg capsules for dogs Chanelle Pharmaceuticals Manufacturing Limited 28/06/2013 VM Unknown AU Capsule, hard QJ01FF01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Clindamycin hydrochloride Prescription Only Medicine Dogs Antibacterial VPA22664/084/001 VPA22664/084/001 Closamectin 5 mg/ml/125 mg/ml Solution for Injection for Sheep Norbrook Laboratories (Ireland) Limited 25/04/2008 VM Unknown AU Solution for injection QP54AA51 Fixed combination application (Article 13b of Directive No 2001/82/EC) Subcutaneous use Ivermectin Closantel sodium dihydrate Prescription Only Medicine Sheep Endectoparasiticides VPA22664/088/001 VPA22664/088/001 Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle Norbrook Laboratories (Ireland) Limited 07/08/2009 VM Unknown AU Pour-on solution QP54AA51 Full application (Article 12(3) of Directive No 2001/82/EC) Pour-on use Ivermectin Closantel sodium Prescription Only Medicine Cattle Endectoparasiticides VPA22664/083/001 VPA22664/083/001 Closamectin Solution for Injection for Cattle Norbrook Laboratories (Ireland) Limited 09/11/2007 VM Unknown AU Solution for injection QP54AA51 Fixed combination application (Article 13b of Directive No 2001/82/EC) Subcutaneous use Ivermectin Closantel sodium dihydrate Prescription Only Medicine Cattle Endectoparasiticides VPA22664/102/001 VPA22664/102/001 Closivet 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle Norbrook Laboratories (Ireland) Limited 25/05/2012 VM Unknown AU Pour-on solution QP54AA51 Informed consent application (Article 13c of Directive No 2001/82/EC) Pour-on use Ivermectin Closantel sodium dihydrate Prescription Only Medicine Cattle Endectoparasiticides VPA10981/001/001 VPA10981/001/001 Co-Trimoxazole 240 mg/ml solution for injection for cattle. Kela n.v. 01/10/1988 VM Unknown AU Solution for injection QJ01EW11 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Sulfamethoxazole Trimethoprim Prescription Only Medicine Cattle Antibacterial VPA10996/104/001 VPA10996/104/001 Cobactan 25 mg/ml suspension for injection for cattle and pigs Intervet Ireland Limited 20/09/1995 VM Unknown AU Suspension for injection QJ01DE90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Cefquinome sulfate Prescription Only Medicine Cattle Pigs Antibacterial VPA10996/105/001 VPA10996/105/001 Cobactan LC, 75 mg, intramammary ointment for lactating cattle Intervet Ireland Limited 29/05/1998 VM Unknown AU Intramammary ointment QJ51DE90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use Cefquinome sulfate Prescription Only Medicine Cattle Antibacterial VPA10987/032/001 VPA10987/032/001 Cobalt Super 2.1 mg/ml oral solution Chanelle Pharmaceuticals Manufacturing Limited 01/10/1989 VM Unknown AU Oral solution QV06D Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Cobalt sulphate heptahydrate Licensed Retailer Cattle Sheep Vitamins and minerals VPA10790/012/002 VPA10790/012/002 Coccibal 400 mg/ml solution for use in drinking water for chickens and turkeys SP Veterinaria, S.A. 26/02/2021 VM Unknown AU Solution for use in drinking water QP51BX02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Amprolium hydrochloride Prescription Only Medicine Chickens Turkeys Coccidiostats VPA10790/012/001 VPA10790/012/001 Coccibal, 200 mg/ml solution for use in drinking water for chickens and turkeys SP Veterinaria, S.A. 16/02/2017 VM Unknown AU Oral solution QP51AX09 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Amprolium hydrochloride Prescription Only Medicine Chickens Turkeys Coccidiostats VPA10782/047/001 VPA10782/047/001 Cocciril 2.5 mg/ml oral suspension for cattle and sheep Huvepharma NV 30/05/2025 VM Unknown AU Oral suspension QP51BC03 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Diclazuril Prescription Only Medicine Cattle Sheep Coccidiostats VPA10815/030/001 VPA10815/030/001 Coglapix suspension for injection for pigs. Ceva Santé Animale 23/10/2015 VM Unknown AU Suspension for injection QI09AB07 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Actinobacillus pleuropneumoniae strain nt3 Actinobacillus pleurpneumoniae strain szii Actinobacillus pleuropneumoniae strain po Actinobacillus pleuropneumoniae strain u3 Actinobacillus pleuropneumoniae strain b4 Prescription Only Exempt Pigs Immunological - Inactivated Vaccine VPA10387/007/001 VPA10387/007/001 Colombovac PMV suspension for injection Zoetis Belgium S.A. 24/11/2014 VM Unknown AU Suspension for injection QI01EA01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Inactivated newcastle disease virus strain la sota Prescription Only Exempt Pigeons Immunological - Inactivated Vaccine VPA22664/028/001 VPA22664/028/001 Colvasone 2 mg/ml Solution for injection Norbrook Laboratories (Ireland) Limited 01/10/1989 VM Unknown AU Solution for injection QH02AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Horses Corticosteroid VPA22664/143/001 VPA22664/143/001 Combiclav Intramammary Suspension for Lactating Cows Norbrook Laboratories (Ireland) Limited 23/11/2018 VM AU Intramammary suspension QJ51RV01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Amoxicillin trihydrate potassium clavulanate Prednisolone Prescription Only Medicine Cattle Antibacterial VPA10989/069/001 VPA10989/069/001 Comfortan 10 mg/ml solution for injection for dogs and cats Eurovet Animal Health B.V. 14/10/2016 VM Unknown AU Solution for injection QN02AC90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Methadone hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10836/008/001 VPA10836/008/001 CONTINENCE 40 mg/ml syrup for dogs FATRO S.p.A. 11/10/2019 VM Marketed AU Syrup QG04BX91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Phenylpropanolamine hydrochloride Prescription Only Medicine Dogs Miscellaneous VPA10956/005/002 VPA10956/005/002 Copper 20 mg/ml Suspension for Injection Ballinskelligs Vet. Products Ltd 01/10/1991 VM Unknown AU Suspension for injection QA12CX Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Copper methionate Licensed Retailer Cattle Sheep Vitamins and minerals VPA10495/005/001 VPA10495/005/001 CORTEXONAVET 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats Laboratorios Syva S.A. 05/02/2016 VM Marketed AU Solution for injection QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intraarticular use Intramuscular use Intravenous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Horses Pigs Corticosteroid VPA10539/006/001 VPA10539/006/001 Cortico Veyxin 10 mg/ml suspension for injection for cattle, horses, dogs and cats Veyx-Pharma GmbH 21/09/2018 VM Unknown AU Suspension for injection QH02AB06 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Prednisolone acetate Prescription Only Medicine Cats Cattle Dogs Horses Corticosteroid VPA10988/117/001 VPA10988/117/001 Cortotic 0.584 mg/ml ear spray, solution for dogs Virbac 17/02/2023 VM Unknown AU Ear spray, solution QS02BA01 Full application (Article 12(3) of Directive No 2001/82/EC) Auricular use Hydrocortisone Aceponate Prescription Only Medicine Dogs Corticosteroid VPA22622/001/001 VPA22622/001/001 Cosacthen 0.25 mg/ml solution for injection for dogs Dechra Regulatory B.V. 14/02/2020 VM Unknown AU Solution for injection QH01AA02 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramuscular use Intravenous use Tetracosactide hexaacetate Prescription Only Medicine Dogs Hormone VPA22033/054/001 VPA22033/054/001 Cosecure Cattle Bolus Continuous Release Intraruminal Device Bimeda Animal Health Limited 27/04/2005 VM Marketed AU Continuous-release intraruminal device QA12CE99 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Copper Cobalt Sodium selenate Licensed Retailer Cattle Vitamins and minerals VPA10387/008/001 VPA10387/008/001 Covexin 10 Suspension for injection for sheep and cattle Zoetis Belgium S.A. 09/12/2013 VM Marketed AU Suspension for injection QI02AB01 QI04AB01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use C. haemolyticum toxoid (strain cn 3629) C. sordellii toxoid (strain 831) C. tetani toxoid (strain cn 3911) C. septicum toxoid (strain cn 368) C. novyi type b toxoid (strain cn 6120) C. chauvoei whole culture (strain cn 3796) C. perfringens type a toxoid (strain cn 1491) C. perfringens type b toxoid (strain cn 1240) C. perfringens type c toxoid (strain cn 883) C. perfringens type d toxoid (strain cn 3688) Licensed Retailer Cattle Sheep Immunological - Inactivated Vaccine VPA10387/009/001 VPA10387/009/001 Covexin 8 suspension for injection for sheep and cattle Zoetis Belgium S.A. 11/07/2014 VM Unknown AU Suspension for injection QI02AB01 QI04AB01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use C. perfringens type b & c ß toxoid C. perfringens type d (e) toxoid Clostridium chauvoei, strain 3796, Inactivated C. novyi type B anaculture C. septicum toxoid C. tetani toxoid C. haemolyticum anaculture Licensed Retailer Cattle Sheep Immunological - Inactivated Vaccine VPA10774/008/001 VPA10774/008/001 Coxaclear 50 mg/ml oral suspension for pigs, cattle and sheep Krka, d.d., Novo mesto 24/09/2010 VM Not marketed AU Oral suspension QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Cattle Pigs Sheep Coccidiostats VPA10483/002/001 VPA10483/002/001 Coxx-Kure 50 mg/ml oral suspension for piglets and calves LAPROVET 05/01/2015 VM Unknown AU Oral suspension QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Cattle Pigs Coccidiostats VPA22033/034/001 VPA22033/034/001 Cronyxin 50 mg/g Oral paste for horses Bimeda Animal Health Limited 16/11/2018 VM AU Oral paste QM01AG90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Flunixin Prescription Only Medicine Horses N.S.A.I.D. VPA22033/040/001 VPA22033/040/001 Cronyxin Injection 50 mg/ml Solution for Injection Bimeda Animal Health Limited 20/02/1996 VM Unknown AU Solution for injection QM01AG90 Informed consent (abridged application) - Council Directive 81/851/EEC Intravenous use Intramuscular use Flunixin meglumine Prescription Only Medicine Cattle Horses N.S.A.I.D. VPA10509/023/001 VPA10509/023/001 Cryptisel 0.5 mg/ml oral solution for calves Industrial Veterinaria S.A. 13/11/2020 VM Marketed AU Oral solution QP51AX08 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Halofuginone Lactate Prescription Only Medicine Cattle Coccidiostats VPA10990/018/001 VPA10990/018/001 CTC 10 %w/w Oral Powder Univet Limited 01/10/1988 VM Unknown AU Oral powder QJ01AA03 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Chlortetracycline hydrochloride Prescription Only Medicine Cattle Pigs Antibacterial VPA10990/039/001 VPA10990/039/001 CTC 10 %w/w Premix for Medicated Feed Univet Limited 23/06/2006 VM Unknown AU Premix for medicated feeding stuff QJ01AA03 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Chlortetracycline hydrochloride Prescription Only Medicine Cattle Pigs Antibacterial VPA10990/039/002 VPA10990/039/002 CTC 15 %w/w Premix for Medicated Feed Univet Limited 23/06/2006 VM Unknown AU Premix for medicated feeding stuff QJ01AA03 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Chlortetracycline hydrochloride Prescription Only Medicine Cattle Pigs Antibacterial VPA10990/034/001 VPA10990/034/001 CTC 15% w/w Oral Powder Univet Limited 19/02/1999 VM Not marketed AU Oral powder QJ01AA03 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Chlortetracycline hydrochloride Prescription Only Medicine Cattle Pigs Antibacterial VPA10791/024/001 VPA10791/024/001 Cubarmix Equi 400 mg/g and 80 mg/g oral powder for horses Dopharma Research B.V. 23/01/2026 VM Unknown AU Oral powder QJ01EW10 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Sulfadiazine Trimethoprim Prescription Only Medicine Horses Antibacterial VPA10988/092/001 VPA10988/092/001 Curacef duo, 50 mg/ml/150 mg/ml, Suspension for Injection for Cattle Virbac 01/08/2014 VM Unknown AU Suspension for injection QJ01DD Fixed combination application (Article 13b of Directive No 2001/82/EC) Intramuscular use Ceftiofur hydrochloride Ketoprofen Prescription Only Medicine Cattle Antibacterial VPA10990/032/002 VPA10990/032/002 Curafluke 10% w/v Oral Drench Univet Limited 15/09/2000 VM Unknown AU Oral suspension QP52AC30 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Fenbendazole Rafoxanide Prescription Only Medicine Cattle Endoparasiticide VPA10990/032/001 VPA10990/032/001 Curafluke 50 mg/ml oral drench for cattle and sheep Univet Limited 05/09/1997 VM Unknown AU Oral suspension QP52AC30 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Fenbendazole Rafoxanide Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10990/015/001 VPA10990/015/001 Curazole 100 mg/ml oral drench for cattle Univet Limited 07/05/1991 VM Unknown AU Oral suspension QP52AC13 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Fenbendazole Prescription Only Medicine Cattle Endoparasiticide VPA10990/015/004 VPA10990/015/004 Curazole 100 mg/ml oral suspension for horses Univet Limited 23/12/2022 VM Unknown AU Oral suspension QP52AC13 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Fenbendazole Prescription Only Medicine Horses Endoparasiticide VPA10990/015/002 VPA10990/015/002 Curazole 25 mg/ml oral drench for sheep Univet Limited 14/05/1992 VM Not marketed AU Oral suspension QP52AC13 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Fenbendazole Prescription Only Medicine Sheep Endoparasiticide VPA10990/030/001 VPA10990/030/001 Curazole 5% w/w Premix for Medicated Feed Univet Limited 26/06/1998 VM Unknown AU Premix for medicated feeding stuff QP52AC13 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Fenbendazole Prescription Only Medicine Pigs Endoparasiticide VPA10990/044/001 VPA10990/044/001 Curazole 50 mg/g oral powder for pigs Univet Limited 29/07/2011 VM Unknown AU Oral powder QP52AC13 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Fenbendazole Prescription Only Medicine Pigs Endoparasiticide VPA10990/015/003 VPA10990/015/003 Curazole 50 mg/ml oral drench for cattle and sheep Univet Limited 12/03/1992 VM Unknown AU Oral suspension QP52AC13 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Fenbendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10990/045/001 VPA10990/045/001 Curofen 50 mg/g oral powder for pigs Univet Limited 06/11/2015 VM Not marketed AU Oral powder QP52AC13 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Fenbendazole Prescription Only Medicine Pigs Endoparasiticide VPA10990/046/001 VPA10990/046/001 Curofen 50 mg/g Premix for Medicated Feeding Stuff for Pigs Univet Limited 08/09/2017 VM Unknown AU Premix for medicated feeding stuff QP52AC13 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Fenbendazole Prescription Only Medicine Pigs Endoparasiticide VPA10988/094/001 VPA10988/094/001 Cyclavance 100 mg/ml oral solution for dogs and cats Virbac 14/03/2014 VM Marketed AU Oral solution QL04A Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Ciclosporin Prescription Only Medicine Cats Dogs Miscellaneous VPA10988/061/001 VPA10988/061/001 Cyclio 12 mg Spot-on Solution For Small Dogs Virbac S.A. 15/09/2000 VM Unknown AU Spot-on solution QP53AX23 Not Currently Available Spot-on use Pyriproxyfen Prescription Only Medicine Dogs Ectoparasiticide VPA10988/061/002 VPA10988/061/002 Cyclio 30 mg Spot-on Solution for Medium Sized Dogs Virbac S.A. 15/09/2000 VM Unknown AU Spot-on solution QP53AX23 Not Currently Available Spot-on use Pyriproxyfen Prescription Only Medicine Dogs Ectoparasiticide VPA10988/061/003 VPA10988/061/003 Cyclio 60 mg Spot-on Solution for Large Dogs Virbac S.A. 15/09/2000 VM Unknown AU Spot-on solution QP53AX23 Not Currently Available Spot-on use Pyriproxyfen Prescription Only Medicine Dogs Ectoparasiticide VPA10988/079/001 VPA10988/079/001 Cyclix 250 microgram/ml solution for injection for cattle Virbac 28/11/2008 VM Unknown AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cloprostenol sodium Prescription Only Medicine Cattle Hormone VPA10988/080/001 VPA10988/080/001 Cyclix porcine 87.5 microgram/ml solution for injection Virbac 28/11/2008 VM Unknown AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cloprostenol sodium Prescription Only Medicine Pigs Hormone VPA22622/040/001 VPA22622/040/001 Cyclofin 300 mg/ml + 20 mg/ml solution for injection for cattle Dechra Regulatory B.V. 15/09/2023 VM Unknown AU Solution for injection QJ01AA56 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Oxytetracycline Flunixin Prescription Only Medicine Cattle Antibacterial VPA10989/026/001 VPA10989/026/001 Cyclosol LA 200 mg/ml solution for injection for cattle and pigs. Eurovet Animal Health B.V. 01/10/1988 VM Unknown AU Solution for injection QJ01AA06 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Oxytetracycline dihydrate Prescription Only Medicine Cattle Pigs Antibacterial VPA10989/049/001 VPA10989/049/001 Cyclospray, 2.45 % w/w cutaneous spray, suspension for cattle, sheep and pigs Eurovet Animal Health B.V. 23/03/2001 VM Unknown AU Cutaneous spray, suspension QD06A Not Currently Available Topical use Chlortetracycline hydrochloride Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10387/011/001 VPA10387/011/001 Cydectin 0.1% w/v oral solution for sheep Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Oral solution QP54AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Moxidectin Prescription Only Medicine Sheep Endectoparasiticides VPA10387/012/001 VPA10387/012/001 CYDECTIN 0.5% w/v Pour-On for cattle Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Pour-on solution QP54AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Pour-on use Moxidectin Prescription Only Medicine Cattle Endectoparasiticides VPA10387/013/001 VPA10387/013/001 Cydectin 1 % w/v Solution for injection for cattle Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Solution for injection QP54AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Moxidectin Prescription Only Medicine Cattle Endectoparasiticides VPA10387/014/001 VPA10387/014/001 Cydectin 1% w/v Injectable Solution for Sheep Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Solution for injection QP54AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Moxidectin Prescription Only Medicine Sheep Endectoparasiticides VPA10387/015/001 VPA10387/015/001 Cydectin 10 % LA Solution for Injection for Cattle Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Solution for injection QP54AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Moxidectin Prescription Only Medicine Cattle Endectoparasiticides VPA10387/095/001 VPA10387/095/001 Cydectin LA 20 mg/ml Solution for Injection for Sheep Zoetis Belgium S.A. 24/05/2019 VM Unknown AU Solution for injection QP54AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Moxidectin Prescription Only Medicine Sheep Endectoparasiticides VPA10387/016/001 VPA10387/016/001 Cydectin TriclaMox 1mg/ml + 50 mg/ml Oral Solution for sheep Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Oral solution QP54AB52 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Moxidectin Triclabendazole Prescription Only Medicine Sheep Endectoparasiticides VPA10387/017/001 VPA10387/017/001 Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for cattle Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Pour-on solution QP54AB52 Fixed combination application (Article 13b of Directive No 2001/82/EC) Cutaneous use Moxidectin Triclabendazole Prescription Only Medicine Cattle Endectoparasiticides VPA10509/025/002 VPA10509/025/002 Cylanic 250 mg + 62.5 mg tablets for dogs and cats Industrial Veterinaria S.A. 28/05/2021 VM Unknown AU Tablet QJ01CR02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA10509/025/001 VPA10509/025/001 Cylanic 50 mg + 12.5 mg tablets for dogs and cats Industrial Veterinaria S.A. 28/05/2021 VM Unknown AU Tablet QJ01CR02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA10509/025/003 VPA10509/025/003 Cylanic 500 mg + 125 mg tablets for dogs Industrial Veterinaria S.A. 28/05/2021 VM Unknown AU Tablet QJ01CR02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Dogs Antibacterial VPA22033/081/001 VPA22033/081/001 Cypercare 2.5%w/v Pour-on Solution Bimeda Animal Health Limited 14/06/1996 VM Unknown AU Pour-on solution QP53AC08 Complete application (stand-alone) - Council Directive 81/851/EEC Pour-on use Cypermethrin technical (93%) (cis: trans 50:50) Prescription Only Medicine Cattle Ectoparasiticide VPA22033/007/001 VPA22033/007/001 Cyperguard Concentrate for Dip Emulsion Bimeda Animal Health Limited 15/05/1998 VM Unknown AU Concentrate for dip emulsion QP53AC08 Informed consent application (Article 13c of Directive No 2001/82/EC) Cutaneous use Cypermethrin (Cis:Trans 80:20) Prescription Only Medicine Sheep Ectoparasiticide VPA10784/001/001 VPA10784/001/001 CZV Avian Tuberculin PPD CZ Vaccines S.A.U. 06/07/2007 VM Not marketed AU Solution for injection QI02AR02 Full application (Article 12(3) of Directive No 2001/82/EC) Intradermal use Purified protein derivative from culture of Mycobacterium avium, subsp. avium strain D4 ER Prescription Only Medicine Cattle Immunological VPA10784/002/001 VPA10784/002/001 CZV BOVINE TUBERCULIN PPD, solution for injection CZ Vaccines S.A.U. 28/10/2011 VM Not marketed AU Solution for injection QI02AR01 Full application (Article 12(3) of Directive No 2001/82/EC) Intradermal use Purified protein derivative from culture of mycobacterium bovis, strain an-5 Prescription Only Medicine Cattle Immunological VPA10774/074/003 VPA10774/074/003 DACLOTRIX 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg Krka, d.d., Novo mesto 01/04/2022 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin (Cis:Trans 40:60) Imidacloprid for veterinary use Prescription Only Medicine Dogs Ectoparasiticide VPA10774/074/001 VPA10774/074/001 DACLOTRIX 200 mg/40 mg spot-on solution for dogs up to 4 kg Krka, d.d., Novo mesto 01/04/2022 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin (Cis:Trans 40:60) Imidacloprid for veterinary use Prescription Only Medicine Dogs Ectoparasiticide VPA10774/074/004 VPA10774/074/004 DACLOTRIX 2000 mg/400 mg spot-on solution for dogs over 25 kg Krka, d.d., Novo mesto 01/04/2022 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin (Cis:Trans 40:60) Imidacloprid for veterinary use Prescription Only Medicine Dogs Ectoparasiticide VPA10774/074/002 VPA10774/074/002 DACLOTRIX 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg Krka, d.d., Novo mesto 01/04/2022 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin (Cis:Trans 40:60) Imidacloprid for veterinary use Prescription Only Medicine Dogs Ectoparasiticide VPA10836/009/001 VPA10836/009/001 Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses FATRO S.p.A. 13/09/2019 VM AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use D-cloprostenol sodium salt Prescription Only Medicine Cattle Horses Pigs Hormone VPA10836/002/001 VPA10836/002/001 Dalmarelin 25 micrograms/ml solution for injection for cattle and rabbits FATRO S.p.A. 19/03/2004 VM Unknown AU Solution for injection QH01CA92 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Lecirelin acetate Prescription Only Medicine Cattle Rabbits Hormone VPA10836/001/001 VPA10836/001/001 Dalmazin, 75 micrograms/ml, solution for injection for cattle, buffaloes and pigs FATRO S.p.A. 13/10/2000 VM *** AWAITING VALUE *** AU Solution for injection QG02AD90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use D-cloprostenol sodium salt Prescription Only Medicine Buffalo Cattle Pigs Hormone VPA10774/073/003 VPA10774/073/003 Damtix 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg Krka, d.d., Novo mesto 01/04/2022 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin (Cis:Trans 40:60) Imidacloprid for veterinary use Prescription Only Medicine Dogs Ectoparasiticide VPA10774/073/001 VPA10774/073/001 Damtix 200 mg/40 mg spot-on solution for dogs up to 4 kg Krka, d.d., Novo mesto 01/04/2022 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin (Cis:Trans 40:60) Imidacloprid for veterinary use Prescription Only Medicine Dogs Ectoparasiticide VPA10774/073/004 VPA10774/073/004 Damtix 2000 mg/400 mg spot-on solution for dogs over 25 kg Krka, d.d., Novo mesto 01/04/2022 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Permethrin (Cis:Trans 40:60) Imidacloprid for veterinary use Prescription Only Medicine Dogs Ectoparasiticide VPA10774/073/002 VPA10774/073/002 Damtix 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg Krka, d.d., Novo mesto 01/04/2022 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid for veterinary use Permethrin (Cis:Trans 40:60) Prescription Only Medicine Dogs Ectoparasiticide VPA10491/014/001 VPA10491/014/001 Danilon Equidos NF 1.5 g/sachet granules in sachet for horses and ponies Ecuphar N.V. 10/05/2024 VM Unknown AU Granules in sachet QM01AA90 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Suxibuzone Prescription Only Medicine Horse (non-food producing) N.S.A.I.D. VPA25497/002/001 VPA25497/002/001 Deccox 60.6 g/kg Premix for Medicated Feeding Stuff Phibro Animal Health (Poland) Sp. z o.o. 01/10/1989 VM Unknown AU Premix for medicated feeding stuff QP51AX14 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Decoquinate Prescription Only Medicine Cattle Sheep Coccidiostats VPA10387/019/001 VPA10387/019/001 DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Zoetis Belgium S.A. 09/12/2012 VM Unknown AU Solution for injection QP54AA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Doramectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA10387/020/001 VPA10387/020/001 Dectomax 5 mg/ml Pour-On Solution for Cattle Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Pour-on solution QP54AA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Doramectin Prescription Only Medicine Cattle Endectoparasiticides VPA22033/058/001 VPA22033/058/001 Dectospot 10 mg/ml Pour-on Solution for Cattle and Sheep Bimeda Animal Health Limited 12/02/2016 VM Unknown AU Pour-on solution QP53AC11 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Deltamethrin Prescription Only Medicine Cattle Sheep Ectoparasiticide VPA10988/053/001 VPA10988/053/001 Defendog Cutaneous solution Virbac S.A. 13/06/1997 VM Unknown AU Cutaneous solution QP53AC04 Complete application (stand-alone) - Council Directive 81/851/EEC Cutaneous use Permethrin (Cis:Trans 40:60) Companion Animal Medicine Dogs Ectoparasiticide VPA22033/008/001 VPA22033/008/001 Deltadot 10 mg/ml Pour-on Solution for Cattle and Sheep Bimeda Animal Health Limited 23/09/2016 VM Unknown AU Pour-on solution QP53AC11 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Deltamethrin Prescription Only Medicine Cattle Sheep Ectoparasiticide VPA10988/087/001 VPA10988/087/001 Deltanil 10 mg/ml Pour-on Solution for cattle and sheep Virbac 28/03/2014 VM Unknown AU Pour-on solution QP53AC11 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Pour-on use Deltamethrin Prescription Only Medicine Cattle Sheep Ectoparasiticide VPA10387/021/001 VPA10387/021/001 Depo-Medrone V 40 mg/ml Suspension for Injection Zoetis Belgium S.A. 06/01/2014 VM Unknown AU Suspension for injection QH02AB04 Full application (Article 12(3) of Directive No 2001/82/EC) Intraarticular use Intramuscular use Methylprednisolone acetate Prescription Only Medicine Cats Dogs Horse (non-food producing) Corticosteroid VPA10996/068/001 VPA10996/068/001 Depocillin 300 mg/ml Suspension for Injection Intervet Ireland Limited 01/10/1987 VM Unknown AU Suspension for injection QJ01CE09 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Subcutaneous use Procaine benzylpenicillin Prescription Only Medicine Cats Cattle Dogs Horses Pigs Sheep Antibacterial VPA10475/026/001 VPA10475/026/001 Dermanolon 1.77 mg/ml + 17.7 mg/ml cutaneous spray, solution for dogs and cats Le Vet Beheer B.V. 10/02/2017 VM Unknown AU Cutaneous spray, solution QD07XB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Triamcinolone acetonide Salicylic acid Prescription Only Medicine Cats Dogs Corticosteroid VPA10815/029/002 VPA10815/029/002 Dermipred 10 mg tablets for dogs Ceva Santé Animale 11/11/2016 VM Unknown AU Tablet QH02AB06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Prednisolone Prescription Only Medicine Dogs Corticosteroid VPA10815/029/003 VPA10815/029/003 Dermipred 20 mg tablets for dogs Ceva Santé Animale 11/11/2016 VM Unknown AU Tablet QH02AB06 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Prednisolone Prescription Only Medicine Dogs Corticosteroid VPA10815/029/001 VPA10815/029/001 Dermipred 5 mg tablets for dogs Ceva Santé Animale 11/11/2016 VM Unknown AU Tablet QH02AB06 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Prednisolone Prescription Only Medicine Dogs Corticosteroid VPA10789/001/001 VPA10789/001/001 DETOGESIC 10 mg/ml Solution for Injection for Horses Vetcare Limited, 22/08/2008 VM Unknown AU Solution for injection QN05CM90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intravenous use Detomidine hydrochloride Prescription Only Medicine Horses Neurological Preparations VPA10816/010/001 VPA10816/010/001 Detonervin 10 mg/ml, solution for injection for Horses and Cattle Le Vet BV 21/01/2011 VM Unknown AU Solution for injection QN05CM90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Detomidine hydrochloride Prescription Only Medicine Cattle Horses Neurological Preparations VPA10791/004/001 VPA10791/004/001 Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats Dopharma Research B.V. 05/10/2012 VM Marketed AU Solution for injection QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intraarticular use Intramuscular use Intravenous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Horses Pigs Corticosteroid VPA10475/035/001 VPA10475/035/001 Dexacortone 0.5 mg chewable tablets for dogs and cats Le Vet Beheer B.V. 05/01/2018 VM Unknown AU Chewable tablet QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Dexamethasone Prescription Only Medicine Cats Dogs Corticosteroid VPA10475/035/002 VPA10475/035/002 Dexacortone 2.0 mg chewable tablets for dogs and cats Le Vet Beheer B.V. 05/01/2018 VM Unknown AU Chewable tablet QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Dexamethasone Prescription Only Medicine Cats Dogs Corticosteroid VPA10996/027/001 VPA10996/027/001 Dexadreson 2 mg/ml solution for injection Intervet Ireland Limited 01/10/1989 VM Marketed AU Solution for injection QH02AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Intraarticular use Intramuscular use Intravenous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Horses Pigs Corticosteroid VPA10509/017/001 VPA10509/017/001 Dexafast 2 mg/ml solution for injection for horses, cattle, goats, pigs, dogs and cats Industrial Veterinaria S.A. 25/01/2019 VM AU Solution for injection QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intraarticular use Intramuscular use Intravenous use Periarticular use Subcutaneous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Corticosteroid VPA10996/028/001 VPA10996/028/001 Dexafort Suspension for Injection Intervet Ireland Limited 01/10/1989 VM Unknown AU Suspension for injection QH02AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Dexamethasone sodium phosphate Dexamethasone phenylpropionate Prescription Only Medicine Cattle Horses Corticosteroid VPA10823/013/001 VPA10823/013/001 Dexameth 2 mg/ml solution for injection Chem-Pharm Limited 01/10/1999 VM AU Solution for injection QH02AB02 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Intravenous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Horses Corticosteroid VPA10980/002/001 VPA10980/002/001 Dexamethasone 2 mg/ml solution for injection for dogs, cats, cattle and horses Alfasan Nederland B.V. 01/10/1989 VM Unknown AU Solution for injection QH02AB02 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Intravenous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Horses Corticosteroid VPA20742/003/001 VPA20742/003/001 DEXASHOT 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats Vet-Agro Multi-Trade Company Sp z o.o. 21/06/2019 VM Unknown AU Solution for injection QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intraarticular use Intramuscular use Intravenous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Horses Pigs Corticosteroid VPA10826/002/001 VPA10826/002/001 Dexatat 2 mg/ml solution for Injection aniMedica GmbH 01/10/1989 VM Marketed AU Solution for injection QH02AB02 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramuscular use Intravenous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Horses Pigs Corticosteroid VPA10980/034/001 VPA10980/034/001 Dexdormostart Alfasan Nederland B.V. 13/10/2023 VM Unknown AU Solution for injection QN05CM18 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Dexmedetomidine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA25237/001/001 VPA25237/001/001 Dexmedocord 0.5 mg/ml solution for injection for dogs and cats Accord Healthcare B.V. 15/11/2024 VM Unknown AU Solution for injection QN05CM18 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Dexmedetomidine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10516/013/001 VPA10516/013/001 DEXMOPET 0.5 mg/ml solution for injection for dogs and cats Vetpharma Animal Health S.L. 26/08/2016 VM Marketed AU Solution for injection QN05CM18 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Dexmedetomidine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA23462/016/001 VPA23462/016/001 Dexrapid 2 mg/ml solution for injection VetViva Richter GmbH 30/10/2020 VM Unknown AU Solution for injection QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intraarticular use Intramuscular use Intravenous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Horses Pigs Corticosteroid VPA10505/001/001 VPA10505/001/001 DFV DOXIVET 200 mg/ml, solution for use in drinking water for pigs and chickens Divasa-Farmavic S.A., 30/09/2011 VM Unknown AU Solution for use in drinking water QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycycline hyclate Prescription Only Medicine Chickens Pigs Antibacterial VPA10505/002/001 VPA10505/002/001 DFV DOXIVET 500 mg/g, powder for use in drinking water for pigs and chickens Divasa-Farmavic S.A., 17/02/2012 VM Unknown AU Powder for use in drinking water QJ01AA02 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Doxycycline hyclate Prescription Only Medicine Chickens Pigs Antibacterial VPA10806/007/001 VPA10806/007/001 DiarrVac RCE Emulsion for injection for cattle. FORTE Healthcare Ltd 08/04/2022 VM Unknown AU Emulsion for injection QI02AL01 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Bovine rotavirus, Inactivated Bovine coronavirus, Inactivated Escherichia Coli (Inactivated) Prescription Only Medicine Cattle Immunological - Inactivated Vaccine VPA10989/070/001 VPA10989/070/001 Diatrim 200 mg/ml + 40 mg/ml solution for injection Eurovet Animal Health B.V. 09/02/2018 VM Unknown AU Solution for injection QJ01EW10 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Sulfadiazine Trimethoprim Prescription Only Medicine Cats Cattle Dogs Pigs Antibacterial VPA23462/008/001 VPA23462/008/001 Diazedor 5 mg/ml solution for injection for dogs and cats VetViva Richter GmbH 01/06/2018 VM Unknown AU Solution for injection QN05BA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Diazepam Prescription Only Medicine Cats Dogs Neurological Preparations VPA23174/003/001 VPA23174/003/001 DIB 1.0 g Vaginal Delivery System for Cattle Syn Vet-Pharma Ireland Limited 04/06/2021 VM Unknown AU Vaginal delivery system QG03DA04 Well-established use application (Article 13a of Directive No 2001/82/EC) Vaginal use Progesterone Prescription Only Medicine Cattle Hormone VPA10786/010/001 VPA10786/010/001 Diclacare 2.5 mg/ml Oral Suspension for lambs and calves Laboratorios Karizoo S.A. 28/03/2024 VM Unknown AU Oral suspension QP51BC03 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Oral use Diclazuril Prescription Only Medicine Cattle Sheep Coccidiostats VPA10980/004/001 VPA10980/004/001 Dihydrostreptomycin 25% Solution for Injection Alfasan Nederland B.V. 01/10/1988 VM Unknown AU Solution for injection QJ01GA90 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Dihydrostreptomycin sulphate Prescription Only Medicine Cattle Antibacterial VPA10475/002/001 VPA10475/002/001 Dilaterol 25 micrograms/ml syrup for horses Le Vet Beheer B.V. 16/11/2012 VM Unknown AU Syrup QR03CC13 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Clenbuterol hydrochloride Prescription Only Medicine Horses Respiratory Tract preparations VPA10996/109/001 VPA10996/109/001 Dimazon 50 mg/ml Solution for Injection Intervet Ireland Limited 01/10/1995 VM Unknown AU Solution for injection QC03CA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Furosemide Monoethanolamine Prescription Only Medicine Cats Cattle Dogs Horses Cardiovascular VPA10389/001/001 VPA10389/001/001 DINALGEN 300 mg/ml oral solution for use in drinking water for cattle and pigs Ecuphar Veterinaria S.L.U. 08/04/2009 VM Unknown AU Oral solution QM01AE03 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Ketoprofen Prescription Only Medicine Cattle Pigs N.S.A.I.D. VPA10389/002/001 VPA10389/002/001 DINALGEN 150 mg/ml solution for injection for cattle, pigs and horses Ecuphar Veterinaria S.L.U. 24/09/2010 VM Marketed AU Solution for injection QM01AE03 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA22033/009/001 VPA22033/009/001 Dipen 100ml Suspension for Injection for cattle, sheep and pigs Bimeda Animal Health Limited 03/03/2006 VM Unknown AU Suspension for injection QJ01RA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Procaine benzylpenicillin Dihydrostreptomycin sulfate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10791/013/001 VPA10791/013/001 Distocur 34 mg/ml Oral suspension for cattle and sheep Dopharma Research B.V. 13/01/2017 VM Unknown AU Oral suspension QP52AG06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Oxyclozanide Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10521/019/001 VPA10521/019/001 Diurizone Injectable Vetoquinol S.A. 01/10/1989 VM Unknown AU Solution for injection QC03AX01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Hydrochlorothiazide Dexamethasone Prescription Only Medicine Cattle Horse (non-food producing) Cardiovascular VPA10846/020/001 VPA10846/020/001 DIVENCE TRI Laboratorios Hipra S.A. 24/01/2025 VM Unknown AU Lyophilisate and solvent for suspension for injection QI02AH Full application - known active substance (Article 8 of Regulation (EU) 2019/6) Intramuscular use Bovine respiratory syncytial virus, strain LYM-56, Live Infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, Live Bovine parainfluenza virus 3, strain SF-4 Reisinger, Inactivated Prescription Only Medicine Cattle Immunological - Mixed Vaccine (L & A) VPA10521/021/001 VPA10521/021/001 Dolethal 200 mg/ml Solution for Injection for dogs and cats Vetoquinol S.A. 01/10/1990 VM Unknown AU Solution for injection QN51AA01 Complete application (stand-alone) - Council Directive 81/851/EEC Intracardiac use Intravenous use Pentobarbital sodium Prescription Only Medicine Cats Dogs Neurological Preparations VPA10826/014/003 VPA10826/014/003 Dolocarp flavour, 100 mg, chewable tablet for dogs aniMedica GmbH 28/10/2011 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10826/014/001 VPA10826/014/001 Dolocarp flavour, 20 mg, chewable tablets for dogs aniMedica GmbH 28/10/2011 VM Marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10826/014/002 VPA10826/014/002 Dolocarp flavour, 50 mg, chewable tablet for dogs aniMedica GmbH 28/10/2011 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10989/053/001 VPA10989/053/001 Domidine 10 mg/ml solution for injection, for horses and cattle Eurovet Animal Health B.V. 27/09/2006 VM Unknown AU Solution for injection QN05CM90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Detomidine hydrochloride Prescription Only Medicine Cattle Horses Neurological Preparations VPA10664/005/001 VPA10664/005/001 Domitor 1 mg/ml solution for injection Orion Corporation 12/03/2010 VM Unknown AU Solution for injection QN05CM91 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Medetomidine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10664/004/001 VPA10664/004/001 Domosedan 10 mg/ml solution for injection for horses and cattle Orion Corporation 12/03/2010 VM Unknown AU Solution for injection QN05CM90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Detomidine hydrochloride Prescription Only Medicine Cattle Horses Neurological Preparations VPA10664/001/001 VPA10664/001/001 DOMOSEDAN GEL 7.6 mg/ml oromucosal gel Orion Corporation 27/02/2009 VM Unknown AU Oromucosal gel QN05CM90 Full application (Article 12(3) of Directive No 2001/82/EC) Sublingual use Detomidine hydrochloride Prescription Only Medicine Horses Neurological Preparations VPA10791/018/001 VPA10791/018/001 DOPHACYL 1000 mg/g powder for use in drinking water for turkeys Dopharma Research B.V. 24/06/2022 VM Unknown AU Powder for use in drinking water QN02BA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Sodium salicylate Prescription Only Medicine Turkeys N.S.A.I.D. VPA10791/019/001 VPA10791/019/001 Dophacyl 1000 mg/g, powder for use in drinking water/milk for cattle and pigs Dopharma Research B.V. 14/08/2023 VM Unknown AU Powder for use in drinking water/milk QN02BA04 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Sodium salicylate Prescription Only Medicine Cattle Pigs N.S.A.I.D. VPA10791/023/001 VPA10791/023/001 Dophacyl Avi, 1000 mg/g powder for use in drinking water for chickens Dopharma Research B.V. 11/10/2024 VM Unknown AU Powder for use in drinking water QN02BA04 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) In drinking water use Sodium salicylate Prescription Only Medicine Chickens N.S.A.I.D. VPA10791/022/001 VPA10791/022/001 Dophatyl-ject 200 000 IU/ml solution for injection for cattle, sheep, goats and pigs Dopharma Research B.V. 12/04/2024 VM Unknown AU Solution for injection QJ01FA90 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Tylosin Prescription Only Medicine Cattle Goats Pigs Sheep Antibacterial VPA10791/011/001 VPA10791/011/001 DOPHEXINE 20 mg/g powder for use in drinking water/milk Dopharma Research B.V. 02/10/2020 VM Unknown AU Powder for use in drinking water/milk QR05CB02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water/milk use Bromhexine Prescription Only Medicine Cattle Chickens Duck Pigs Turkeys Respiratory Tract preparations VPA10791/009/001 VPA10791/009/001 DORAFLOX 100 mg/ml solution for injection for cattle and pigs Dopharma Research B.V. 10/10/2014 VM Not marketed AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10987/170/001 VPA10987/170/001 Doramax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Chanelle Pharmaceuticals Manufacturing Limited 26/08/2022 VM Unknown AU Solution for injection QP54AA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Doramectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA10987/166/001 VPA10987/166/001 Doramax 5 mg/ml Pour-on Solution for Cattle Chanelle Pharmaceuticals Manufacturing Limited 09/04/2021 VM Unknown AU Pour-on solution QP54AA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Doramectin Prescription Only Medicine Cattle Endectoparasiticides VPA10791/015/001 VPA10791/015/001 DORAXX 25 mg/ml solution for injection for pigs Dopharma Research B.V. 07/01/2022 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Tulathromycin Prescription Only Medicine Pigs Antibacterial VPA10495/002/001 VPA10495/002/001 Dorbene vet 1 mg/ml solution for injection for dogs and cats Laboratorios Syva S.A. 02/03/2012 VM Unknown AU Solution for injection QN05CM91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Medetomidine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA22622/048/001 VPA22622/048/001 Dormazolam 5 mg/ml solution for injection for horses Dechra Regulatory B.V. 05/04/2024 VM Unknown AU Solution for injection QN05CD08 Full application - known active substance (Article 8 of Regulation (EU) 2019/6) Intravenous use Midazolam Prescription Only Medicine Horse (non-food producing) Neurological Preparations VPA10980/033/001 VPA10980/033/001 Dormostart 1 mg/ml solution for injection for dogs and cats Alfasan Nederland B.V. 13/10/2023 VM Unknown AU Solution for injection QN05CM91 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Medetomidine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10980/031/001 VPA10980/031/001 Dormostop 5 mg/ml solution for injection for dogs and cats Alfasan Nederland B.V. 18/08/2023 VM Unknown AU Solution for injection QV03AB90 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Atipamezole hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10774/046/001 VPA10774/046/001 Doxatib 500 mg/g powder for use in drinking water for pigs and chickens Krka, d.d., Novo mesto 09/09/2016 VM Not marketed AU Powder for use in drinking water QJ01AA02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Doxycycline hyclate Prescription Only Medicine Chickens Pigs Antibacterial VPA10790/008/001 VPA10790/008/001 Doxipulvis 500 mg/g powder for use in drinking water/milk SP Veterinaria, S.A. 30/09/2016 VM Unknown AU Oral powder QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycycline Prescription Only Medicine Cattle Chickens Pigs Turkeys Antibacterial VPA10400/002/001 VPA10400/002/001 Doxivex, 100 mg/ml concentrate for oral solution for chickens and pigs Duggan Veterinary Supplies Limited 03/08/2007 VM Marketed AU Oral solution QJ01AA02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Doxycycline hyclate Prescription Only Medicine Chickens Pigs Antibacterial VPA10782/017/001 VPA10782/017/001 Doxx-Sol 500 mg/g powder for use in drinking water/milk replacer for pre-ruminant calves, pigs and chickens Huvepharma NV 30/01/2015 VM Unknown AU Powder for oral solution QJ01AA02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Doxycycline hyclate Prescription Only Medicine Cattle Chickens Pigs Antibacterial VPA22622/044/002 VPA22622/044/002 Doxybactin 200 mg tablets for dogs Dechra Regulatory B.V. 08/09/2017 VM Unknown AU Tablet QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycyline Prescription Only Medicine Dogs Antibacterial VPA22622/044/003 VPA22622/044/003 Doxybactin 400 mg tablets for dogs Dechra Regulatory B.V. 08/09/2017 VM Unknown AU Tablet QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycyline Prescription Only Medicine Dogs Antibacterial VPA22622/044/001 VPA22622/044/001 Doxybactin 50 mg tablets for dogs and cats Dechra Regulatory B.V. 08/09/2017 VM Unknown AU Tablet QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycyline Prescription Only Medicine Cats Dogs Antibacterial VPA10491/013/002 VPA10491/013/002 Doxycare Flavour 200 mg Tablets for Cats and Dogs Ecuphar N.V. 25/10/2019 VM AU Tablet QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycycline hyclate Prescription Only Medicine Cats Dogs Antibacterial VPA10491/013/001 VPA10491/013/001 Doxycare Flavour 40 mg Tablets for Cats and Dogs Ecuphar N.V. 25/10/2019 VM AU Tablet QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycycline hyclate Prescription Only Medicine Cats Dogs Antibacterial VPA10791/021/001 VPA10791/021/001 Doxylin 500 mg/g, powder for use in drinking water/milk for pre-ruminant calves, pigs and chickens Dopharma Research B.V. 14/08/2023 VM Unknown AU Powder for use in drinking water/milk QJ01AA02 Full application - known active substance (Article 8 of Regulation (EU) 2019/6) Oral use Doxycycline hyclate Prescription Only Medicine Cattle Chickens Pigs Antibacterial VPA10791/007/001 VPA10791/007/001 Doxylin, 433 mg/g, powder for use in drinking water for chickens and turkeys Dopharma Research B.V. 29/05/2015 VM Marketed AU Powder for use in drinking water QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Doxycycline Prescription Only Medicine Chickens Turkeys Antibacterial VPA10810/020/001 VPA10810/020/001 Doxytab vet. 15 mg Tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 14/08/2020 VM Unknown AU Tablet QJ01AA02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Doxycycline Prescription Only Medicine Cats Dogs Antibacterial VPA10810/020/003 VPA10810/020/003 Doxytab vet. 200 mg Tablets for dogs CP-Pharma Handelsgesellschaft mbH 14/08/2020 VM Unknown AU Tablet QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycycline Prescription Only Medicine Dogs Antibacterial VPA10810/020/004 VPA10810/020/004 Doxytab vet. 400 mg Tablets for dogs CP-Pharma Handelsgesellschaft mbH 14/08/2020 VM Unknown AU Tablet QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycycline Prescription Only Medicine Dogs Antibacterial VPA10810/020/002 VPA10810/020/002 Doxytab vet. 50 mg Tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 14/08/2020 VM Unknown AU Tablet QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Doxycycline Prescription Only Medicine Cats Dogs Antibacterial VPA10791/002/001 VPA10791/002/001 Dozuril 25 mg/ml solution for use in drinking water for chickens Dopharma Research B.V. 25/05/2012 VM Marketed AU Solution for use in drinking water QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Chickens Coccidiostats VPA10791/016/001 VPA10791/016/001 Dozuril 50 mg/ml oral suspension for pigs Dopharma Research B.V. 27/05/2022 VM Unknown AU Oral suspension QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Pigs Coccidiostats VPA10387/099/001 VPA10387/099/001 Draxxin Plus 100 mg/ml + 120 mg/ml solution for injection for cattle Zoetis Belgium S.A. 25/08/2020 VM Unknown AU Solution for injection QJ01FA Fixed combination application (Article 13b of Directive No 2001/82/EC) Subcutaneous use Tulathromycin Ketoprofen Prescription Only Medicine Cattle Antibacterial VPA10521/005/001 VPA10521/005/001 Droncit Tablets 50 mg Vetoquinol S.A. 01/10/1989 VM Marketed AU Tablet QP52AA01 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Praziquantel Companion Animal Medicine Cats Dogs Endoparasiticide VPA10521/007/001 VPA10521/007/001 Drontal Cat Tablets Vetoquinol S.A. 22/09/1995 VM Marketed AU Tablet QP52AA51 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Praziquantel Pyrantel embonate Companion Animal Medicine Cats Endoparasiticide VPA10521/007/002 VPA10521/007/002 Drontal Cat XL film-coated tablets Vetoquinol S.A. 06/08/2004 VM Marketed AU Tablet QP52AA51 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Companion Animal Medicine Cats Endoparasiticide VPA10521/012/001 VPA10521/012/001 Drontal Dog Tasty Bone 150/144/50 mg tablets Vetoquinol SA 24/10/2014 VM Unknown AU Tablet QP52AC55 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA10521/012/002 VPA10521/012/002 Drontal Dog Tasty Bone XL 525/504/175 mg tablets Vetoquinol SA 27/10/2017 VM Unknown AU Tablet QP52AA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA10521/008/001 VPA10521/008/001 Drontal Oral Suspension for Puppies 15/5 mg/ml Vetoquinol S.A. 23/05/2008 VM Marketed AU Oral suspension QP52AF02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Companion Animal Medicine Dogs Endoparasiticide VPA10521/006/003 VPA10521/006/003 Drontal Plus Flavour Bone Shaped Tablets Vetoquinol S.A. 21/10/2005 VM Marketed AU Tablet QP52AC55 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Pyrantel embonate Praziquantel Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10521/011/001 VPA10521/011/001 Drontal Plus Flavour Tablets for Dogs Vetoquinol S.A. 25/01/2009 VM Marketed AU Tablet QP52AF30 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA10521/006/001 VPA10521/006/001 Drontal Plus Tablets Vetoquinol SA 12/10/1990 VM Marketed AU Tablet QP52AA51 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA10521/009/001 VPA10521/009/001 Drontal Plus XL Flavour Tablets for Dogs Vetoquinol S.A. 20/03/2009 VM Marketed AU Tablet QP52AF30 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10521/006/002 VPA10521/006/002 Drontal Plus XL Tablets Vetoquinol SA 17/10/2003 VM Marketed AU Tablet QP52AC55 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Pyrantel embonate Praziquantel Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10521/014/001 VPA10521/014/001 Drontal Tasty Bone Multi-worm 150/144/50 mg tablets Vetoquinol SA 24/10/2014 VM Unknown AU Tablet QP52AC55 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10521/014/002 VPA10521/014/002 Drontal Tasty Bone Multi-worm XL 525/504/175 mg tablets Vetoquinol SA 08/09/2017 VM Unknown AU Tablet QP52AA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10521/015/001 VPA10521/015/001 Drontal Tasty Bone Wormer 150/144/50 mg tablets Vetoquinol SA 24/10/2014 VM Unknown AU Tablet QP52AC55 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10521/015/002 VPA10521/015/002 Drontal Tasty Bone Wormer XL 525/504/175 mg tablets Vetoquinol SA 08/09/2017 VM Unknown AU Tablet QP52AA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA22020/069/001 VPA22020/069/001 DrySeal intramammary suspension Elanco GmbH 27/09/2024 VM Unknown AU Intramammary suspension QG52X Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Intramammary use Bismuth subnitrate Licensed Retailer Cattle Teat Dip/Seal VPA25460/003/001 VPA25460/003/001 Dugmectin 18.7 mg/g Oral Paste for Horses Acme Drugs S.r.l. 05/01/2007 VM Marketed AU Oral paste QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Horses Endectoparasiticides VPA10477/004/001 VPA10477/004/001 Dugnixon 50 mg/ml solution for injection for cattle, pigs and horses Global Vet Health S.L. 15/12/2017 VM Unknown AU Solution for injection QM01AG90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Flunixin meglumine Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10990/009/001 VPA10990/009/001 Duocycline 10% Solution for Injection Univet Limited 01/10/1988 VM Not marketed AU Solution for injection QJ01AA06 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Oxytetracycline hydrochloride Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10990/016/001 VPA10990/016/001 Duocycline LA 200 mg/ml Solution for Injection Univet Limited 01/10/1988 VM Unknown AU Solution for injection QJ01AA06 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Oxytetracycline dihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22664/003/001 VPA22664/003/001 Duofast Intramammary Suspension Norbrook Laboratories (Ireland) Limited 05/02/1999 VM Unknown AU Intramammary suspension QJ51 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramammary use Sulphadiazine Trimethoprim Prescription Only Medicine Cattle Antibacterial VPA23340/007/001 VPA23340/007/001 DUOMYXIN, 3 400 IU/ml/10 000 IU/ml, Eye drops, powder and solvent for solution for dogs and cats Domes Pharma 09/12/2022 VM Unknown AU Eye drops, powder and solvent for solution QS01AA30 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Ocular use Neomycin sulfate Polymyxin b sulfate Prescription Only Medicine Cats Dogs Antibacterial VPA22664/057/001 VPA22664/057/001 Duotech Oral Suspension for Sheep Norbrook Laboratories (Ireland) Limited 04/05/2001 VM Unknown AU Oral suspension QP52AC30 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Oxfendazole Closantel sodium dihydrate Prescription Only Medicine Sheep Endoparasiticide VPA10400/004/001 VPA10400/004/001 DV8FLEA COMBO 50 mg/60 mg spot-on solution for cats and ferrets Duggan Veterinary Supplies Limited 12/04/2024 VM Unknown AU Spot-on solution QP53AX65 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Spot-on use Fipronil (S)-Methoprene Companion Animal Medicine Cats Ferrets Ectoparasiticide VPA10400/005/003 VPA10400/005/003 DV8FLEA COMBO L 268 mg/241.2 mg spot-on solution for dogs Duggan Veterinary Supplies Limited 12/04/2024 VM Unknown AU Spot-on solution QP53AX65 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Spot-on use Fipronil (S)-Methoprene Companion Animal Medicine Dogs Ectoparasiticide VPA10400/005/002 VPA10400/005/002 DV8FLEA COMBO M 134 mg/120.6 mg spot-on solution for dogs Duggan Veterinary Supplies Limited 12/04/2024 VM Unknown AU Spot-on solution QP53AX65 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Spot-on use Fipronil (S)-Methoprene Companion Animal Medicine Dogs Ectoparasiticide VPA10400/005/001 VPA10400/005/001 DV8FLEA COMBO S 67 mg/60.3 mg spot-on solution for dogs Duggan Veterinary Supplies Limited 12/04/2024 VM Unknown AU Spot-on solution QP53AX65 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Spot-on use Fipronil (S)-Methoprene Companion Animal Medicine Dogs Ectoparasiticide VPA10400/005/004 VPA10400/005/004 DV8FLEA COMBO XL 402 mg/361.8 mg spot-on solution for dogs Duggan Veterinary Supplies Limited 12/04/2024 VM Unknown AU Spot-on solution QP53AX65 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Spot-on use Fipronil (S)-Methoprene Companion Animal Medicine Dogs Ectoparasiticide VPA10400/001/001 VPA10400/001/001 DV8WORM 50 mg/144 mg/200 mg Tablets for dogs Duggan Veterinary Supplies Limited 27/05/2022 VM Unknown AU Tablet QP52AA51 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Fenbendazole Companion Animal Medicine Dogs Endoparasiticide VPA10987/122/001 VPA10987/122/001 Dycoxan 2.5 mg/ml Oral Suspension for sheep and cattle Chanelle Pharmaceuticals Manufacturing Limited 04/05/2018 VM Unknown AU Oral suspension QP51AJ03 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Diclazuril Prescription Only Medicine Cattle Sheep Coccidiostats VPA22033/012/001 VPA22033/012/001 Ecofleece 100 mg/g Concentrate for dip emulsion for sheep Bimeda Animal Health Limited 11/09/1996 VM Unknown AU Concentrate for dip emulsion QP53AC Informed consent application (Article 13c of Directive No 2001/82/EC) Cutaneous use Cypermethrin (Cis:Trans 80:20) Prescription Only Medicine Sheep Ectoparasiticide VPA22693/001/001 VPA22693/001/001 Ecomectin 10 mg/ml Solution for Injection ECO Animal Health Europe Limited 01/01/1900 VM Unknown AU Solution for injection QP54AA01 Well-established use application (Article 13a of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA25460/002/001 VPA25460/002/001 Ecomectin 18.7 mg/g Oral Paste for Horses Acme Drugs S.r.l. 05/01/2007 VM Unknown AU Oral paste QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Horses Endectoparasiticides VPA22693/013/001 VPA22693/013/001 Ecomectin 6 mg/g Oral Powder for pigs ECO Animal Health Europe Limited 22/10/2010 VM Not marketed AU Oral powder QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Pigs Endectoparasiticides VPA22693/011/001 VPA22693/011/001 Ecomectin 6 mg/g Premix for medicated feeding stuff for pigs ECO Animal Health Europe Limited 02/05/2008 VM Unknown AU Premix for medicated feeding stuff QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) In-feed use Ivermectin Prescription Only Medicine Pigs Endectoparasiticides VPA22033/013/001 VPA22033/013/001 Ectoflits Summer and Winter Sheep Dip 600 mg/g Concentrate for Dip Solution Bimeda Animal Health Limited 03/11/2006 VM Unknown AU Concentrate for dip solution QP53AF Informed consent application (Article 13c of Directive No 2001/82/EC) Cutaneous use Dimpylate Prescription Only Medicine Sheep Ectoparasiticide VPA22033/059/001 VPA22033/059/001 Ectofly 12.5 mg/ml Pour-On Solution for Sheep Bimeda Animal Health Limited 20/04/2012 VM Unknown AU Pour-on solution QP53AC08 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Cypermethrin high:cis (80:20) Prescription Only Medicine Sheep Ectoparasiticide VPA22033/014/001 VPA22033/014/001 Ectospec 2.5% w/v Pour-On Solution Bimeda Animal Health Limited 09/12/2013 VM Unknown AU Pour-on solution QP53AC08 Informed consent application (Article 13c of Directive No 2001/82/EC) Pour-on use Cypermethrin technical (93%) (cis: trans 50:50) Prescription Only Medicine Cattle Ectoparasiticide VPA10815/036/001 VPA10815/036/001 Efex 10 mg chewable tablets for cats and dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01MA93 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Cats Dogs Antibacterial VPA10815/036/003 VPA10815/036/003 Efex 100 mg chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01MA93 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Dogs Antibacterial VPA10815/036/002 VPA10815/036/002 Efex 40 mg chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01MA93 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Dogs Antibacterial VPA10988/076/002 VPA10988/076/002 EFFIPRO 134 mg spot-on solution for medium dogs Virbac 15/05/2009 VM Marketed AU Cutaneous solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10988/072/001 VPA10988/072/001 EFFIPRO 2.5 mg/ml cutaneous spray, solution for cats and dogs Virbac 15/05/2009 VM Marketed AU Cutaneous spray, solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Cutaneous use Fipronil Prescription Only Medicine Cats Dogs Ectoparasiticide VPA10988/076/003 VPA10988/076/003 EFFIPRO 268 mg spot-on solution for large dogs Virbac 15/05/2009 VM Marketed AU Cutaneous solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10988/076/004 VPA10988/076/004 EFFIPRO 402 mg spot-on solution for very large dogs Virbac 15/05/2009 VM Marketed AU Cutaneous solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10988/075/001 VPA10988/075/001 EFFIPRO 50 mg spot-on solution for cats Virbac 15/05/2009 VM Marketed AU Cutaneous solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Cutaneous use Fipronil Prescription Only Medicine Cats Ectoparasiticide VPA10988/076/001 VPA10988/076/001 EFFIPRO 67 mg spot-on solution for small dogs Virbac 15/05/2009 VM Marketed AU Cutaneous solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10988/100/006 VPA10988/100/006 Effipro duo 100 mg/120 mg spot-on solution for very large cats Virbac 19/11/2015 VM Unknown AU Spot-on solution QP53AX65 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Pyriproxyfen Prescription Only Medicine Cats Ectoparasiticide VPA10988/100/002 VPA10988/100/002 Effipro duo 134 mg/40 mg spot-on solution for medium dogs Virbac 19/11/2015 VM Unknown AU Spot-on solution QP53AX65 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Pyriproxyfen Prescription Only Medicine Dogs Ectoparasiticide VPA10988/100/003 VPA10988/100/003 Effipro duo 268 mg/80 mg spot-on solution for large dogs Virbac 19/11/2015 VM Unknown AU Spot-on solution QP53AX65 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Pyriproxyfen Prescription Only Medicine Dogs Ectoparasiticide VPA10988/100/004 VPA10988/100/004 Effipro duo 402 mg/120 mg spot-on solution for very large dogs Virbac 19/11/2015 VM Unknown AU Spot-on solution QP53AX65 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Pyriproxyfen Prescription Only Medicine Dogs Ectoparasiticide VPA10988/100/005 VPA10988/100/005 Effipro duo 50 mg/60 mg spot-on solution for cats Virbac 19/11/2015 VM Unknown AU Spot-on solution QP53AX65 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Pyriproxyfen Prescription Only Medicine Cats Ectoparasiticide VPA10988/100/001 VPA10988/100/001 Effipro duo 67 mg/20 mg spot-on solution for small dogs Virbac 19/11/2015 VM Unknown AU Spot-on solution QP53AX65 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Pyriproxyfen Prescription Only Medicine Dogs Ectoparasiticide VPA10988/097/003 VPA10988/097/003 Effitix 134 mg/1200 mg spot-on solution for medium dogs Virbac 19/09/2014 VM Marketed AU Spot-on solution QP53AC54 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Permethrin Prescription Only Medicine Dogs Ectoparasiticide VPA10988/097/001 VPA10988/097/001 Effitix 26.8 mg/240 mg spot-on solution for very small dogs Virbac 19/09/2014 VM Marketed AU Spot-on solution QP53AC54 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Permethrin Prescription Only Medicine Dogs Ectoparasiticide VPA10988/097/004 VPA10988/097/004 Effitix 268 mg/2400 mg spot-on solution for large dogs Virbac 19/09/2014 VM Marketed AU Spot-on solution QP53AC54 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Permethrin Prescription Only Medicine Dogs Ectoparasiticide VPA10988/097/005 VPA10988/097/005 Effitix 402 mg/3600 mg spot-on solution for very large dogs Virbac 19/09/2014 VM Marketed AU Spot-on solution QP53AC54 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Permethrin Prescription Only Medicine Dogs Ectoparasiticide VPA10988/097/002 VPA10988/097/002 Effitix 67 mg/600 mg spot-on solution for small dogs Virbac 19/09/2014 VM Marketed AU Spot-on solution QP53AC54 Fixed combination application (Article 13b of Directive No 2001/82/EC) Spot-on use Fipronil Permethrin Prescription Only Medicine Dogs Ectoparasiticide VPA10846/006/001 VPA10846/006/001 EFICUR 50 mg/ml suspension for injection for pigs and cattle Laboratorios Hipra S.A. 28/05/2007 VM Marketed AU Suspension for injection QJ01DD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Ceftiofur hydrochloride Prescription Only Medicine Cattle Pigs Antibacterial VPA10481/002/001 VPA10481/002/001 EKYFLOGYL 1.8mg/ml + 8.7mg/ml GEL FOR HORSES Audevard 11/10/2019 VM Unknown AU Gel QM02AX Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Prednisolone Lidocaine Prescription Only Medicine Horses Corticosteroid VPA10509/014/001 VPA10509/014/001 Elivec 5 mg/ml pour-on solution for cattle, sheep and goats. Industrial Veterinaria S.A. 25/05/2018 VM Marketed AU Pour-on solution QP54AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Goats Sheep Endectoparasiticides VPA22033/015/001 VPA22033/015/001 Embotape 400 mg/g Oral Paste for Horses and Ponies Bimeda Animal Health Limited 09/01/1998 VM Unknown AU Oral paste QP52AF02 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Pyrantel embonate Prescription Only Medicine Horses Endoparasiticide VPA10534/008/001 VPA10534/008/001 Emdofluxin 50 mg/ml solution for injection for cattle, pigs and horses Emdoka 07/08/2020 VM Unknown AU Solution for injection QM01AG90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Flunixin meglumine Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA23340/008/001 VPA23340/008/001 Emedog 1 mg/ml solution for injection for dogs Domes Pharma 21/07/2023 VM Unknown AU Solution for injection QN04BC07 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Subcutaneous use Apomorphine hydrochloride hemihydrate Prescription Only Medicine Dogs Neurological Preparations VPA10815/017/001 VPA10815/017/001 Emeprid 1 mg/ml oral solution for dogs and cats Ceva Santé Animale 10/12/2010 VM Unknown AU Oral solution QA03FA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Metoclopramide hydrochloride Prescription Only Medicine Cats Dogs Alimentary Tract Preparation VPA10815/018/001 VPA10815/018/001 Emeprid 5 mg/ml solution for injection for dogs and cats Ceva Santé Animale 10/12/2010 VM Unknown AU Solution for injection QA03FA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Metoclopramide hydrochloride Prescription Only Medicine Cats Dogs Alimentary Tract Preparation VPA22033/060/001 VPA22033/060/001 Endofluke 100 mg/ml Oral Suspension Bimeda Animal Health Limited 01/08/2002 VM Unknown AU Oral suspension QP52AC01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Triclabendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10774/004/001 VPA10774/004/001 Endogard Plus Flavour Tablets for dogs Krka, d.d., Novo mesto 03/06/2011 VM Unknown AU Tablet QP52AC55 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA10774/004/002 VPA10774/004/002 Endogard Plus XL Tablets for dogs Krka, d.d., Novo mesto 03/06/2011 VM Unknown AU Tablet QP52AC55 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA22033/016/001 VPA22033/016/001 Endospec 100 mg/ml SC Oral Suspension for Cattle and Sheep Bimeda Animal Health Limited 23/09/1996 VM Marketed AU Oral suspension QP52AC11 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Albendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA22033/017/001 VPA22033/017/001 Endospec 25 mg/ml SC Oral Suspension for Cattle and Sheep Bimeda Animal Health Limited 23/09/1996 VM Marketed AU Oral suspension QP52AC11 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Albendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10996/071/001 VPA10996/071/001 Engemycin DD 100 mg/ml Solution for injection Intervet Ireland Limited 01/10/1988 VM Unknown AU Solution for injection QJ01AA06 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Oxytetracycline hydrochloride Prescription Only Medicine Cats Cattle Dogs Horses Pigs Sheep Antibacterial VPA10996/212/001 VPA10996/212/001 Engemycin Spray, 25 mg/mL, cutaneous spray, suspension for cattle, sheep and pigs Intervet Ireland Limited 02/10/2009 VM Marketed AU Cutaneous spray, suspension QD06AA03 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Cutaneous use Oxytetracycline hydrochloride Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22664/055/001 VPA22664/055/001 Enovex 10 mg/ml Solution for Injection for cattle, sheep and pigs Norbrook Laboratories (Ireland) Limited 29/10/1999 VM Unknown AU Solution for injection QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA22664/056/001 VPA22664/056/001 Enovex 5 mg/ml Pour-On Solution for Cattle Norbrook Laboratories (Ireland) Limited 29/10/1999 VM Unknown AU Pour-on solution QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10786/001/001 VPA10786/001/001 ENRO-K 100 mg/ml Solution for use in drinking water for chickens and turkeys. Laboratorios Karizoo S.A. 28/08/2009 VM Not marketed AU Oral solution QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Chickens Turkeys Antibacterial VPA10475/020/001 VPA10475/020/001 Enrobactin 25 mg/ml concentrate for oral solution for pet rabbits, rodents, ornamental birds and reptiles Le Vet Beheer B.V. 15/01/2016 VM Unknown AU Oral solution QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Chinchilla Gerbil Guinea pig Hamster Mouse Ornamental birds Rat Reptiles Rabbit (non-food-producing) Antibacterial VPA10534/007/003 VPA10534/007/003 Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs Emdoka 27/09/2013 VM Unknown AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10491/007/004 VPA10491/007/004 Enrocare 25 mg/ml Oral Solution for Pet Rabbits, Rodents, Ornamental Birds and Reptiles Ecuphar N.V. 26/05/2017 VM Unknown AU Oral solution QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Chinchilla Gerbil Guinea pig Hamster Mouse Ornamental birds Rat Reptiles Rabbit (non-food-producing) Antibacterial VPA10534/007/001 VPA10534/007/001 Enrocare 25 mg/ml Solution for Injection for Dogs, Cats, Rabbits, Rodents, Reptiles and Ornamental birds Emdoka 27/09/2013 VM Unknown AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Enrofloxacin Prescription Only Medicine Cats Chinchilla Dogs Gerbil Guinea pig Hamster Mouse Ornamental birds Rabbits Rat Reptiles Antibacterial VPA10534/007/002 VPA10534/007/002 Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats Emdoka 27/09/2013 VM Unknown AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cats Cattle Dogs Pigs Antibacterial VPA10509/019/001 VPA10509/019/001 Enrocat flavour 25 mg/ml oral suspension for cats Industrial Veterinaria S.A. 08/05/2020 VM AU Oral suspension QJ01MA90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Cats Antibacterial VPA10509/004/001 VPA10509/004/001 ENRODEXIL 100 mg/ml solution for injection for cattle and pigs Industrial Veterinaria S.A. 28/06/2012 VM Not marketed AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10826/026/003 VPA10826/026/003 Enrotron 100 mg/ml Solution for injection for cattle, sheep, goats and pigs aniMedica GmbH 20/04/2012 VM Marketed AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Goats Pigs Sheep Antibacterial VPA10826/018/001 VPA10826/018/001 Enrotron 100 mg/ml solution for use in drinking water for chicken, turkeys and rabbits aniMedica GmbH 21/06/2013 VM Marketed AU Oral solution QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Chickens Rabbits Turkeys Antibacterial VPA10826/026/001 VPA10826/026/001 Enrotron 25 mg/ml Solution for injection for dogs, cats, rodents, reptiles and ornamental birds aniMedica GmbH 20/04/2012 VM Marketed AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Enrofloxacin Prescription Only Medicine Cats Chinchilla Dogs Gerbil Guinea pig Hamster Mouse Ornamental birds Rat Reptiles Antibacterial VPA10826/016/001 VPA10826/016/001 Enrotron 5 mg/ml oral solution for pigs aniMedica GmbH 21/06/2013 VM Marketed AU Oral solution QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Pigs Antibacterial VPA10826/026/002 VPA10826/026/002 Enrotron 50 mg/ml Solution for injection for cattle, sheep, goats, pigs, dogs and cats aniMedica GmbH 20/04/2012 VM Marketed AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cats Cattle Dogs Goats Pigs Sheep Antibacterial VPA10826/011/002 VPA10826/011/002 Enrotron Flavour 150 mg Tablets for dogs aniMedica GmbH 26/11/2010 VM Marketed AU Tablet QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Dogs Antibacterial VPA10826/011/001 VPA10826/011/001 Enrotron Flavour 50 mg Tablets for dogs aniMedica GmbH 26/11/2010 VM Marketed AU Tablet QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Dogs Antibacterial VPA10774/001/001 VPA10774/001/001 Enrox Flavour 15 mg Tablets for dogs and cats Krka, d.d., Novo mesto 12/06/2009 VM Marketed AU Tablet QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Cats Dogs Antibacterial VPA10774/001/003 VPA10774/001/003 Enrox Flavour 150 mg Tablets for dogs Krka, d.d., Novo mesto 12/06/2009 VM Marketed AU Tablet QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Dogs Antibacterial VPA10774/001/002 VPA10774/001/002 Enrox Flavour 50 mg Tablets for dogs Krka, d.d., Novo mesto 12/06/2009 VM Marketed AU Tablet QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Dogs Antibacterial VPA10774/002/003 VPA10774/002/003 Enroxil 100 mg/ml solution for injection for cattle and pigs Krka, d.d., Novo mesto 10/07/2009 VM Unknown AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10774/002/002 VPA10774/002/002 ENROXIL 50 mg/ml solution for injection for calves, pigs and dogs Krka, d.d., Novo mesto 10/07/2009 VM Unknown AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Dogs Pigs Antibacterial VPA10774/002/001 VPA10774/002/001 Enroxil Max 100 mg/ml solution for injection for cattle Krka, d.d., Novo mesto 19/09/2008 VM Unknown AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Antibacterial VPA10784/003/001 VPA10784/003/001 Entericolix, emulsion for injection for pig CZ Vaccines S.A.U. 16/03/2016 VM Unknown AU Emulsion for injection QI09AB08 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use E.coli strain p4 (f6 adhesins), inactivated E.coli strain p5 (f18 adhesins), inactivated E. coli strain p6 (f4ac adhesins), inactivated E. coli strain P9 (F18ac adhesins), inactivated E.coli strain p10 (f5 + f41 adhesins), inactivated ß toxoid of C. perfringens type C Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA10454/005/001 VPA10454/005/001 Enterisol Ileitis lyophilisate and solvent for oral suspension for pigs Boehringer Ingelheim Vetmedica GmbH 07/07/2005 VM Unknown AU Lyophilisate and solvent for oral suspension QI09AE04 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Attenuated live bacteria lawsonia intracellularis (ms b3903) Prescription Only Medicine Pigs Immunological - Live Vaccine VPA10815/002/001 VPA10815/002/001 Enzaprost 5 mg/ml Solution for injection for cattle and pig Ceva Santé Animale 30/07/2004 VM Unknown AU Solution for injection QG02AD01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Dinoprost trometamol Prescription Only Medicine Cattle Pigs Hormone VPA10996/079/001 VPA10996/079/001 Enzovax lyophilisate and solvent for suspension for injection for sheep Intervet Ireland Limited 15/11/2002 VM Marketed AU Lyophilisate and solvent for suspension for injection QI04AE01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Chlamydophila abortus live attenuated strain ts 1b Prescription Only Medicine Sheep Immunological - Live Vaccine VPA10987/100/001 VPA10987/100/001 Epityl 60mg Flavoured Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 13/09/2013 VM Unknown AU Chewable tablet QN03AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10815/024/001 VPA10815/024/001 Eprecis 20 mg/ml solution for injection for cattle, sheep and goats Ceva Santé Animale 11/09/2015 VM Unknown AU Solution for injection QP54AA04 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Subcutaneous use Eprinomectin Prescription Only Medicine Cattle Goats Sheep Endectoparasiticides VPA10815/025/001 VPA10815/025/001 Eprecis 5 mg/ml pour-on solution for cattle, sheep and goats Ceva Santé Animale 21/08/2015 VM Unknown AU Pour-on solution QP54AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Goats Sheep Endectoparasiticides VPA10454/033/001 VPA10454/033/001 Eprinex 5 mg/ml Pour-on Solution for Beef and Dairy Cattle Boehringer Ingelheim Vetmedica GmbH 14/08/1998 VM Not marketed AU Pour-on solution QP54AA04 Full application (Article 12(3) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Endectoparasiticides VPA10454/034/001 VPA10454/034/001 Eprinex Multi 5 mg/ml pour-on solution for cattle, sheep and goats Boehringer Ingelheim Vetmedica GmbH 09/12/2016 VM Unknown AU Pour-on solution QP54AA04 Well-established use application (Article 13a of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Goats Sheep Endectoparasiticides VPA10454/035/001 VPA10454/035/001 Eprivalan 5 mg/ml pour-on solution for cattle Boehringer Ingelheim Vetmedica GmbH 30/09/2016 VM Not marketed AU Pour-on solution QP54AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Endectoparasiticides VPA22664/103/001 VPA22664/103/001 Eprizero 5 mg/ml Pour-On Solution for Beef and Dairy Cattle Norbrook Laboratories (Ireland) Limited 01/03/2013 VM Unknown AU Pour-on solution QP54AA04 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/107/001 VPA10987/107/001 Epromec 5 mg/ml Pour-on Solution for beef and dairy cattle Chanelle Pharmaceuticals Manufacturing Limited 22/05/2015 VM Unknown AU Pour-on solution QP54AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Endectoparasiticides VPA10387/025/001 VPA10387/025/001 EQUEST ORAL GEL, 18.92 mg/g, oral gel for horses and ponies Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Oral gel QP54AB02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Moxidectin Prescription Only Medicine Horses Endectoparasiticides VPA10387/026/001 VPA10387/026/001 Equest Pramox 19.5 mg/g + 121.7 mg/g oral gel Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Oral gel QP54AB52 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Moxidectin Praziquantel Prescription Only Medicine Horses Endectoparasiticides VPA10475/037/001 VPA10475/037/001 Equibactin 250 mg/g + 50 mg/g oral powder for horses Le Vet Beheer B.V. 05/07/2019 VM Unknown AU Oral powder QJ01EW10 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Sulfadiazine Trimethoprim Prescription Only Medicine Horses Antibacterial VPA10816/004/001 VPA10816/004/001 Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for horses Le Vet BV 21/07/2008 VM Unknown AU Oral paste QJ01EW10 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Trimethoprim Sulfadiazine Prescription Only Medicine Horses Antibacterial VPA10400/007/001 VPA10400/007/001 EquiDaz Forte 100 mg/ml oral suspension for horses Duggan Veterinary Supplies Limited 04/07/2025 VM Unknown AU Oral suspension QP52AC13 Informed Consent application (Article 21 of Regulation (EU) 2019/6) Oral use Fenbendazole Prescription Only Medicine Horses Endoparasiticide VPA10988/091/001 VPA10988/091/001 Equimax oral gel for horses Virbac 18/01/2013 VM Unknown AU Oral gel QP54AA51 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Ivermectin Praziquantel Prescription Only Medicine Horses Endectoparasiticides VPA22664/114/001 VPA22664/114/001 Equinor 370 mg/g Oral Paste for Horses Norbrook Laboratories (Ireland) Limited 26/07/2013 VM Unknown AU Oral paste QA02BC01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Omeprazole Prescription Only Medicine Horses Alimentary Tract Preparation VPA10387/027/001 VPA10387/027/001 Equip Artervac emulsion for injection for horses and ponies Zoetis Belgium S.A. 21/06/2013 VM Marketed AU Emulsion for injection QI05AA07 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Equine arteritis virus inactivated, strain bucyrus Prescription Only Medicine Horses Immunological - Inactivated Vaccine VPA10387/028/001 VPA10387/028/001 Equip EHV 1,4 Suspension for injection Zoetis Belgium S.A. 26/09/2014 VM Unknown AU Suspension for injection QI05AA05 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Equine herpes virus 4, strain 405/76 inactivated Equine herpes virus 1, strain 438/77 inactivated Prescription Only Medicine Horses Immunological - Inactivated Vaccine VPA10387/029/001 VPA10387/029/001 Equip F solution for injection Zoetis Belgium S.A. 30/05/2014 VM Unknown AU Solution for injection QI05AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated equine influenza a newmarket 77 (H7 N7) Inactivated equine influenza a borlonge 91 (H3 N8) Inactivated equine influenza a Kentucky 98 (H3 N8) Prescription Only Medicine Horses Immunological - Inactivated Vaccine VPA10387/030/001 VPA10387/030/001 Equip FT Zoetis Belgium S.A. 04/07/2014 VM Marketed AU Suspension for injection QI05AL01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated equine influenza a newmarket 77 (H7 N7) Inactivated equine influenza a borlonge 91 (H3 N8) Inactivated equine influenza a Kentucky 98 (H3 N8) Tetanus toxoid Prescription Only Medicine Horses Immunological - Inactivated Vaccine VPA10387/031/001 VPA10387/031/001 Equip Rotavirus emulsion for injection for horses Zoetis Belgium S.A. 21/06/2013 VM Unknown AU Emulsion for injection QI05AA09 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Equine rotavirus H2 strain Prescription Only Medicine Horses Immunological - Inactivated Vaccine VPA10387/032/001 VPA10387/032/001 Equip T Zoetis Belgium S.A. 04/07/2014 VM Marketed AU Suspension for injection QI05AB03 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Tetanus toxoid Prescription Only Medicine Horses Immunological - Inactivated Vaccine VPA22622/007/001 VPA22622/007/001 Equipalazone 1 g Oral Paste Dechra Regulatory B.V. 01/10/2005 VM Unknown AU Oral paste QM01AA01 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Phenylbutazone Prescription Only Medicine Cattle Sheep Horse (non-food producing) N.S.A.I.D. VPA22622/006/001 VPA22622/006/001 Equipalazone 1 g Oral Powder Dechra Regulatory B.V. 01/10/2001 VM Unknown AU Oral powder QM01AA01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Phenylbutazone Prescription Only Medicine Horse (non-food producing) N.S.A.I.D. VPA10826/006/001 VPA10826/006/001 Equiparin 5,000 IU/100 g gel for horses aniMedica GmbH 24/01/2010 VM Not marketed AU Gel QM02AC99 Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Heparin sodium Hydroxyethyl Salicylate Levomenthol Prescription Only Medicine Horses Miscellaneous VPA10826/006/002 VPA10826/006/002 Equiparin 50,000 IU/100 g gel for horses aniMedica GmbH 24/01/2010 VM Not marketed AU Gel QM02AC99 Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Heparin sodium Hydroxyethyl Salicylate Levomenthol Prescription Only Medicine Horses Miscellaneous VPA10810/017/001 VPA10810/017/001 Equipred 50 mg tablets for horses CP-Pharma Handelsgesellschaft mbH 15/11/2019 VM Unknown AU Tablet QH02AB06 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Prednisolone Prescription Only Medicine Horses Corticosteroid VPA10810/014/001 VPA10810/014/001 Equizol 400 mg gastro-resistant granules for horses CP-Pharma Handelsgesellschaft mbH 20/07/2018 VM Unknown AU Gastro-resistant granules QA02BC01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Omeprazole Prescription Only Medicine Horses Alimentary Tract Preparation VPA10454/036/001 VPA10454/036/001 EQVALAN DUO, oral paste Boehringer Ingelheim Vetmedica GmbH 27/05/2005 VM Unknown AU Oral paste QP54AA51 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Ivermectin Praziquantel Prescription Only Medicine Horses Endectoparasiticides VPA10454/037/001 VPA10454/037/001 EQVALAN Oral Paste for Horses 18.7 mg/g Boehringer Ingelheim Vetmedica GmbH 01/10/2000 VM Unknown AU Oral paste QP54AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Horses Endectoparasiticides VPA10988/109/001 VPA10988/109/001 ERADIA 125 mg/ml oral suspension for dogs Virbac 13/04/2018 VM Unknown AU Oral suspension QJ01XD01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Dogs Antibacterial VPA10988/104/001 VPA10988/104/001 ERAQUELL 18.7 mg/g Oral Paste Virbac 15/04/2016 VM Unknown AU Oral paste QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Horses Endectoparasiticides VPA10509/005/001 VPA10509/005/001 Espacox 50 mg/ml oral suspension for pigs Industrial Veterinaria S.A. 04/07/2014 VM Marketed AU Oral suspension QP51BC01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Pigs Coccidiostats VPA10996/227/001 VPA10996/227/001 Estrumate 250 micrograms/ml Solution for injection Intervet Ireland Limited 14/10/2011 VM Unknown AU Solution for injection QG02AD90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Cloprostenol Prescription Only Medicine Cattle Donkey Goats Horses Pigs Hormone VPA10454/038/001 VPA10454/038/001 Eurican DAP lyophilisate and solvent for suspension for injection Boehringer Ingelheim Vetmedica GmbH 15/07/2016 VM Not marketed AU Lyophilisate and solvent for suspension for injection QI07AD02 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Attenuated canine distemper virus, strain ba5 Attenuated canine adenovirus type 2, strain dk13 Attenuated canine parvovirus, strain cgf Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10454/039/001 VPA10454/039/001 Eurican DAPPi lyophilisate and solvent for suspension for injection Boehringer Ingelheim Vetmedica GmbH 22/07/2016 VM Not marketed AU Lyophilisate and solvent for suspension for injection QI07AD04 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Attenuated canine distemper virus, strain ba5 Attenuated canine adenovirus type 2, strain dk13 Attenuated canine parvovirus, strain cag2 Attenuated canine parainfluenza virus type 2, strain cgf 2004/75 Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10454/040/001 VPA10454/040/001 Eurican DHPPi lyophilisate for suspension for injection Boehringer Ingelheim Vetmedica GmbH 28/10/2005 VM Unknown AU Lyophilisate for suspension for injection QI07AD04 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Attenuated canine distemper virus, strain ba5 Attenuated canine adenovirus type 2, strain dk13 Attenuated canine parvovirus, strain cag2 Attenuated canine parainfluenza virus type 2, strain cgf 2004/75 Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10987/117/003 VPA10987/117/003 Eurofen 100 mg Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 28/08/2015 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/117/001 VPA10987/117/001 Eurofen 20 mg Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 28/08/2015 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/117/002 VPA10987/117/002 Eurofen 50 mg Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 28/08/2015 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10980/014/001 VPA10980/014/001 Euthanimal 200 mg/ml, solution for injection Alfasan Nederland B.V. 29/08/2013 VM Marketed AU Solution for injection QN51AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intravenous use Intracardiac use Intraperitoneal use Sodium pentobarbital Prescription Only Medicine Cats Cattle Dogs Pigs Sheep Horse (non-food producing) Chickens Duck Frog Goats Guinea pig Hamster Mouse Ornamental birds Pigeons Rabbit (non-food-producing) Rat Reptiles Snake Turtle Neurological Preparations VPA10980/014/002 VPA10980/014/002 Euthanimal 400 mg/ml, solution for injection Alfasan Nederland B.V. 29/08/2013 VM Marketed AU Solution for injection QN51AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intravenous use Intracardiac use Intraperitoneal use Sodium pentobarbital Prescription Only Medicine Cats Cattle Dogs Pigs Sheep Horse (non-food producing) Chickens Duck Frog Goats Guinea pig Hamster Mouse Ornamental birds Pigeons Rabbit (non-food-producing) Rat Reptiles Snake Turtle Neurological Preparations VPA10816/011/001 VPA10816/011/001 Euthasol vet. 400 mg/ml, solution for injection Le Vet BV 16/12/2011 VM Unknown AU Solution for injection QN51AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intracardiac use Intraperitoneal use Intravenous use Pentobarbital sodium Prescription Only Medicine Cats Cattle Chinchilla Dogs Gerbil Goats Guinea pig Hamster Mink Mouse Rat Sheep Horse (non-food producing) Rabbit (non-food-producing) Neurological Preparations VPA10400/008/001 VPA10400/008/001 EUTHATAL solution for injection 200 mg in 1 ml Duggan Veterinary Supplies Limited 01/10/1995 VM Unknown AU Solution for injection QN51AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intravenous use Pentobarbital sodium Prescription Only Medicine Cats Dogs Neurological Preparations VPA10987/115/001 VPA10987/115/001 Euthoxin 500 mg/ml solution for injection. Chanelle Pharmaceuticals Manufacturing Limited 15/04/2016 VM Unknown AU Solution for injection QN51AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intracardiac use Intraperitoneal use Intrapulmonary use Intravenous use Pentobarbital sodium Prescription Only Medicine Cats Cattle Chickens Chinchilla Dogs Gerbil Guinea pig Hamster Hare Mink Mouse Ornamental birds Pigeons Pigs Polecat Rat Reptiles Horse (non-food producing) Rabbit (non-food-producing) Neurological Preparations VPA1717/001/001 VPA1717/001/001 Evoctin 10 mg/ml solution for injection for cattle, sheep, pigs ADOH B.V. 11/10/2024 VM Unknown AU Solution for injection QP54AA01 Generic application (Article 18 of Regulation (EU) 2019/6) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA1717/003/001 VPA1717/003/001 Evoctin Plus ADOH B.V. 14/03/2025 VM Unknown AU Solution for injection QP54AA51 Generic application (Article 18 of Regulation (EU) 2019/6) Subcutaneous use Ivermectin Clorsulon Prescription Only Medicine Cattle Endectoparasiticides VPA10987/138/003 VPA10987/138/003 Exidot 100 mg Spot-on solution for Medium Dogs Chanelle Pharmaceuticals Manufacturing Limited 15/11/2019 VM AU Spot-on solution QP53AX17 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA10987/138/004 VPA10987/138/004 Exidot 250 mg Spot-on solution for Large Dogs Chanelle Pharmaceuticals Manufacturing Limited 15/11/2019 VM AU Spot-on solution QP53AX17 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA10987/138/001 VPA10987/138/001 Exidot 40 mg Spot-on solution for Small Cats, Small Pet Rabbits & Small Dogs Chanelle Pharmaceuticals Manufacturing Limited 15/11/2019 VM AU Spot-on solution QP53AX17 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Prescription Only Medicine Cats Dogs Rabbits Ectoparasiticide VPA10987/138/005 VPA10987/138/005 Exidot 400 mg Spot-on solution for Extra Large Dogs Chanelle Pharmaceuticals Manufacturing Limited 15/11/2019 VM AU Spot-on solution QP53AX17 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Prescription Only Medicine Dogs Ectoparasiticide VPA10987/138/002 VPA10987/138/002 Exidot 80 mg Spot-on solution for Large Cats and Large Pet Rabbits Chanelle Pharmaceuticals Manufacturing Limited 15/11/2019 VM AU Spot-on solution QP53AX17 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Prescription Only Medicine Cats Rabbits Ectoparasiticide VPA10987/103/001 VPA10987/103/001 Exitel 230/20 mg Flavoured Film-Coated Tablets for Cats Chanelle Pharmaceuticals Manufacturing Limited 04/07/2013 VM Unknown AU Film-coated tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pyrantel embonate Praziquantel Companion Animal Medicine Cats Endoparasiticide VPA10987/078/001 VPA10987/078/001 Exitel Plus Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 20/03/2009 VM Unknown AU Tablet QP52AA51 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10987/078/002 VPA10987/078/002 Exitel Plus XL Tablets For Dogs Chanelle Pharmaceuticals Manufacturing Limited 02/03/2012 VM Not marketed AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA22033/018/001 VPA22033/018/001 Exodus Oral Paste Bimeda Animal Health Limited 03/10/2003 VM Not marketed AU Oral paste QP52AF02 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Oral use Pyrantel embonate Prescription Only Medicine Horses Endoparasiticide VPA22033/019/001 VPA22033/019/001 Ezeepour 2.5% w/v Pour on Solution Bimeda Animal Health Limited 01/10/1999 VM Unknown AU Pour-on solution QP53AC08 Informed consent (abridged application) - Council Directive 81/851/EEC Pour-on use Cypermethrin technical (93%) (cis: trans 50:50) Prescription Only Medicine Cattle Ectoparasiticide VPA22033/020/001 VPA22033/020/001 Fasifree 100 mg/ml Oral Suspension Bimeda Animal Health Limited 22/02/2002 VM Unknown AU Oral suspension QP52AC01 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Triclabendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA22020/003/001 VPA22020/003/001 Fasinex 240 mg/ml oral suspension for cattle Elanco GmbH 05/09/2008 VM Unknown AU Oral suspension QP52AC01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Triclabendazole Prescription Only Medicine Cattle Endoparasiticide VPA10836/011/001 VPA10836/011/001 Fatrobendan 1.25 mg, chewable tablets for dogs FATRO S.p.A. 19/03/2021 VM Marketed AU Chewable tablet QC01CE90 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10836/011/003 VPA10836/011/003 Fatrobendan 10 mg, chewable tablets for dogs FATRO S.p.A. 19/03/2021 VM Marketed AU Chewable tablet QC01CE90 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10836/011/002 VPA10836/011/002 Fatrobendan 5 mg, chewable tablets for dogs FATRO S.p.A. 19/03/2021 VM Marketed AU Chewable tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10836/012/001 VPA10836/012/001 Fatroseal 2.6 g intramammary suspension for dry cows FATRO S.p.A. 01/04/2022 VM Unknown AU Intramammary suspension QG52X Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Bismuth subnitrate, heavy Licensed Retailer Cattle Miscellaneous VPA22622/009/003 VPA22622/009/003 Felimazole 1.25 mg Coated tablets for cats Dechra Regulatory B.V. 13/09/2013 VM Unknown AU Coated tablet QH03BB02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Thiamazole Prescription Only Medicine Cats Hormone VPA22622/009/001 VPA22622/009/001 Felimazole 2.5 mg Coated Tablets for Cats Dechra Regulatory B.V. 20/02/2009 VM Unknown AU Coated tablet QH03BB02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Thiamazole Prescription Only Medicine Cats Hormone VPA22622/009/004 VPA22622/009/004 Felimazole 5 mg/ml oral solution for cats Dechra Regulatory B.V. 06/10/2023 VM Unknown AU Oral solution QH03BB02 Full application - known active substance (Article 8 of Regulation (EU) 2019/6) Oral use Thiamazole Prescription Only Medicine Cats Hormone VPA22622/009/002 VPA22622/009/002 Felimazole 5 mg Coated Tablets for Cats Dechra Regulatory B.V. 28/11/2008 VM Unknown AU Coated tablet QH03BB02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Thiamazole Prescription Only Medicine Cats Hormone VPA10987/186/001 VPA10987/186/001 Felipex 5 mg/ml oral solution Chanelle Pharmaceuticals Manufacturing Limited 17/07/2026 VM Unknown AU Oral solution QH03BB02 Hybrid application – change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Thiamazole Prescription Only Medicine Cats Hormone VPA10462/003/001 VPA10462/003/001 Fenafluke 5% w/v Oral Suspension Pharvet (Ireland) Limited 18/09/1998 VM Unknown AU Oral suspension QP52AC13 QP52AX Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Fenbendazole Rafoxanide Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10915/002/001 VPA10915/002/001 Fenben 10 Oral Suspension Ancare Ireland Ltd. 10/02/1994 VM Unknown AU Oral suspension QP52AC13 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Fenbendazole Prescription Only Medicine Cattle Endoparasiticide VPA10462/002/001 VPA10462/002/001 Fenbenor 100 mg/ml oral drench for cattle Pharvet (Ireland) Limited 26/07/1991 VM Unknown AU Oral suspension QP52AC13 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Fenbendazole Prescription Only Medicine Cattle Endoparasiticide VPA10462/002/002 VPA10462/002/002 Fenbenor 25 mg/ml oral drench for sheep Pharvet (Ireland) Limited 04/08/1992 VM Unknown AU Oral suspension QP52AC13 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Fenbendazole Prescription Only Medicine Sheep Endoparasiticide VPA10454/080/001 VPA10454/080/001 Fencovis Boehringer Ingelheim Vetmedica GmbH 19/08/2022 VM Marketed AU Suspension for injection QI02AL01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Escherichia coli, strain 08:K35, fimbrial adhesin F5, Inactivated Bovine rotavirus, strain TM-91, Inactivated Bovine coronavirus strain c-197 (inactivated) Prescription Only Medicine Cattle Immunological - Inactivated Vaccine VPA10774/010/001 VPA10774/010/001 Fenflor 300 mg/ml solution for injection for cattle Krka, d.d., Novo mesto 03/09/2010 VM Unknown AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Florfenicol Prescription Only Medicine Cattle Antibacterial VPA10774/009/001 VPA10774/009/001 Fenflor 300 mg/ml solution for injection for pigs Krka, d.d., Novo mesto 26/09/2008 VM Unknown AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Florfenicol Prescription Only Medicine Pigs Antibacterial VPA10987/072/002 VPA10987/072/002 Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs Chanelle Pharmaceuticals Manufacturing Limited 14/05/2010 VM Unknown AU Solution for injection QJ01MA90 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10987/072/001 VPA10987/072/001 Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats Chanelle Pharmaceuticals Manufacturing Limited 14/05/2010 VM Unknown AU Solution for injection QJ01MA90 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cats Cattle Dogs Pigs Antibacterial VPA10987/148/001 VPA10987/148/001 Fermectin 1 % Solution for Injection for Pigs Chanelle Pharmaceuticals Manufacturing Limited 20/06/2001 VM Not marketed AU Solution for injection QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Pigs Endectoparasiticides VPA10516/016/001 VPA10516/016/001 Fertigest 0.004 mg/ml Solution for Injection Vetpharma Animal Health S.L. 01/09/2017 VM Unknown AU Solution for injection QH01CA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Buserelin acetate Prescription Only Medicine Cattle Horses Pigs Rabbits Hormone VPA10509/024/002 VPA10509/024/002 Ficoxil 227 mg chewable tablets for dogs Industrial Veterinaria S.A. 18/06/2021 VM Unknown AU Chewable tablet QM01AH90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Firocoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10509/024/001 VPA10509/024/001 Ficoxil 57 mg chewable tablets for dogs Industrial Veterinaria S.A. 18/06/2021 VM Unknown AU Chewable tablet QM01AH90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Firocoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10996/228/001 VPA10996/228/001 Finadyne, 50 mg/ml, solution for Injection Intervet Ireland Limited 02/03/2012 VM Unknown AU Solution for injection QM01AG90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Flunixin Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10475/015/001 VPA10475/015/001 Finilac 50 microgram/ml oral solution for dogs and cats Le Vet Beheer B.V. 10/07/2015 VM Unknown AU Oral solution QG02CB03 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cabergoline Prescription Only Medicine Cats Dogs Hormone VPA10987/095/002 VPA10987/095/002 Fipnil 134 mg Spot-on Solution for medium dogs Chanelle Pharmaceuticals Manufacturing Limited 03/02/2012 VM Not marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10987/095/003 VPA10987/095/003 Fipnil 268 mg Spot-on Solution for large dogs Chanelle Pharmaceuticals Manufacturing Limited 03/02/2012 VM Not marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10987/095/004 VPA10987/095/004 Fipnil 402 mg Spot-on Solution for extra large dogs Chanelle Pharmaceuticals Manufacturing Limited 03/02/2012 VM Not marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10987/096/001 VPA10987/096/001 Fipnil 50 mg Spot-on solution for Cats Chanelle Pharmaceuticals Manufacturing Limited 03/02/2012 VM Not marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Cats Ectoparasiticide VPA10987/095/001 VPA10987/095/001 Fipnil 67 mg Spot-on Solution for small dogs Chanelle Pharmaceuticals Manufacturing Limited 03/02/2012 VM Not marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA20742/005/001 VPA20742/005/001 FIPREX DUO 50 mg+ 60 mg spot-on solution for cats and ferrets Vet-Agro Multi-Trade Company Sp z o.o. 06/03/2020 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-methopene Prescription Only Medicine Cats Ferrets Ectoparasiticide VPA20742/004/003 VPA20742/004/003 Fiprex Duo L 268 mg + 241.2 mg spot-on solution for dogs Vet-Agro Multi-Trade Company Sp z o.o. 06/03/2020 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use (S)-Methoprene Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA20742/004/002 VPA20742/004/002 Fiprex Duo M 134 mg + 120.6 mg spot-on solution for dogs Vet-Agro Multi-Trade Company Sp z o.o. 06/03/2020 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use (S)-Methoprene Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA20742/004/001 VPA20742/004/001 FIPREX DUO S 67 mg + 60.3 mg spot-on solution for dogs Vet-Agro Multi-Trade Company Sp z o.o. 06/03/2020 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use (S)-Methoprene Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA20742/004/004 VPA20742/004/004 Fiprex Duo XL 402 mg + 361.8 mg spot-on solution for dogs Vet-Agro Multi-Trade Company Sp z o.o. 06/03/2020 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use (S)-Methoprene Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/107/002 VPA22664/107/002 Fiproclear 134 mg Spot-On Solution for Medium Dogs Norbrook Laboratories (Ireland) Limited 17/05/2013 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/107/003 VPA22664/107/003 Fiproclear 268 mg Spot-On Solution for Large Dogs Norbrook Laboratories (Ireland) Limited 17/05/2013 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/107/004 VPA22664/107/004 Fiproclear 402 mg Spot-On Solution for Very Large Dogs Norbrook Laboratories (Ireland) Limited 17/05/2013 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/108/001 VPA22664/108/001 Fiproclear 50 mg Spot-On Solution for Cats Norbrook Laboratories (Ireland) Limited 17/05/2013 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Cats Ectoparasiticide VPA22664/107/001 VPA22664/107/001 Fiproclear 67 mg Spot-On Solution for Small Dogs Norbrook Laboratories (Ireland) Limited 17/05/2013 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/137/002 VPA22664/137/002 Fiproclear Combo 134 mg/120.6 mg spot-on solution for medium dogs Norbrook Laboratories (Ireland) Limited 13/04/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-methopene Licensed Retailer Dogs Ectoparasiticide VPA22664/137/003 VPA22664/137/003 Fiproclear Combo 268 mg/241.2 mg spot-on solution for large dogs Norbrook Laboratories (Ireland) Limited 13/04/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-methopene Licensed Retailer Dogs Ectoparasiticide VPA22664/137/004 VPA22664/137/004 Fiproclear Combo 402 mg/361.8 mg spot-on solution for very large dogs Norbrook Laboratories (Ireland) Limited 13/04/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-methopene Licensed Retailer Dogs Ectoparasiticide VPA22664/134/001 VPA22664/134/001 Fiproclear Combo 50 mg/60 mg spot-on solution for cats and ferrets Norbrook Laboratories (Ireland) Limited 13/04/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-methopene Licensed Retailer Cats Ferrets Ectoparasiticide VPA22664/137/001 VPA22664/137/001 Fiproclear Combo 67 mg/60.3 mg spot-on solution for small dogs Norbrook Laboratories (Ireland) Limited 13/04/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-methopene Licensed Retailer Dogs Ectoparasiticide VPA10815/057/002 VPA10815/057/002 Firodyl 250 mg chewable tablets for dogs Ceva Santé Animale 17/01/2020 VM Unknown AU Chewable tablet QM01AH90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Firocoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10815/057/001 VPA10815/057/001 Firodyl 62.5 mg chewable tablets for dogs Ceva Santé Animale 17/01/2020 VM Unknown AU Chewable tablet QM01AH90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Firocoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA23174/002/001 VPA23174/002/001 Fixplan 200 IU/ml lyophilisate and solvent for solution for injection Syn Vet-Pharma Ireland Limited 05/03/2021 VM Unknown AU Lyophilisate and solvent for solution for injection QG03GA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Gonadotrophin, Equine Serum, For Veterinary Use Prescription Only Medicine Cattle Pigs Sheep Hormone VPA22664/136/002 VPA22664/136/002 Fleanil Combo 134 mg/120.6 mg spot-on solution for medium dogs Norbrook Laboratories (Ireland) Limited 26/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil S-methoprene Licensed Retailer Dogs Ectoparasiticide VPA22664/136/003 VPA22664/136/003 Fleanil Combo 268 mg/241.2 mg spot-on solution for large dogs Norbrook Laboratories (Ireland) Limited 26/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-methopene Licensed Retailer Dogs Ectoparasiticide VPA22664/136/004 VPA22664/136/004 Fleanil Combo 402 mg/361.8 mg spot-on solution for very large dogs Norbrook Laboratories (Ireland) Limited 26/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil S-methoprene Licensed Retailer Dogs Ectoparasiticide VPA22664/132/001 VPA22664/132/001 Fleanil Combo 50 mg/60 mg spot-on solution for cats and ferrets Norbrook Laboratories (Ireland) Limited 26/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Cats Ferrets Ectoparasiticide VPA22664/136/001 VPA22664/136/001 Fleanil Combo 67 mg/60.3 mg spot-on solution for small dogs Norbrook Laboratories (Ireland) Limited 26/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Dogs Ectoparasiticide VPA10987/106/002 VPA10987/106/002 Fleaway 134 mg Spot-on Solution for medium dogs Chanelle Pharmaceuticals Manufacturing Limited 07/02/2014 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Licensed Retailer Dogs Ectoparasiticide VPA10987/106/003 VPA10987/106/003 Fleaway 268 mg Spot-on Solution for large dogs Chanelle Pharmaceuticals Manufacturing Limited 07/02/2014 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Licensed Retailer Dogs Ectoparasiticide VPA10987/106/004 VPA10987/106/004 Fleaway 402 mg Spot-on Solution for extra large dogs Chanelle Pharmaceuticals Manufacturing Limited 07/02/2014 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Licensed Retailer Dogs Ectoparasiticide VPA10987/105/001 VPA10987/105/001 Fleaway 50 mg Spot on solution for cats Chanelle Pharmaceuticals Manufacturing Limited 07/02/2014 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Licensed Retailer Cats Ectoparasiticide VPA10987/106/001 VPA10987/106/001 Fleaway 67 mg Spot-on Solution for small dogs Chanelle Pharmaceuticals Manufacturing Limited 07/02/2014 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Licensed Retailer Dogs Ectoparasiticide VPA10987/106/008 VPA10987/106/008 Fleaway Plus 134 mg/120.6 mg Spot-on Solution for Medium Dogs Chanelle Pharmaceuticals Manufacturing Limited 10/01/2020 VM AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Companion Animal Medicine Dogs Ectoparasiticide VPA10987/106/007 VPA10987/106/007 Fleaway Plus 268 mg/241.2 mg Spot-on Solution for Large Dogs Chanelle Pharmaceuticals Manufacturing Limited 10/01/2020 VM AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Companion Animal Medicine Dogs Ectoparasiticide VPA10987/106/006 VPA10987/106/006 Fleaway Plus 402 mg/361.8 mg Spot-on Solution for Extra Large Dogs Chanelle Pharmaceuticals Manufacturing Limited 10/01/2020 VM AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Companion Animal Medicine Dogs Ectoparasiticide VPA10987/106/009 VPA10987/106/009 Fleaway Plus 50 mg/60 mg Spot-on Solution for Cats and Ferrets Chanelle Pharmaceuticals Manufacturing Limited 10/01/2020 VM AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Companion Animal Medicine Cats Ferrets Ectoparasiticide VPA10987/106/005 VPA10987/106/005 Fleaway Plus 67 mg/60.3 mg Spot-on Solution for Small Dogs Chanelle Pharmaceuticals Manufacturing Limited 10/01/2020 VM AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Companion Animal Medicine Dogs Ectoparasiticide VPA10387/034/001 VPA10387/034/001 Flectron Fly Tags 935 mg Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Ear tag QP53AC08 Full application (Article 12(3) of Directive No 2001/82/EC) Cutaneous use Cypermethrin Prescription Only Medicine Cattle Ectoparasiticide VPA22033/021/001 VPA22033/021/001 Flexiben 100 mg/ml SC Oral Suspension for Cattle and Sheep Bimeda Animal Health Limited 27/06/1997 VM Unknown AU Oral suspension QP52AC11 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Albendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10774/015/001 VPA10774/015/001 FLIMABEND 100 mg/g suspension for use in drinking water for chickens and pigs Krka, d.d., Novo mesto 27/03/2013 VM Not marketed AU Oral suspension QP52AC12 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Oral use Flubendazole Prescription Only Medicine Chickens Pigs Endoparasiticide VPA10791/006/001 VPA10791/006/001 Flordofen 300 mg/ml Solution for injection for cattle and pigs Dopharma Research B.V. 28/03/2014 VM Unknown AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Florfenicol Prescription Only Medicine Cattle Pigs Antibacterial VPA10981/013/001 VPA10981/013/001 FLORFENIKEL 300 mg/ml solution for injection for cattle and pigs Kela n.v. 24/02/2012 VM Unknown AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Florfenicol Prescription Only Medicine Cattle Pigs Antibacterial VPA10495/007/001 VPA10495/007/001 FLORFENIS 300 mg/ml solution for injection for cattle, sheep and pigs Laboratorios Syva S.A. 12/02/2021 VM Unknown AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Florfenicol Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10534/001/001 VPA10534/001/001 Florgane 300 mg/ml Suspension for Injection for Cattle and Pigs Emdoka 13/08/2010 VM Unknown AU Suspension for injection QJ01BA90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Florfenicol Prescription Only Medicine Cattle Pigs Antibacterial VPA10665/006/001 VPA10665/006/001 FLORINJECT 300 mg/ml solution for injection for cattle and pigs LABORATORIOS CALIER S.A. 27/09/2013 VM Not marketed AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Florfenicol Prescription Only Medicine Cattle Pigs Antibacterial VPA10815/008/001 VPA10815/008/001 Florkem 300 mg/ml solution for injection for cattle and pigs Ceva Santé Animale 28/08/2009 VM Unknown AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Florfenicol Prescription Only Medicine Cattle Pigs Antibacterial VPA10402/003/001 VPA10402/003/001 FLOROLAB 100 mg/ml solution for use in drinking water for pigs Labiana Life Sciences, S.A. 23/08/2019 VM Unknown AU Solution for use in drinking water QJ01BA90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Florfenicol Prescription Only Medicine Pigs Antibacterial VPA10786/009/001 VPA10786/009/001 Flortekxin 300 mg/ml + 16.5 mg/ml solution for injection for cattle Laboratorios Karizoo S.A. 28/03/2024 VM Unknown AU Solution for injection QJ01BA99 Generic application (Article 18 of Regulation (EU) 2019/6) Subcutaneous use Florfenicol Flunixin Prescription Only Medicine Cattle Antibacterial VPA10816/006/001 VPA10816/006/001 Floxabactin 15 mg tablets for cats and dogs Le Vet BV 03/09/2010 VM Unknown AU Tablet QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Cats Dogs Antibacterial VPA10816/006/003 VPA10816/006/003 Floxabactin 150 mg tablets for dogs Le Vet BV 03/09/2010 VM Unknown AU Tablet QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Dogs Antibacterial VPA10816/006/002 VPA10816/006/002 Floxabactin 50 mg tablets for dogs Le Vet BV 03/09/2010 VM Unknown AU Tablet QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Dogs Antibacterial VPA10790/002/001 VPA10790/002/001 Floxamax 100 mg/ml concentrate for oral solution for chickens and turkeys SP Veterinaria, S.A. 07/03/2008 VM Marketed AU Oral solution QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Chickens Turkeys Antibacterial VPA10987/071/002 VPA10987/071/002 Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs Chanelle Pharmaceuticals Manufacturing Limited 16/07/2010 VM Not marketed AU Solution for injection QJ01MA90 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10987/071/001 VPA10987/071/001 Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats Chanelle Pharmaceuticals Manufacturing Limited 16/07/2010 VM Not marketed AU Solution for injection QJ01MA90 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cats Cattle Dogs Pigs Antibacterial VPA22020/037/001 VPA22020/037/001 Flubendazole Elanco 50 mg/g oral powder for pigs Elanco GmbH 22/02/2013 VM Unknown AU Oral powder QP52AC12 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Flubendazole Prescription Only Medicine Pigs Endoparasiticide VPA22020/028/001 VPA22020/028/001 Flubenol 50 mg/g Oral Powder Elanco GmbH 06/07/2012 VM Unknown AU Oral powder QP52AC12 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Flubendazole Prescription Only Medicine Pigs Endoparasiticide VPA22020/006/001 VPA22020/006/001 Flubenol 50 mg/g Premix for Medicated Feeding Stuff Elanco GmbH 25/05/2012 VM Unknown AU Premix for medicated feeding stuff QP52AC12 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Flubendazole Prescription Only Medicine Chickens Goose Partridge Pheasants Pigs Turkeys Endoparasiticide VPA22622/036/001 VPA22622/036/001 Fluboral 200 mg/ml, suspension for use in drinking water for pigs and chickens Dechra Regulatory B.V. 05/05/2023 VM Unknown AU Suspension for use in drinking water QP52AC12 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Flubendazole Prescription Only Medicine Chickens Pigs Endoparasiticide VPA10791/017/001 VPA10791/017/001 Fludosol 200 mg/ml Suspension for use in drinking water for pigs and chickens Dopharma Research B.V. 30/06/2023 VM Unknown AU Suspension for use in drinking water QP52AC12 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Flubendazole Prescription Only Medicine Chickens Pigs Endoparasiticide VPA22020/001/001 VPA22020/001/001 Flukiver 50 mg/ml Oral Suspension for sheep and lambs Elanco GmbH 18/01/2013 VM Unknown AU Oral suspension QP52AG09 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Closantel sodium Prescription Only Medicine Sheep Endoparasiticide VPA22020/039/001 VPA22020/039/001 Flukiver Combi 50 mg/ml + 75 mg/ml oral suspension Elanco GmbH 08/06/2012 VM Not marketed AU Oral suspension QP52A Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Closantel sodium dihydrate Mebendazole Prescription Only Medicine Sheep Endoparasiticide VPA22033/061/001 VPA22033/061/001 Flunazine 50 mg/ml Solution for Injection for cattle, horses and pigs Bimeda Animal Health Limited 27/07/2001 VM Temporarily Not Marketed AU Solution for injection QM01AG90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Intramuscular use Flunixin meglumine Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10509/009/001 VPA10509/009/001 Flunex 50 mg/ml solution for injection for cattle, horses and pigs Industrial Veterinaria S.A. 19/07/2024 VM Unknown AU Solution for injection QM01AG90 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Flunixin meglumine Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA22664/046/001 VPA22664/046/001 Flunixin Injection Norbrook Laboratories (Ireland) Limited 23/04/1997 VM Unknown AU Solution for injection QM01AG90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Flunixin meglumine Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA23340/009/001 VPA23340/009/001 Fluoxevet 32 mg, tablets for dogs Domes Pharma 02/08/2024 VM Unknown AU Tablet QN06AB03 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use FLUOXETINE HYDROCHLORIDE Prescription Only Medicine Dogs Neurological Preparations VPA10387/048/001 VPA10387/048/001 Fly and Lice Spot On Insecticide 10 mg/ml spot-on solution for cattle and sheep Zoetis Belgium S.A. 04/07/2014 VM Marketed AU Spot-on solution QP53AC11 Full application (Article 12(3) of Directive No 2001/82/EC) Spot-on use Deltamethrin Prescription Only Medicine Cattle Sheep Ectoparasiticide VPA10996/055/001 VPA10996/055/001 Folligon PMSG 200 IU/ml lyophilisate and solvent for solution for injection Intervet Ireland Limited 19/09/1998 VM Unknown AU Lyophilisate and solvent for solution for injection QG03GA03 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Gonadotropin, equine, serum Prescription Only Medicine Cattle Pigs Sheep Hormone VPA10983/050/001 VPA10983/050/001 Folltropin 700 IU Powder and Solvent for solution for injection Vetoquinol Ireland Limited 06/11/2015 VM Unknown AU Powder and solvent for solution for injection QG03GA90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Porcine follicle stimulating hormone Prescription Only Medicine Cattle Hormone VPA10996/232/001 VPA10996/232/001 Footvax Emulsion for Injection for Sheep Intervet Ireland Limited 20/02/2004 VM Unknown AU Emulsion for injection QI04AB03 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Dichelobacter nodosus serotype I Dichelobacter nodosus serotype H Dichelobacter nodosus serotype G Dichelobacter nodosusserotype F Dichelobacter nodosus serotype E Dichelobacter nodosus serotype D Dichelobacter nodosus serotype C Dichelobacter nodosus serotype B2 Dichelobacter nodosus serotype B1 Dichelobacter nodosus serotype A Prescription Only Medicine Sheep Immunological VPA10521/030/001 VPA10521/030/001 Forcyl 160 mg/ml solution for injection for cattle Vetoquinol S.A. 22/07/2011 VM Unknown AU Solution for injection QJ01MA93 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Marbofloxacin Prescription Only Medicine Cattle Antibacterial VPA10983/052/001 VPA10983/052/001 FORCYL swine 160 mg/ml solution for injection for pigs Vetoquinol Ireland Limited 31/08/2012 VM Unknown AU Solution for injection QJ01MA93 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Marbofloxacin Prescription Only Medicine Pigs Antibacterial VPA20742/006/001 VPA20742/006/001 Forespix 100 mg/ml solution for injection for cattle, pigs and sheep Vet-Agro Multi-Trade Company Sp z o.o. 22/01/2021 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Tulathromycin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22670/002/001 VPA22670/002/001 Formicpro 68.2g Beehive Strips for Honey Bees NOD Apiary Ireland Limited 04/06/2021 VM Unknown AU Bee-hive strip QP53AG01 Full application (Article 12(3) of Directive No 2001/82/EC) Inhalation use Formic acid Licensed Retailer Honey bees Ectoparasiticide VPA22020/017/001 VPA22020/017/001 Fortekor 2.5 mg tablets for cats and dogs Elanco GmbH 22/04/2016 VM Unknown AU Tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Cats Dogs Cardiovascular VPA22020/018/002 VPA22020/018/002 Fortekor Flavour 20 mg Tablets for dogs Elanco GmbH 22/04/2016 VM Unknown AU Tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Dogs Cardiovascular VPA22020/018/001 VPA22020/018/001 Fortekor Flavour 5 mg Tablets for cats and dogs Elanco GmbH 22/04/2016 VM Unknown AU Tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Cats Dogs Cardiovascular VPA10915/011/001 VPA10915/011/001 Fortemec 1 % w/v Pour On Solution Ancare Ireland Ltd. 26/01/2001 VM Unknown AU Pour-on solution QP54AA02 Informed consent application (Article 13c of Directive No 2001/82/EC) Pour-on use Abamectin Prescription Only Medicine Cattle Endectoparasiticides VPA10454/046/001 VPA10454/046/001 Frontline Combo Spot-on Cat Boehringer Ingelheim Vetmedica GmbH 14/05/2004 VM Unknown AU Spot-on solution QP53AX65 Not Currently Available Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Cats Ferrets Ectoparasiticide VPA10454/047/003 VPA10454/047/003 Frontline Combo Spot-on Dog L Boehringer Ingelheim Vetmedica GmbH 14/05/2004 VM Unknown AU Spot-on solution QP53AX65 Not Currently Available Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10454/047/002 VPA10454/047/002 Frontline Combo Spot-on Dog M Boehringer Ingelheim Vetmedica GmbH 14/05/2004 VM Unknown AU Spot-on solution QP53AX65 Not Currently Available Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10454/047/001 VPA10454/047/001 Frontline Combo Spot-on Dog S Boehringer Ingelheim Vetmedica GmbH 14/05/2004 VM Unknown AU Spot-on solution QP53AX65 Not Currently Available Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10454/047/004 VPA10454/047/004 Frontline Combo Spot-on Dog XL Boehringer Ingelheim Vetmedica GmbH 14/05/2004 VM Unknown AU Spot-on solution QP53AX65 Not Currently Available Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10454/048/001 VPA10454/048/001 Frontline Spot On Cat Boehringer Ingelheim Vetmedica GmbH 12/06/1998 VM Not marketed AU Spot-on solution QP53AX15 Full application (Article 12(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Cats Ectoparasiticide VPA10454/049/001 VPA10454/049/001 Frontline Spot On Dog Boehringer Ingelheim Vetmedica GmbH 12/06/1998 VM Not marketed AU Spot-on solution QP53AX15 Full application (Article 12(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10454/050/001 VPA10454/050/001 Frontline Spray 0.25 w/v Boehringer Ingelheim Vetmedica GmbH 07/07/1995 VM Unknown AU Cutaneous spray, solution QP53AX15 Full application (Article 12(3) of Directive No 2001/82/EC) Cutaneous use Fipronil Prescription Only Medicine Cats Dogs Ectoparasiticide VPA10810/024/001 VPA10810/024/001 Fugasol 10 mg/ml oral solution for cats CP-Pharma Handelsgesellschaft mbH 16/12/2022 VM Unknown AU Oral solution QJ02AC02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Itraconazole Prescription Only Medicine Cats Antifungal VPA22622/047/001 VPA22622/047/001 Fungiconazol 200 mg tablets for dogs Dechra Regulatory B.V. 14/11/2014 VM Unknown AU Tablet QJ02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Ketoconazole Prescription Only Medicine Dogs Antifungal VPA22622/047/002 VPA22622/047/002 Fungiconazol 400 mg tablets for dogs Dechra Regulatory B.V. 14/11/2014 VM Unknown AU Tablet QJ02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Ketoconazole Prescription Only Medicine Dogs Antifungal VPA10475/017/001 VPA10475/017/001 Furosoral 10 mg tablets for cats and dogs Le Vet Beheer B.V. 20/02/2015 VM Unknown AU Tablet QC03CA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Furosemide Prescription Only Medicine Cats Dogs Cardiovascular VPA10475/017/002 VPA10475/017/002 Furosoral 40 mg tablets for cats and dogs Le Vet Beheer B.V. 20/02/2015 VM Unknown AU Tablet QC03CA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Furosemide Prescription Only Medicine Cats Dogs Cardiovascular VPA22664/147/001 VPA22664/147/001 Fuselieve 1 mg/g + 5 mg/g Gel for Dogs Norbrook Laboratories (Ireland) Limited 15/03/2019 VM Unknown AU Gel QD07CC01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Cutaneous use Betamethasone valerate Fusidic acid hemihydrate Prescription Only Medicine Dogs Antibacterial VPA10815/050/001 VPA10815/050/001 Gabbrovet 140 mg/ml solution for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs Ceva Santé Animale 13/04/2018 VM Unknown AU Solution for use in drinking water/milk QA07AA06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Paromomycin Prescription Only Medicine Cattle Pigs Antibacterial VPA10815/066/001 VPA10815/066/001 Gabbrovet Multi 140 mg/ml solution for use in drinking water/milk Ceva Santé Animale 02/09/2022 VM Unknown AU Solution for use in drinking water/milk QA07AA06 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Paromomycin Prescription Only Medicine Cattle Pigs Antibacterial VPA10509/010/001 VPA10509/010/001 Galapan 75 micrograms/ml solution for injection for cattle, horses and pigs Industrial Veterinaria S.A. 01/08/2025 VM Unknown AU Solution for injection QG02AD90 Informed Consent application (Article 21 of Regulation (EU) 2019/6) Intramuscular use D-cloprostenol sodium salt Prescription Only Medicine Cattle Horses Pigs Hormone VPA10782/030/001 VPA10782/030/001 Gallifen 200 mg/ml suspension for use in drinking water for chickens and pheasants Huvepharma NV 29/03/2018 VM Unknown AU Suspension for use in drinking water QP52AC13 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Fenbendazole Prescription Only Medicine Chickens Pheasants Endoparasiticide VPA10782/022/001 VPA10782/022/001 Gallifen 40 mg/g premix for medicated feeding stuff for chickens and pheasants Huvepharma NV 20/01/2017 VM Unknown AU Premix for medicated feeding stuff QP52AC13 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In-feed use Fenbendazole Prescription Only Medicine Chickens Pheasants Endoparasiticide VPA10454/053/001 VPA10454/053/001 GALLIMUNE 407 ND+IB+EDS+ART Emulsion for injection Boehringer Ingelheim Vetmedica GmbH 25/11/2005 VM Not marketed AU Emulsion for injection QI01AA18 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated newcastle disease virus, ulser 2C strain, at least Inactivated infectious bronchitis virus, mass41 strain, at least Inactivated egg drop syndrome virus (EDS76), V127 strain, at least Inactivated avian rhinotracheitis virus (swollen head syndrome), vc03 strain, at least Prescription Only Medicine Chickens Immunological - Inactivated Vaccine VPA10454/054/001 VPA10454/054/001 Gallimune Se + St, water-in-oil emulsion for injection Boehringer Ingelheim Vetmedica GmbH 22/06/2007 VM Not marketed AU Emulsion for injection QI01AB01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated Salmonella Enteritidis PT4 Inactivated Salmonella Typhimurium DT 104 Prescription Only Medicine Chickens Immunological - Inactivated Vaccine VPA10454/056/001 VPA10454/056/001 GALLIVAC IB88 NEO effervescent tablet for suspension for nebulisation for chickens Boehringer Ingelheim Vetmedica GmbH 19/02/2016 VM Unknown AU Effervescent tablet QI01AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Nebulisation use Live attenuated coronavirus, CR88121 strain Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10454/079/001 VPA10454/079/001 Gallivac IBD S706 NEO Effervescent tablet for use in drinking water for chickens Boehringer Ingelheim Vetmedica GmbH 08/01/2021 VM Unknown AU Effervescent tablet QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Infectious bursal disease virus, attenuated strain S706 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10782/023/001 VPA10782/023/001 GalluDoxx 500 mg/g powder for use in drinking water/milk replacer for calves, chickens and turkeys Huvepharma NV 10/02/2017 VM Unknown AU Powder for use in drinking water QJ01AA02 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Doxycycline hyclate Prescription Only Medicine Cattle Chickens Turkeys Antibacterial VPA22033/084/001 VPA22033/084/001 Gamrozyne 150 mg/ml Solution for Injection for Cattle, Sheep and Pigs Bimeda Animal Health Limited 13/09/2024 VM Unknown AU Solution for injection QJ01FA95 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Subcutaneous use Gamithromycin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10987/124/001 VPA10987/124/001 Gastazole 370 mg/g oral paste for horses Chanelle Pharmaceuticals Manufacturing Limited 15/05/2020 VM Unknown AU Oral paste QA02BC01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Omeprazole Prescription Only Medicine Horses Alimentary Tract Preparation VPA22033/072/001 VPA22033/072/001 Gastrobim 370 mg/g oral paste for horses Bimeda Animal Health Limited 09/10/2020 VM Unknown AU Oral paste QA02BC01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Omeprazole Prescription Only Medicine Horses Alimentary Tract Preparation VPA10454/058/001 VPA10454/058/001 GastroGard 370 mg/g oral paste Boehringer Ingelheim Vetmedica GmbH 19/11/2004 VM Unknown AU Oral paste QA02BC01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Omeprazole Prescription Only Medicine Horses Alimentary Tract Preparation VPA10664/009/001 VPA10664/009/001 Geepenil vet 6.36 g powder for solution for injection Orion Corporation 17/04/2026 VM Unknown AU Powder for solution for injection QJ01CE01 Generic application (Article 18 of Regulation (EU) 2019/6) Intravenous use Benzylpenicillin Sodium Prescription Only Medicine Horses Antibacterial VPA10391/003/001 VPA10391/003/001 GEFRIDERM cutaneous spray solution for dogs Alphavet Zrt. 23/04/2021 VM Unknown AU Cutaneous spray, solution QD07CA03 Full application (Article 12(3) of Directive No 2001/82/EC) Cutaneous use Marbofloxacin Ketoconazole Prednisolone Prescription Only Medicine Dogs Antibacterial VPA10915/007/001 VPA10915/007/001 Genesis 1% Pour-on Solution Ancare Ireland Ltd. 20/12/2000 VM Unknown AU Pour-on solution QP54AA Complete application (stand-alone) - Council Directive 81/851/EEC Pour-on use Abamectin Prescription Only Medicine Cattle Endectoparasiticides VPA10915/009/001 VPA10915/009/001 Genesis Sheep Drench 0.8 mg/ml abamectin oral solution Ancare Ireland Ltd. 17/12/2004 VM Unknown AU Oral solution QP54AA02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Abamectin Prescription Only Medicine Sheep Endectoparasiticides VPA10826/010/001 VPA10826/010/001 Genestran 75 micrograms/ml solution for injection for cattle, horses and pigs aniMedica GmbH 09/10/2009 VM Marketed AU Solution for injection QG02AD90 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramuscular use D-cloprostenol sodium salt Prescription Only Medicine Cattle Horses Pigs Hormone VPA10981/011/001 VPA10981/011/001 Genta 50 mg/ml solution for injection Kela n.v. 01/10/2003 VM Unknown AU Solution for injection QJ01GB03 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Gentamicin sulfate Prescription Only Medicine Cattle Antibacterial VPA10445/008/001 VPA10445/008/001 GentaDug 85 mg/ml solution for injection for horses, cattle, pigs, dogs and cats Bela-Pharm GmbH & Co. KG 04/08/2023 VM Unknown AU Solution for injection QJ01GB03 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Subcutaneous use Gentamicin sulfate Prescription Only Medicine Cats Cattle Dogs Horses Pigs Antibacterial VPA10976/002/001 VPA10976/002/001 Gentaject 10% Solution for Injection for Horses Franklin Pharmaceuticals Ltd. 01/10/1988 VM Unknown AU Solution for injection QJ01GB03 Full application (Article 12(3) of Directive No 2001/82/EC) Intravenous use Gentamicin sulfate Prescription Only Medicine Horses Horse (non-food producing) Antibacterial VPA23501/001/001 VPA23501/001/001 GESTAVET OXYTOCIN 10 IU/ml Synthetic Oxytocin, solution for injection Biogenesis Global S.L. 01/09/2000 VM Unknown AU Solution for injection QH01BB02 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Intramuscular use Intravenous use Oxytocin synthetic Prescription Only Medicine Cats Cattle Dogs Pigs Sheep Hormone VPA10402/001/001 VPA10402/001/001 Gleptoferron Labiana 200 mg/ml Solution for Injection Labiana Life Sciences, S.A. 23/12/2016 VM Unknown AU Solution for injection QB03AC91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Gleptoferron Licensed Retailer Pigs Vitamins and minerals VPA10402/006/001 VPA10402/006/001 Gleptolab 200 mg/ml Solution for Injection for pigs Labiana Life Sciences, S.A. 14/08/2023 VM Unknown AU Solution for injection QB03AC Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Iron (as gleptoferron) Licensed Retailer Pigs Vitamins and minerals VPA10815/027/001 VPA10815/027/001 Gleptosil 200 mg/ml Solution for Injection Ceva Santé Animale 29/05/2015 VM Unknown AU Solution for injection QB03AC91 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Gleptoferron Licensed Retailer Pigs Vitamins and minerals VPA10790/010/001 VPA10790/010/001 GLEPTOVEX 200 mg/ml solution for injection for pigs SP Veterinaria, S.A. 02/12/2016 VM Unknown AU Solution for injection QB03AC91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Gleptoferron Licensed Retailer Pigs Vitamins and minerals VPA10387/035/001 VPA10387/035/001 GLETVAX 6 Zoetis Belgium S.A. 29/08/2013 VM Unknown AU Suspension for injection QI09AB08 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Purified toxoids of Cl. perfringens Escherichia coli, fimbrial adhesin F4ac Escherichia coli, fimbrial adhesin F4ab Escherichia coli, fimbrial adhesin F5 Escherichia coli, fimbrial adhesin F6 Licensed Retailer Pigs Immunological - Inactivated Vaccine VPA22633/001/001 VPA22633/001/001 Glucadex 2 mg/ml solution for injection for horses, cattle, goats, pigs, dogs and cats Kepro B.V. 14/02/2020 VM Unknown AU Solution for injection QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intraarticular use Intramuscular use Intravenous use Periarticular use Subcutaneous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Corticosteroid VPA10445/009/001 VPA10445/009/001 Glucobel 40 g/100 ml solution for infusion for horses, cattle, sheep, goats, pigs, dogs and cats Bela-Pharm GmbH & Co. KG 25/11/2022 VM Unknown AU Solution for infusion QB05BA03 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Intravenous use Glucose monohydrate Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Sheep Miscellaneous VPA10465/001/001 VPA10465/001/001 Glucose B. Braun Vet Care 50 mg/ml solution for infusion for cattle, horses, sheep, goats, pigs, dogs and cats B. Braun Melsungen AG. 27/04/2012 VM Unknown AU Solution for infusion QB05BA03 Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Glucose monohydrate Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Sheep Miscellaneous VPA22033/023/001 VPA22033/023/001 Gold Fleece Sheep Dip 600 mg/g Concentrate for Dip Solution Bimeda Animal Health Limited 01/10/1989 VM Unknown AU Concentrate for dip solution QP53AF03 Complete application (stand-alone) - Council Directive 81/851/EEC Cutaneous use Dimpylate Prescription Only Medicine Sheep Ectoparasiticide VPA10539/004/001 VPA10539/004/001 Gonavet Veyx 50 micrograms/ml solution for injection for cattle, pigs and horses Veyx-Pharma GmbH 20/03/2015 VM Unknown AU Solution for injection QH01CA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Gonadorelin (6-D-phenylalanine) acetate Prescription Only Medicine Cattle Horses Pigs Hormone VPA10846/021/001 VPA10846/021/001 GRIPORK emulsion for injection for pigs Laboratorios Hipra S.A. 14/11/2025 VM Unknown AU Emulsion for injection QI09AA03 Full application - known active substance (Article 8 of Regulation (EU) 2019/6) Intramuscular use Influenza A virus, subtype H1N1, strain OLL (swine), Inactivated Influenza A virus, subtype H3N2, strain G (swine), Inactivated Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA10786/007/001 VPA10786/007/001 Halofusol 0.5 mg/ml oral solution for calves Laboratorios Karizoo S.A. 18/12/2020 VM Unknown AU Oral solution QP51AX08 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Halofuginone Prescription Only Medicine Cattle Coccidiostats VPA10454/061/001 VPA10454/061/001 HATCHPAK IB H120 NEO effervescent tablet for nebuliser suspension for chickens Boehringer Ingelheim Vetmedica GmbH 10/02/2017 VM Unknown AU Effervescent tablet QI01AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Nebulisation use Live avian infectious bronchitis virus (strain h120) Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10509/018/002 VPA10509/018/002 Hedylon 25 mg tablets for dogs Industrial Veterinaria S.A. 15/02/2019 VM AU Tablet QH02AB06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Prednisolone Prescription Only Medicine Dogs Corticosteroid VPA10509/018/001 VPA10509/018/001 Hedylon 5 mg tablets for dogs and cats Industrial Veterinaria S.A. 15/02/2019 VM AU Tablet QH02AB06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Prednisolone Prescription Only Medicine Cats Dogs Corticosteroid VPA10389/004/001 VPA10389/004/001 HEMOSILATE 125 mg/ml Solution for injection Ecuphar Veterinaria S.L.U. 30/08/2019 VM Unknown AU Solution for injection QB02BX01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Etamsylate Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Sheep Miscellaneous VPA10996/146/001 VPA10996/146/001 Heptavac P Plus Intervet Ireland Limited 21/03/2003 VM Unknown AU Suspension for injection QI04AB05 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Clostridium perfringens beta toxoid (strains 554 and 578) Clostridium perfringens epsilon toxoid (strain 603) Clostridium septicum toxoid (strain 505) Clostridium tetani toxoid (strain s1123/91) Clostridium novyi toxoid (strain 754) Clostridium chauvoei cells and equivalent toxoid of strain 655 Clostridium chauvoei cells and equivalent toxoid of strain 656 Clostridium chauvoei cells and equivalent toxoid of strain 657 Clostridium chauvoei cells and equivalent toxoid of strain 658 Clostridium chauvoei cells and equivalent toxoid of strain 1048 Formalin pasteurella haemolytica strain a1 (s1006/77) Formalin pasteurella haemolytica strain a2 (s1126/92) Formalin pasteurella haemolytica strain a6 (s1084/81) Formalin pasteurella haemolytica strain a7 (s1078/81) Formalin pasteurella haemolytica strain a9 (s994/77) Formalin pasteurella trehalosi strain t3 (s1109/84) Formalin pasteurella trehalosi strain t4 (s1085/81) Formalin pasteurella trehalosi strain t10 (s1075/81) Formalin pasteurella trehalosi strain t15 (s1105/84) Licensed Retailer Sheep Immunological - Inactivated Vaccine VPA22664/049/001 VPA22664/049/001 Hexasol LA Solution for Injection Norbrook Laboratories (Ireland) Limited 05/02/1999 VM Unknown AU Solution for injection QJ01AA56 Fixed combination application (Article 13b of Directive No 2001/82/EC) Intramuscular use Oxytetracycline dihydrate Flunixin meglumine Prescription Only Medicine Cattle Antibacterial VPA10790/009/001 VPA10790/009/001 HIDROCOL, 4000000 IU/ml solution for use in drinking water/milk SP Veterinaria, S.A. 15/07/2016 VM Unknown AU Solution for use in drinking water/milk QA07AA10 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Colistin Prescription Only Medicine Cattle Chickens Pigs Sheep Turkeys Antibacterial VPA10846/005/001 VPA10846/005/001 HIPRABOVIS SOMNI/Lkt emulsion for injection for cattle Laboratorios Hipra S.A. 27/10/2005 VM Marketed AU Emulsion for injection QI02AB Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Haemophilus somnus bailie strain, inactivated Mannheimia haemolytica, Serotype A1, Strain 2806, Leucotoxoid Prescription Only Medicine Cattle Immunological - Inactivated Vaccine VPA10846/003/001 VPA10846/003/001 HIPRABOVIS-4 Laboratorios Hipra S.A. 06/06/2003 VM Not marketed AU Powder and solvent for suspension for injection QI02AH Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated infectious bovine rhinotracheitis virus strain LA Inactivated parainfluenza-3 virus, strain SF4 Inactivated bovine diarrhoea virus strain NADL Live bovine respiratory strain lym-56 Prescription Only Medicine Cattle Immunological - Mixed Vaccine (L & A) VPA10846/009/001 VPA10846/009/001 Hipracox Broilers Oral suspension for chicken Laboratorios Hipra S.A. 31/10/2007 VM Marketed AU Oral suspension QI01AN01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Eimeria acervulina, strain 003 Eimeria maxima, strain 013 Eimeria mitis, strain 006 Eimeria praecox, strain 007 Eimeria tenella, strain 004 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10846/017/001 VPA10846/017/001 Hipragumboro CW Lyophilisate for use in drinking water Laboratorios Hipra S.A. 07/12/2018 VM AU Lyophilisate for use in drinking water QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) In drinking water use Avian infectious bursal disease virus, live Prescription Only Medicine Chickens Immunological VPA10846/014/001 VPA10846/014/001 HIPRAGUMBORO-G97 Laboratorios Hipra S.A. 29/05/2015 VM Marketed AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Live Infectious Bursal Disease Virus, strain GM97 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10475/029/001 VPA10475/029/001 Histodine 10 mg/ml solution for injection for cattle Le Vet Beheer B.V. 20/10/2017 VM Unknown AU Solution for injection QR06AB04 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Chlorphenamine maleate Prescription Only Medicine Cattle Miscellaneous VPA10782/039/001 VPA10782/039/001 Huvacillin 800 mg/g Powder for use in drinking water for chickens and pigs Huvepharma NV 05/08/2022 VM Unknown AU Powder for use in drinking water QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Drinking Water Amoxicillin trihydrate Prescription Only Medicine Chickens Pigs Antibacterial VPA10782/038/001 VPA10782/038/001 Huvamox 800 mg/g powder for use in drinking water for chickens, turkeys, ducks and pigs Huvepharma NV 16/04/2021 VM Unknown AU Powder for use in drinking water QJ01CA04 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Amoxicillin trihydrate Prescription Only Medicine Chickens Duck Pigs Turkeys Antibacterial VPA10782/037/001 VPA10782/037/001 Huvebiotic 330 mg/100 mg Intramammary solution Huvepharma NV 29/10/2021 VM Unknown AU Intramammary solution QJ51RF03 QJ51RG01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Neomycin sulfate Lincomycin hydrochloride Prescription Only Medicine Cattle Antibacterial VPA10782/027/001 VPA10782/027/001 HuveGuard MMAT suspension for oral suspension for chickens Huvepharma NV 02/09/2016 VM Unknown AU Oral suspension QI01AN Full application (Article 12(3) of Directive No 2001/82/EC) Ocular use Oral use Eimeria acervulina Eimeria maxima Eimeria mitis Eimeria tenella Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10782/025/001 VPA10782/025/001 HuveGuard NB suspension for oral suspension for chickens Huvepharma NV 19/08/2016 VM Unknown AU Oral suspension QI01AN01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Eimeria brunetti strain roybru 3+28 Eimeria necatrix strain mednec 3+8 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10782/040/002 VPA10782/040/002 Huvexxin 100 mg/ml solution for injection for cattle, pigs and sheep Huvepharma NV 03/02/2023 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Tulathromycin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10782/040/001 VPA10782/040/001 Huvexxin 25 mg/ml solution for injection for pigs Huvepharma NV 03/02/2023 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Tulathromycin Prescription Only Medicine Pigs Antibacterial VPA22622/010/001 VPA22622/010/001 HY-50 Vet. 17 mg/ml solution for injection for horses Dechra Regulatory B.V. 22/01/2016 VM Unknown AU Solution for injection QM09AX01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intraarticular use Intravenous use Sodium hyaluronate Prescription Only Medicine Horses Miscellaneous VPA10782/007/001 VPA10782/007/001 HydroDoxx 500 mg/g Powder for use in drinking water for chickens and pigs Huvepharma NV 15/05/2009 VM Unknown AU Powder for oral solution QJ01AA02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Doxycycline Prescription Only Medicine Chickens Pigs Antibacterial VPA10782/043/001 VPA10782/043/001 Hydrotrim 500 mg/g + 100 mg/g powder for use in drinking water/milk for cattle, sheep, pigs and chickens Huvepharma NV 14/08/2023 VM Unknown AU Powder for use in drinking water/milk QJ01EW10 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Sulfadiazine sodium Trimethoprim Prescription Only Medicine Cattle Chickens Pigs Sheep Antibacterial VPA10509/001/001 VPA10509/001/001 Hymatil 300 mg/ml solution for injection for cattle and sheep Industrial Veterinaria S.A. 17/12/2010 VM Marketed AU Solution for injection QJ01FA91 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Tilmicosin Prescription Only Medicine Cattle Sheep Antibacterial VPA10815/026/001 VPA10815/026/001 Hyogen emulsion for injection for pigs Ceva Santé Animale 12/06/2015 VM Unknown AU Emulsion for injection QI09AB13 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated bacterin of mycoplasma hyopneumoniae strain 2940 Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA10454/062/001 VPA10454/062/001 Hyonate 10 mg/ml solution for injection Boehringer Ingelheim Vetmedica GmbH 10/07/2015 VM Marketed AU Solution for injection QM09AX01 Complete application (stand-alone) - Council Directive 81/851/EEC Intraarticular use Intravenous use Sodium hyaluronate Prescription Only Medicine Horses Miscellaneous VPA22622/011/001 VPA22622/011/001 HyperCard 10 mg Coated Tablets for Cats Dechra Regulatory B.V. 10/11/2008 VM Unknown AU Coated tablet QC08DB01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Diltiazem hydrochloride Prescription Only Medicine Cats Cardiovascular VPA10453/001/001 VPA10453/001/001 Hypersol 500 mg/g Powder for use in Drinking water HUVEPHARMA SA 31/05/2013 VM Unknown AU Oral powder QJ01AA06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Oxytetracycline Prescription Only Medicine Chickens Pigs Antibacterial VPA10539/003/001 VPA10539/003/001 Hypophysin LA 35 microgram/ml solution for injection for cattle and pigs Veyx-Pharma GmbH 22/08/2014 VM Marketed AU Solution for injection QH01BB03 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Carbetocin Prescription Only Medicine Cattle Pigs Hormone VPA10539/003/002 VPA10539/003/002 Hypophysin LA 70 microgram/ml solution for injection for cattle and pigs Veyx-Pharma GmbH 22/08/2014 VM Marketed AU Solution for injection QH01BB03 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Carbetocin Prescription Only Medicine Cattle Pigs Hormone VPA10481/001/001 VPA10481/001/001 Imaverol 100 mg/ml Concentrate for Cutaneous Emulsion Audevard 30/09/2009 VM Unknown AU Cutaneous emulsion QD01AC90 Full application (Article 12(3) of Directive No 2001/82/EC) Cutaneous use Enilconazole Prescription Only Medicine Cattle Dogs Horses Antifungal VPA22693/007/001 VPA22693/007/001 Imec 10 mg/ml Solution for Injection ECO Animal Health Europe Limited 26/11/2004 VM Marketed AU Solution for injection QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA20742/009/001 VPA20742/009/001 Imidokal 85 mg/ml solution for injection for cattle and dogs Vet-Agro Multi-Trade Company Sp z o.o. 29/09/2023 VM Unknown AU Solution for injection QP51E Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Subcutaneous use Imidocarb dipropionate Prescription Only Medicine Cattle Dogs Endoparasiticide VPA10996/234/001 VPA10996/234/001 Imizol 85 mg/ml Solution for Injection Intervet Ireland Limited 01/10/1999 VM Unknown AU Solution for injection QP51EX01 Complete application (stand-alone) - Council Directive 81/851/EEC Subcutaneous use Imidocarb dipropionate Prescription Only Medicine Cattle Endoparasiticide VPA10774/067/002 VPA10774/067/002 Imoxicate 100 mg/25 mg spot-on solution for medium dogs Krka, d.d., Novo mesto 13/03/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/067/003 VPA10774/067/003 Imoxicate 250 mg/62.5 mg spot-on solution for large dogs Krka, d.d., Novo mesto 13/03/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/067/001 VPA10774/067/001 Imoxicate 40 mg/10 mg spot-on solution for small dogs Krka, d.d., Novo mesto 13/03/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/065/001 VPA10774/065/001 Imoxicate 40 mg/4 mg spot-on solution for small cats and ferrets Krka, d.d., Novo mesto 13/03/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Cats Ferrets Endectoparasiticides VPA10774/067/004 VPA10774/067/004 Imoxicate 400 mg/100 mg spot-on solution for extra-large dogs Krka, d.d., Novo mesto 13/03/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/066/001 VPA10774/066/001 Imoxicate 80 mg/8 mg spot-on solution for large cats Krka, d.d., Novo mesto 13/03/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Cats Endectoparasiticides VPA10516/010/001 VPA10516/010/001 INDUPART 75 micrograms /mL solution for injection for cattle, pigs and horses Vetpharma Animal Health S.L. 15/08/2014 VM Marketed AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use D-cloprostenol sodium salt Prescription Only Medicine Cattle Horses Pigs Hormone VPA10495/012/001 VPA10495/012/001 Ingelvac Ery emulsion for injection for pigs Laboratorios Syva S.A. 18/02/2022 VM Unknown AU Emulsion for injection QI09AB03 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Erysipelothrix rhusiopathiae, serotype 2, Inactivated Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA10454/007/001 VPA10454/007/001 Ingelvac MycoFLEX suspension for injection for pigs Boehringer Ingelheim Vetmedica GmbH 24/07/2009 VM Unknown AU Suspension for injection QI09AB13 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated mycoplasma hyopneumoniae, j strain isolate b-3745 Licensed Retailer Pigs Immunological - Inactivated Vaccine VPA10454/008/001 VPA10454/008/001 Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for injection for pigs Boehringer Ingelheim Vetmedica GmbH 02/04/2015 VM Unknown AU Lyophilisate and solvent for suspension for injection QI09AD03 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Attenuated prrs 94881 virus Prescription Only Medicine Pigs Immunological - Live Vaccine VPA20742/011/001 VPA20742/011/001 Iniram 10 mg/ml solution for injection for dogs and cats Vet-Agro Multi-Trade Company Sp z o.o. 23/01/2026 VM Unknown AU Solution for injection QA04AD90 Generic application (Article 18 of Regulation (EU) 2019/6) Intravenous use Subcutaneous use Maropitant Prescription Only Medicine Cats Dogs Miscellaneous VPA10846/018/001 VPA10846/018/001 INMEVA, suspension for injection for sheep Laboratorios Hipra S.A. 14/06/2019 VM Marketed AU Suspension for injection QI04AB Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Chlamydophila abortus strain A22 inactivated Salmonella enterica subsp. enterica serovar Abortusovis strain Sao Prescription Only Medicine Sheep Immunological - Inactivated Vaccine VPA22664/119/001 VPA22664/119/001 Insecinor 10 mg/ml Spot-on Solution for cattle and sheep Norbrook Laboratories (Ireland) Limited 05/09/2014 VM Unknown AU Spot-on solution QP53AC11 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Deltamethrin Prescription Only Medicine Cattle Sheep Ectoparasiticide VPA23462/009/001 VPA23462/009/001 Insistor 10 mg/ml solution for injection for dogs and cats VetViva Richter GmbH 20/07/2018 VM Unknown AU Solution for injection QN02AC90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Methadone hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA23184/001/001 VPA23184/001/001 Intercam 0.5 mg/ml oral suspension for cats C&H Generics Limited 15/07/2022 VM Unknown AU Oral suspension QM01AC06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Meloxicam Prescription Only Medicine Cats N.S.A.I.D. VPA23184/002/001 VPA23184/002/001 Intercam 1.5 mg/ml Oral Suspension for Dogs C&H Generics Limited 13/03/2026 VM Unknown AU Oral suspension QM01AC06 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Meloxicam Prescription Only Medicine Dogs N.S.A.I.D. VPA23184/003/001 VPA23184/003/001 Intercam 20 mg/ml solution for injection for cattle, pigs and horses C&H Generics Limited 06/03/2026 VM Unknown AU Solution for injection QM01AC06 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Subcutaneous use Meloxicam Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10823/011/001 VPA10823/011/001 Interclox DC Intramammary Suspension Chem-Pharm Limited 01/10/1999 VM AU Intramammary suspension QJ51RC Informed consent application (Article 13c of Directive No 2001/82/EC) Intramammary use Cloxacillin Benzathine Ampicillin trihydrate Prescription Only Medicine Cattle Antibacterial VPA10555/006/001 VPA10555/006/001 Interject 15% solution for injection for cattle, sheep and pigs Interchem Ireland Ltd 21/03/2008 VM Unknown AU Solution for injection QJ01AA06 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Oxytetracycline hydrochloride Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10823/005/001 VPA10823/005/001 Intertrim Solution for Injection Chem-Pharm Limited 01/10/1998 VM AU Solution for injection QJ01EW10 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Trimethoprim Sulfadiazine Prescription Only Medicine Cats Cattle Dogs Horses Pigs Antibacterial VPA10987/185/001 VPA10987/185/001 Interzuril 50 mg/ml oral suspension for Piglets, Calves and Lambs Chanelle Pharmaceuticals Manufacturing Limited 31/10/2025 VM Unknown AU Oral suspension QP51AJ01 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Toltrazuril Prescription Only Medicine Cattle Pigs Sheep Coccidiostats VPA10409/001/001 VPA10409/001/001 INTRA DYSOVINOL 499 mg/ml solution for use in drinking water for pigs Intracare B.V. 06/09/2019 VM Unknown AU Solution for use in drinking water QA07XA Full application (Article 12(3) of Directive No 2001/82/EC) In drinking water use Disodium zinc edetate Prescription Only Medicine Pigs Miscellaneous VPA22622/013/001 VPA22622/013/001 Intra-Epicaine 20 mg/ml solution for injection for horses Dechra Regulatory B.V. 01/12/2006 VM Unknown AU Solution for injection QN01BB03 Well-established use application (Article 13a of Directive No 2001/82/EC) Epidural use Intraarticular use Intrabursal use Perineural use Mepivacaine hydrochloride Prescription Only Medicine Horses Horse (non-food producing) Neurological Preparations VPA22812/005/001 VPA22812/005/001 Introflor Vet 300 mg/ml solution for injection for cattle, sheep and pigs Interchemie Werken De Adelaar Eesti AS. 05/12/2025 VM Unknown AU Solution for injection QJ01BA90 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Subcutaneous use Florfenicol Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22622/014/001 VPA22622/014/001 Intubeaze 20 mg/ml laryngopharyngeal spray, solution for cats Dechra Regulatory B.V. 07/12/2018 VM AU Laryngopharyngeal spray, solution QR02AD02 Generic application (Article 13(1) of Directive No 2001/82/EC) Laryngopharyngeal use Lidocaine Hydrochloride Monohydrate Prescription Only Medicine Cats Neurological Preparations VPA10803/006/001 VPA10803/006/001 Isaderm 5 mg/g + 1 mg/g gel for dogs Dechra Veterinary Products A/S 14/03/2014 VM Unknown AU Gel QD07CC01 Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Fusidic acid Betamethasone valerate Prescription Only Medicine Dogs Antibacterial VPA10803/004/001 VPA10803/004/001 Isathal 10 mg/g eye drops, suspension for dogs, cats and rabbits Dechra Veterinary Products A/S 15/11/2001 VM Marketed AU Eye drops, suspension QS01AA13 Complete application (stand-alone) - Council Directive 81/851/EEC Ocular use Fusidic acid Prescription Only Medicine Cats Dogs Rabbits Antibacterial VPA22583/001/001 VPA22583/001/001 Iso-Vet 1000 mg/g Inhalation Vapour, liquid Piramal Critical Care B.V. 25/11/2011 VM Unknown AU Inhalation vapour, liquid QN01AB06 Generic application (Article 13(1) of Directive No 2001/82/EC) Inhalation use Isoflurane Prescription Only Medicine Cats Chinchilla Dogs Ferrets Gerbil Guinea pig Hamster Horses Mouse Ornamental birds Pigs Rat Reptiles Neurological Preparations VPA10516/012/001 VPA10516/012/001 ISOFLURIN 1000 mg/g Inhalation Vapour, Liquid Vetpharma Animal Health S.L. 15/01/2016 VM Marketed AU Inhalation vapour, liquid QN01AB06 Generic application (Article 13(1) of Directive No 2001/82/EC) Inhalation use Isoflurane Prescription Only Medicine Cats Chinchilla Dogs Ferrets Gerbil Guinea pig Hamster Horses Mouse Ornamental birds Rat Reptiles Neurological Preparations VPA22583/002/001 VPA22583/002/001 Isothesia 1000 mg/g inhalation vapour, liquid Piramal Critical Care B.V. 09/04/2020 VM Unknown AU Inhalation vapour, liquid QN01AB06 Generic application (Article 13(1) of Directive No 2001/82/EC) Inhalation use Isoflurane Prescription Only Medicine Cats Chinchilla Dogs Ferrets Gerbil Guinea pig Hamster Horses Mouse Ornamental birds Rat Reptiles Neurological Preparations VPA10988/116/001 VPA10988/116/001 Itrafungol 10 mg/ml Oral Solution Virbac 20/07/2012 VM Unknown AU Oral solution QJ02AC02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Itraconazole Prescription Only Medicine Cats Antifungal VPA22664/148/001 VPA22664/148/001 Iverpraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses Norbrook Laboratories (Ireland) Limited 27/09/2013 VM Unknown AU Oral paste QP54AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Ivermectin Praziquantel Prescription Only Medicine Horses Endectoparasiticides VPA10454/064/001 VPA10454/064/001 Ivomec Classic Injection for Cattle and Sheep 10 mg/ml Boehringer Ingelheim Vetmedica GmbH 01/10/1994 VM Unknown AU Solution for injection QP54AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Sheep Endectoparasiticides VPA10454/065/001 VPA10454/065/001 Ivomec Classic Pour-On for Cattle 5 mg/ml Boehringer Ingelheim Vetmedica GmbH 30/03/2000 VM Unknown AU Pour-on solution QP54AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10454/068/001 VPA10454/068/001 Ivomec Super Injection for Cattle Boehringer Ingelheim Vetmedica GmbH 01/10/1999 VM Unknown AU Solution for injection QP54AA51 Fixed combination application (Article 13b of Directive No 2001/82/EC) Subcutaneous use Ivermectin Clorsulon Prescription Only Medicine Cattle Endectoparasiticides VPA20742/007/001 VPA20742/007/001 Kabergovet 50 microgram/ml oral solution for dogs and cats Vet-Agro Multi-Trade Company Sp z o.o. 05/02/2021 VM Unknown AU Oral solution QG02CB03 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cabergoline Prescription Only Medicine Cats Dogs Hormone HOVR10537/011/001 HOVR10537/011/001 Kali Sulphuricum 200c Galway Homeopathics (Manufacturing) Limited 18/10/2013 VM Unknown AU Oral solution Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC) Oral use Kali sulphuricum Licensed Retailer Cattle Goats Horses Sheep Homeopathic VPA10555/001/001 VPA10555/001/001 Kanacef M.C. Intramammary Suspension Interchem (Ireland) Limited 18/04/2008 VM Unknown AU Intramammary suspension QJ51RD01 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramammary use Cefalexin Kanamycin Prescription Only Medicine Cattle Antibacterial VPA10786/002/001 VPA10786/002/001 KARIFLOX 100 mg/ml Oral Solution for Chickens and Turkeys Laboratorios Karizoo S.A. 12/09/2008 VM Unknown AU Oral solution QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Chickens Turkeys Antibacterial VPA10786/004/001 VPA10786/004/001 KARIFLOX 25 mg/ml oral solution for calves Laboratorios Karizoo S.A. 10/07/2009 VM Unknown AU Oral solution QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Cattle Antibacterial VPA10786/003/001 VPA10786/003/001 KARIFLOX 5 mg/ml oral solution for piglets Laboratorios Karizoo S.A. 10/07/2009 VM Unknown AU Oral solution QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Pigs Antibacterial VPA10774/006/003 VPA10774/006/003 Karprovet 100 mg tablets for dogs Krka, d.d., Novo mesto 10/12/2010 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/006/001 VPA10774/006/001 Karprovet 20 mg tablets for dogs Krka, d.d., Novo mesto 10/12/2010 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/005/001 VPA10774/005/001 Karprovet 50 mg/ml solution for injection for dogs and cats Krka, d.d., Novo mesto 10/12/2010 VM Not marketed AU Solution for injection QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/006/002 VPA10774/006/002 Karprovet 50 mg tablets for dogs Krka, d.d., Novo mesto 10/12/2010 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA22033/025/001 VPA22033/025/001 Keelogane SC 25 mg/ml Oral suspension for Cattle and Sheep Bimeda Animal Health Limited 30/06/2003 VM Unknown AU Oral suspension QP52AC11 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Albendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA22033/041/001 VPA22033/041/001 KEFAMAST Dry Cow Intramammary Suspension Bimeda Animal Health Limited 01/10/1988 VM Unknown AU Intramammary suspension QJ51RD01 Informed consent (abridged application) - Council Directive 81/851/EEC Intramammary use Cefalexin Dihydrostreptomycin sulfate Prescription Only Medicine Cattle Antibacterial VPA10981/016/001 VPA10981/016/001 Kelamoxil LA 150 mg/ml suspension for injection for cattle and pigs Kela n.v. 25/08/2023 VM Unknown AU Suspension for injection QJ01CA04 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Amoxicillin trihydrate Prescription Only Medicine Cattle Pigs Antibacterial VPA10981/012/001 VPA10981/012/001 Kelaprofen 100 mg/ml, solution for injection for cattle, horses and pigs Kela n.v. 24/02/2012 VM AU Solution for injection QM01AE03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10509/026/001 VPA10509/026/001 Kelevo 200 µg tablets for dogs and cats Industrial Veterinaria S.A. 11/06/2021 VM Unknown AU Tablet QH03AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA10509/026/002 VPA10509/026/002 Kelevo 400 µg tablets for dogs and cats Industrial Veterinaria S.A. 11/06/2021 VM Unknown AU Tablet QH03AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA10509/026/003 VPA10509/026/003 Kelevo 800 µg tablets for dogs Industrial Veterinaria S.A. 11/06/2021 VM Unknown AU Tablet QH03AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10792/003/001 VPA10792/003/001 Kenocidin Chlorhexidine digluconate 5 mg/ml, Teat dip solution for cattle (dairy) CID LINES N.V. 21/04/2011 VM Unknown AU Oral solution QD08AC02 Full application (Article 12(3) of Directive No 2001/82/EC) Teat use Chlorhexidine digluconate Licensed Retailer Cattle Antiseptics VPA10792/004/001 VPA10792/004/001 Kenocidin SPRAY AND DIPChlorhexidine digluconate 5 mg/ml, Teat Dip/Teat Spray solution for cattle (dairy) CID LINES N.V. 15/07/2011 VM Unknown AU Teat dip/spray solution QD08AC02 Full application (Article 12(3) of Directive No 2001/82/EC) Teat use Chlorhexidine digluconate Licensed Retailer Cattle Antiseptics VPA10792/001/001 VPA10792/001/001 Kenostart 3 mg/g teat dip solution for cattle (dairy). CID LINES N.V. 19/01/2006 VM Unknown AU Teat dip solution QD08AG03 Full application (Article 12(3) of Directive No 2001/82/EC) Teat use Iodine Licensed Retailer Cattle Antiseptics VPA10792/002/001 VPA10792/002/001 KENOSTART SPRAY AND DIP 3 mg/g Teat Dip or Spray Solution for cattle (dairy) CID LINES N.V. 14/03/2008 VM Unknown AU Teat dip solution QD08AG03 Full application (Article 12(3) of Directive No 2001/82/EC) Topical use Teat use Iodine Licensed Retailer Cattle Antiseptics VPA10815/034/003 VPA10815/034/003 Kesium 200 mg/50 mg Chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Dogs Antibacterial VPA10815/034/001 VPA10815/034/001 Kesium 40 mg/10 mg Chewable tablets for cats and dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Cats Dogs Antibacterial VPA10815/034/004 VPA10815/034/004 Kesium 400 mg/100 mg Chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Dogs Antibacterial VPA10815/034/002 VPA10815/034/002 Kesium 50 mg/12.5 mg Chewable tablets for cats and dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Cats Dogs Antibacterial VPA10815/034/005 VPA10815/034/005 Kesium 500 mg/125 mg Chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin Clavulanic acid Prescription Only Medicine Dogs Antibacterial VPA10445/005/001 VPA10445/005/001 Ketabel 100 mg/ml solution for injection Bela-Pharm GmbH & Co. KG 03/07/2020 VM AU Solution for injection QN01AX03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intraperitoneal use Intravenous use Ketamine hydrochloride Prescription Only Medicine Cats Cattle Dogs Goats Guinea pig Hamster Horses Mouse Pigs Rabbits Rat Sheep Neurological Preparations VPA23462/004/001 VPA23462/004/001 Ketamidor 100 mg/ml solution for injection VetViva Richter GmbH 08/02/2013 VM Unknown AU Solution for injection QN01AX03 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Ketamine hydrochloride Prescription Only Medicine Cats Cattle Dogs Horses Pigs Neurological Preparations VPA10387/036/001 VPA10387/036/001 Ketavet 100 mg/ml solution for injection for dogs, cats and horses Zoetis Belgium S.A. 20/03/2015 VM Unknown AU Solution for injection QN01AX03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Ketamine Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA10980/016/001 VPA10980/016/001 Ketexx 100 mg/ml solution for injection Alfasan Nederland B.V. 20/05/2022 VM Unknown AU Solution for injection QN01AX03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intraperitoneal use Intravenous use Ketamine hydrochloride Prescription Only Medicine Cats Cattle Dogs Goats Guinea pig Hamster Horses Mouse Rabbits Rat Sheep Neurological Preparations VPA10509/002/001 VPA10509/002/001 Ketink 100 mg/ml solution for injection for cattle, pigs and horses Industrial Veterinaria S.A. 10/02/2012 VM Marketed AU Solution for injection QM01AE03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA23462/019/001 VPA23462/019/001 Ketiva 150 mg/ml solution for injection for cattle, pigs and horses VetViva Richter GmbH 27/02/2026 VM Unknown AU Solution for injection QM01AE03 Hybrid application – change in therapeutic indication(s) (Article 19(1)(a) of Regulation (EU) 2019/6) Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10475/008/001 VPA10475/008/001 Ketodolor 100 mg/ml solution for injection for horses, cattle, pigs Le Vet Beheer B.V. 17/05/2013 VM Unknown AU Solution for injection QM01AE03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10815/051/001 VPA10815/051/001 Ketofen 100 mg/ml Solution for Injection Ceva Santé Animale 15/03/1996 VM Unknown AU Solution for injection QM01AE03 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses N.S.A.I.D. VPA23448/002/001 VPA23448/002/001 Ketoprocen 150 mg/ml solution for injection for cattle, pigs and horses Cenavisa S.L 10/10/2025 VM Unknown AU Solution for injection QM01AE03 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA22812/004/001 VPA22812/004/001 Ketosol 100 mg/ml solution for injection for cattle, pigs and horses Interchemie Werken De Adelaar Eesti AS. 29/04/2022 VM Unknown AU Solution for injection QM01AE03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA22693/020/001 VPA22693/020/001 Kilo-mec 1% Solution for Injection ECO Animal Health Europe Limited 14/06/2000 VM Unknown AU Solution for injection QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA23349/002/003 VPA23349/002/003 KUIVET 134 mg/1200 mg spot-on solution for medium dogs Quimica De Munguia S.A. (Quimunsa) 14/08/2026 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 19(1) of Regulation (EU) 2019/6) Spot-on use Fipronil Permethrin (40:60) Prescription Only Medicine Dogs Ectoparasiticide VPA23349/002/001 VPA23349/002/001 KUIVET 26.8 mg/240 mg spot-on solution for very small dogs Quimica De Munguia S.A. (Quimunsa) 14/08/2026 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 19(1) of Regulation (EU) 2019/6) Spot-on use Fipronil Permethrin (40:60) Prescription Only Medicine Dogs Ectoparasiticide VPA23349/002/004 VPA23349/002/004 KUIVET 268 mg/2400 mg spot-on solution for large dogs Quimica De Munguia S.A. (Quimunsa) 14/08/2026 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 19(1) of Regulation (EU) 2019/6) Spot-on use Fipronil Permethrin (40:60) Prescription Only Medicine Dogs Ectoparasiticide VPA23349/002/002 VPA23349/002/002 KUIVET 67 mg/600 mg spot-on solution for small dogs Quimica De Munguia S.A. (Quimunsa) 14/08/2026 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 19(1) of Regulation (EU) 2019/6) Spot-on use Fipronil Permethrin (40:60) Prescription Only Medicine Dogs Ectoparasiticide VPA10402/008/001 VPA10402/008/001 Labimycin LA 300 mg/ml solution for injection Labiana Life Sciences, S.A. 23/08/2024 VM Unknown AU Solution for injection QJ01AA06 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Oxytetracycline dihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10402/005/001 VPA10402/005/001 Labiprofen 150 mg/ml solution for injection for cattle, pigs and horses Labiana Life Sciences, S.A. 12/11/2021 VM Unknown AU Solution for injection QM01AE03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA22664/042/001 VPA22664/042/001 Lactatrim MC Lactating Cow Intramammary Suspension. Norbrook Laboratories (Ireland) Limited 18/10/1996 VM Unknown AU Intramammary suspension QJ51E Fixed combination application (Article 13b of Directive No 2001/82/EC) Intramammary use Trimethoprim Sulphadiazine Prescription Only Medicine Cattle Antibacterial VPA10980/032/001 VPA10980/032/001 Lamoxsan 150 mg/ml suspension for injection for cattle and pigs Alfasan Nederland B.V. 21/07/2023 VM Unknown AU Suspension for injection QJ01CA04 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Amoxicillin trihydrate Prescription Only Medicine Cattle Pigs Antibacterial VPA22009/002/001 VPA22009/002/001 Latroxin 100 mg/ml solution for injection for cattle, pigs and sheep MEVET S.A.U. 30/05/2025 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Subcutaneous use Tulathromycin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10996/002/001 VPA10996/002/001 Laurabolin 25 mg/ml solution for injection Intervet Ireland Limited 01/10/1987 VM Unknown AU Solution for injection QA14AB01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Nandrolone laurate Prescription Only Medicine Cats Dogs Hormone VPA10980/048/001 VPA10980/048/001 Laxasan 667 mg/ml syrup for dogs and cats Alfasan Nederland B.V. 31/07/2026 VM Unknown AU Syrup QA06AD11 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Lactulose, liquid Prescription Only Medicine Cats Dogs Alimentary Tract Preparation VPA10475/041/001 VPA10475/041/001 Laxatract 667mg/ml syrup for dogs and cats Le Vet Beheer B.V. 11/01/2019 VM AU Syrup QA06AD11 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Lactulose, liquid Prescription Only Medicine Cats Dogs Alimentary Tract Preparation VPA22020/030/001 VPA22020/030/001 LECTADE Plus Powder for Oral Solution Elanco GmbH 21/03/2011 VM Unknown AU Powder for oral solution QA07CQ02 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Sodium chloride Glycine Potassium dihydrogen phosphate Sodium acid citrate Potassium citrate Sodium citrate Glucose monohydrate Licensed Retailer Cattle Electrolytes VPA10454/082/001 VPA10454/082/001 Lenzelta suspension for injection Boehringer Ingelheim Vetmedica GmbH 05/12/2025 VM Unknown AU Suspension for injection QI02AB17 Full application (Article 8 of Regulation (EU) 2019/6) Intramuscular use Escherichia Coli (Inactivated) Staphylococcus aureus inactivated bacteria Prescription Only Medicine Cattle Immunological - Inactivated Vaccine VPA22664/025/001 VPA22664/025/001 Levacide Injection 75 mg/ml Norbrook Laboratories (Ireland) Limited 01/10/1989 VM Unknown AU Solution for injection QP52AE01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Levamisole hydrochloride Prescription Only Medicine Cattle Sheep Endoparasiticide VPA22664/026/001 VPA22664/026/001 Levacide Low Volume Worm Drench 75 mg/ml Norbrook Laboratories (Ireland) Limited 01/10/1989 VM Unknown AU Oral solution QP52AE01 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Levamisole hydrochloride Prescription Only Medicine Cattle Sheep Endoparasiticide VPA22664/047/001 VPA22664/047/001 Levacide Pour-on 200 mg/ml Norbrook Laboratories (Ireland) Limited 12/12/1997 VM Unknown AU Pour-on solution QP52AE01 Informed consent (abridged application) - Council Directive 81/851/EEC Pour-on use Topical use Levamisole hydrochloride Prescription Only Medicine Cattle Endoparasiticide VPA22664/024/001 VPA22664/024/001 Levafas Diamond Fluke and Worm Drench Norbrook Laboratories (Ireland) Limited 01/10/1989 VM Unknown AU Oral suspension QP52AE51 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Levamisole hydrochloride Oxyclozanide Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10823/010/001 VPA10823/010/001 Levapharm Injection 75 mg/ml Chem-Pharm Limited 01/10/1999 VM AU Solution for injection QP52AE01 Informed consent application (Article 13c of Directive No 2001/82/EC) Subcutaneous use Levamisole hydrochloride Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10996/199/001 VPA10996/199/001 Leventa 1 mg/ml oral solution for dogs Intervet Ireland Limited 29/06/2007 VM Marketed AU Oral solution QH03AA01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10915/004/001 VPA10915/004/001 Levicare Hi-Mineral Oral Solution Ancare Ireland Ltd. 31/03/1999 VM AU Oral solution QP52AE01 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Levamisole hydrochloride Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10815/037/001 VPA10815/037/001 Libeo 10 mg chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QC03CA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Furosemide Prescription Only Medicine Dogs Cardiovascular VPA10815/037/002 VPA10815/037/002 Libeo 40 mg chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QC03CA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Furosemide Prescription Only Medicine Dogs Cardiovascular VPA22622/015/001 VPA22622/015/001 Libromide 325 mg tablets for dogs Dechra Regulatory B.V. 18/11/2011 VM Unknown AU Tablet QN05CM11 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Potassium bromide Prescription Only Medicine Dogs Neurological Preparations VPA22033/026/001 VPA22033/026/001 Liceban 2.5% w/v Pour on Solution Bimeda Animal Health Limited 12/12/2003 VM Unknown AU Pour-on solution QP53AC08 Informed consent application (Article 13c of Directive No 2001/82/EC) Pour-on use Cypermethrin technical (93%) (cis: trans 50:50) Prescription Only Medicine Cattle Ectoparasiticide VPA10445/004/001 VPA10445/004/001 LidoBel 20 mg/ml solution for injection for horses, dogs, and cats. Bela-Pharm GmbH & Co. KG 06/07/2018 VM Unknown AU Solution for injection QN01BB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Perineural use Subcutaneous use Submucosal use Lidocaine hydrochloride Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA25497/004/001 VPA25497/004/001 Linco-Spectin 100, 222/444.7 mg/g Powder for use in drinking water for pigs and chickens Phibro Animal Health (Poland) Sp. z o.o. 01/10/2003 VM Unknown AU Powder for use in drinking water QJ01FF52 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Spectinomycin Lincomycin Prescription Only Medicine Chickens Pigs Antibacterial VPA10387/041/001 VPA10387/041/001 Linco-Spectin Sterile Solution for injection for pigs, non-ruminating calves, dogs and cats Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Solution for injection QJ01FF52 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Lincomycin hydrochloride Spectinomycin sulfate Prescription Only Medicine Cats Cattle Dogs Pigs Antibacterial VPA10387/039/001 VPA10387/039/001 Lincocin 100 mg/ml Sterile Solution for injection for dogs, cats and pigs Zoetis Belgium S.A. 10/10/2014 VM Unknown AU Solution for injection QJ01FF02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Lincomycin hydrochloride Prescription Only Medicine Cats Dogs Pigs Antibacterial VPA25497/003/001 VPA25497/003/001 Lincocin Soluble Powder, 400 mg/g powder for use in drinking water Phibro Animal Health (Poland) Sp. z o.o. 26/09/2014 VM Unknown AU Powder for use in drinking water QJ01FF02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Lincomycin hydrochloride Prescription Only Medicine Chickens Pigs Antibacterial VPA10782/041/001 VPA10782/041/001 Lincoral-S 222 mg/g + 444.7 mg/g powder for use in drinking water Huvepharma NV 08/09/2023 VM Unknown AU Powder for use in drinking water QJ01FF52 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Lincomycin hydrochloride monohydrate Spectinomycin sulfate tetrahydrate Prescription Only Medicine Chickens Pigs Antibacterial VPA10790/015/001 VPA10790/015/001 Lincovex 100 mg/ml solution for injection for pigs, cats and dogs SP Veterinaria, S.A. 23/02/2024 VM Unknown AU Solution for injection QJ01FF02 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Lincomycin hydrochloride monohydrate Prescription Only Medicine Cats Dogs Pigs Antibacterial VPA22664/023/001 VPA22664/023/001 Liquid Life Aid Concentrate for Oral Solution for Cattle, Pigs and Sheep Norbrook Laboratories (Ireland) Limited 01/10/1989 VM Unknown AU Oral solution QA07CQ02 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Glucose monohydrate Sodium chloride Sodium propionate Potassium dihydrogen orthophosphate Glycine Licensed Retailer Cattle Pigs Sheep Electrolytes VPA10436/004/001 VPA10436/004/001 Lismay 444.7 mg/g + 222.0 mg/g powder for use in drinking water for pigs Laboratorios Maymo S.A.U. 06/03/2020 VM Unknown AU Powder for use in drinking water QJ01FF52 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Spectinomycin Lincomycin Prescription Only Medicine Pigs Antibacterial VPA22622/032/001 VPA22622/032/001 Lodisure 1 mg tablets for cats Dechra Regulatory B.V. 05/02/2021 VM Unknown AU Tablet QC08CA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Amlodipine Prescription Only Medicine Cats Cardiovascular VPA10815/023/001 VPA10815/023/001 Longocilline 150 mg/ml suspension for injection for cattle and pigs Ceva Santé Animale 11/01/2013 VM Unknown AU Suspension for injection QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Amoxicillin trihydrate Prescription Only Medicine Cattle Pigs Antibacterial VPA25237/002/001 VPA25237/002/001 Lozenord 5 mg/ml solution for injection for dogs and cats Accord Healthcare B.V. 07/02/2025 VM Unknown AU Solution for injection QM01AC06 Generic application (Article 18 of Regulation (EU) 2019/6) Intravenous use Subcutaneous use Meloxicam Prescription Only Medicine Cats Dogs N.S.A.I.D. VPA10387/042/001 VPA10387/042/001 Lutalyse Zoetis Belgium S.A. 18/10/2013 VM Marketed AU Solution for injection QG02AD01 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Dinoprost trometamol Prescription Only Medicine Cattle Horses Pigs Hormone VPA10387/042/002 VPA10387/042/002 Lutalyse High Concentration 12.5 mg/ml solution for injection for cattle Zoetis Belgium S.A. 23/03/2018 VM Unknown AU Solution for injection QG02AD01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Dinoprost trometamol Prescription Only Medicine Cattle Hormone VPA23174/004/001 VPA23174/004/001 Luteoplan 250 micrograms/ml solution for injection for cattle and horses Syn Vet-Pharma Ireland Limited 13/10/2023 VM Unknown AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cloprostenol sodium Prescription Only Medicine Cattle Horses Hormone VPA25365/001/001 VPA25365/001/001 Lyncoo 400 mg/g powder for use in drinking water for pigs and chickens Endectovet EOOD 19/09/2025 VM Unknown AU Powder for use in drinking water QJ01FF02 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Lincomycin hydrochloride Prescription Only Medicine Chickens Pigs Antibacterial VPA10996/236/001 VPA10996/236/001 M+PAC Intervet Ireland Limited 12/09/2002 VM Unknown AU Emulsion for injection QI09AB13 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated mycoplasma hyopneumoniae Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA22664/075/001 VPA22664/075/001 Macromectin 0.8 mg/ml oral solution for sheep Norbrook Laboratories (Ireland) Limited 02/09/2005 VM Unknown AU Oral solution QP54AA01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA22664/076/001 VPA22664/076/001 Macromectin 5 mg/ml Pour-On Solution Norbrook Laboratories (Ireland) Limited 25/11/2005 VM Unknown AU Pour-on solution QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA22033/073/001 VPA22033/073/001 Macrosyn 100 mg/ml solution for injection for cattle, pigs and sheep Bimeda Animal Health Limited 11/09/2020 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Tulathromycin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10987/037/001 VPA10987/037/001 Magnesium Sulphate 25% Solution for Injection Chanelle Pharmaceuticals Manufacturing Limited 01/10/1991 VM Unknown AU Solution for injection QA12CC02 Complete application (stand-alone) - Council Directive 81/851/EEC Intravenous use Subcutaneous use Magnesium sulphate heptahydrate Licensed Retailer Cattle Vitamins and minerals VPA22664/030/001 VPA22664/030/001 Magniject 250 mg/ml Solution for Injection Norbrook Laboratories (Ireland) Limited 01/10/1991 VM Unknown AU Solution for injection QA12CC02 Complete application (stand-alone) - Council Directive 81/851/EEC Subcutaneous use Magnesium sulphate heptahydrate Licensed Retailer Cattle Sheep Vitamins and minerals VPA10803/005/001 VPA10803/005/001 Malaseb shampoo for dogs and cats Dechra Veterinary Products A/S 16/01/2009 VM Unknown AU Shampoo QD01AC52 Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Chlorhexidine digluconate Miconazole nitrate Prescription Only Medicine Cats Dogs Antifungal VPA10454/009/001 VPA10454/009/001 Mamyzin 269.5 mg/ml Powder and Solvent for Suspension for Injection for cattle Boehringer Ingelheim Vetmedica GmbH 03/03/2000 VM Unknown AU Powder and solvent for suspension for injection QJ01CE90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Penethamate hydriodide Prescription Only Medicine Cattle Antibacterial VPA10539/001/001 VPA10539/001/001 Maprelin 75 microgram/ml solution for injection for pigs Veyx-Pharma GmbH 03/07/2009 VM Unknown AU Solution for injection QH01CA Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Peforelin Prescription Only Medicine Pigs Hormone VPA10990/029/001 VPA10990/029/001 Maracycline 500 mg/g Premix for Medicated Feeding Univet Limited 25/07/1994 VM Not marketed AU Premix for medicated feeding stuff QJ01AA06 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Oxytetracycline hydrochloride Prescription Only Medicine Atlantic salmon Antibacterial VPA10990/031/001 VPA10990/031/001 Maracycline Powder 100 % w/w Premix for Medicated Feed Univet Limited 03/10/1997 VM Unknown AU Premix for medicated feeding stuff QJ01AA06 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Oxytetracycline hydrochloride Prescription Only Medicine Atlantic salmon Antibacterial VPA10534/004/002 VPA10534/004/002 Marbocare flavour 20 mg tablets for dogs Emdoka 20/09/2013 VM Unknown AU Tablet QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Dogs Antibacterial VPA10534/004/001 VPA10534/004/001 Marbocare flavour 5 mg tablets for dogs and cats Emdoka 20/09/2013 VM Unknown AU Tablet QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Cats Dogs Antibacterial VPA10534/004/003 VPA10534/004/003 Marbocare flavour 80 mg tablets for dogs Emdoka 20/09/2013 VM Unknown AU Tablet QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Dogs Antibacterial VPA10521/025/001 VPA10521/025/001 Marbocyl 100 mg/ml Solution for Injection Vetoquinol S.A. 31/10/1997 VM Unknown AU Solution for injection QJ01MA93 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Intravenous use Subcutaneous use Marbofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10521/024/001 VPA10521/024/001 Marbocyl 20 mg/ml Solution for Injection Vetoquinol S.A. 18/09/1998 VM Unknown AU Solution for injection QJ01MA93 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Intravenous use Subcutaneous use Marbofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10983/037/001 VPA10983/037/001 MARBOCYL FD, powder and solvent for solution for injection Vetoquinol Ireland Limited 18/02/2000 VM Unknown AU Powder and solvent for solution for injection QJ01MA93 Not Currently Available Intravenous use Subcutaneous use Marbofloxacin Prescription Only Medicine Cats Dogs Antibacterial VPA10521/031/002 VPA10521/031/002 Marbocyl P 20 mg Tablets Vetoquinol S.A. 19/04/2004 VM Unknown AU Tablet QJ01MA93 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Dogs Antibacterial VPA10521/031/001 VPA10521/031/001 Marbocyl P 5 mg Tablets Vetoquinol S.A. 19/04/2004 VM Unknown AU Tablet QJ01MA93 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Cats Dogs Antibacterial VPA10521/031/003 VPA10521/031/003 Marbocyl P 80 mg Tablets Vetoquinol S.A. 19/04/2004 VM Unknown AU Tablet QJ01MA93 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Dogs Antibacterial VPA10534/006/002 VPA10534/006/002 Marbodug 100 mg/ml Solution for Injection for Cattle and Pigs Emdoka 11/01/2013 VM Unknown AU Solution for injection QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Marbofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10534/006/001 VPA10534/006/001 Marbodug 20 mg/ml solution for injection for cattle and pigs Emdoka 11/01/2013 VM Unknown AU Solution for injection QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Marbofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA22664/100/001 VPA22664/100/001 Marbonor 100 mg/ml Solution for Injection for cattle and pig Norbrook Laboratories (Ireland) Limited 22/02/2013 VM Unknown AU Solution for injection QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Marbofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10495/003/001 VPA10495/003/001 Marbosyva 100 mg/ml solution for injection for cattle and pigs Laboratorios Syva S.A. 23/11/2012 VM Unknown AU Solution for injection QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Marbofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA20742/010/001 VPA20742/010/001 Marbotis 3mg/ml + 10mg/ml + 1mg/ml ear drops, suspension for dogs Vet-Agro Multi-Trade Company Sp z o.o. 15/03/2024 VM Unknown AU Ear drops, suspension QS02CA06 Hybrid application – differences in raw materials or in manufacturing processes of biological VMPs (Article 19(1)(c) of Regulation (EU) 2019/6) Auricular use Marbofloxacin Clotrimazole Dexamethasone acetate Prescription Only Medicine Dogs Antibacterial VPA10815/014/001 VPA10815/014/001 Marbox 100 mg/ml solution for injection for cattle and pigs Ceva Santé Animale 10/12/2010 VM Unknown AU Solution for injection QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Marbofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10774/014/002 VPA10774/014/002 Marfloxin 100 mg/ml solution for injection for cattle and pigs Krka, d.d., Novo mesto 26/08/2011 VM Unknown AU Solution for injection QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Marbofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10774/016/002 VPA10774/016/002 Marfloxin 20 mg tablets for dogs Krka, d.d., Novo mesto 03/05/2013 VM Not marketed AU Tablet QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Dogs Antibacterial VPA10774/016/001 VPA10774/016/001 Marfloxin 5 mg tablets for cats and dogs Krka, d.d., Novo mesto 03/05/2013 VM Not marketed AU Tablet QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Cats Dogs Antibacterial VPA10774/016/003 VPA10774/016/003 Marfloxin 80 mg tablets for dogs Krka, d.d., Novo mesto 03/05/2013 VM Not marketed AU Tablet QJ01MA93 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Marbofloxacin Prescription Only Medicine Dogs Antibacterial VPA25237/005/001 VPA25237/005/001 Maropicord 10 mg/ml solution for injection for dogs and cats Accord Healthcare B.V. 27/03/2026 VM Unknown AU Solution for injection QA04AD90 Generic application (Article 18 of Regulation (EU) 2019/6) Intravenous use Subcutaneous use Maropitant citrate monohydrate Prescription Only Medicine Cats Dogs Miscellaneous VPA10988/120/001 VPA10988/120/001 Mastavance 20 mg intramammary suspension for cattle (lactating cow) Virbac 09/01/2026 VM Unknown AU Intramammary suspension QG52X Full application (Article 8 of Regulation (EU) 2019/6) Intramammary use Hydrocortisone Aceponate Prescription Only Medicine Cattle Corticosteroid VPA10836/003/001 VPA10836/003/001 MASTERFLOX 40 mg/ml solution for injection for pigs FATRO S.p.A. 24/07/2015 VM Marketed AU Solution for injection QJ01MA93 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Marbofloxacin Prescription Only Medicine Pigs Antibacterial VPA22693/021/001 VPA22693/021/001 Mastermectin 10 mg/ml Solution for injection for cattle, sheep and pigs ECO Animal Health Europe Limited 14/06/2000 VM Unknown AU Solution for injection QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA22028/012/001 VPA22028/012/001 MASTIC DRY COW 600 mg intramammary suspension for cattle Bioveta, a.s. 22/05/2026 VM Unknown AU Intramammary suspension QJ51CF02 Hybrid application (Article 19(1) of Regulation (EU) 2019/6) Intramammary use Cloxacillin Benzathine Prescription Only Medicine Cattle Antibacterial VPA22028/005/001 VPA22028/005/001 MASTIC Lacto 200 mg + 50 mg + 10 mg intramammary suspension for cattle Bioveta, a.s. 10/01/2025 VM Unknown AU Intramammary suspension QJ51RV01 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Intramammary use Amoxicillin trihydrate potassium clavulanate Prednisolone Prescription Only Medicine Cattle Antibacterial VPA22028/006/001 VPA22028/006/001 Mastic Seal 2.6 g intramammary suspension for cattle Bioveta, a.s. 05/04/2024 VM Unknown AU Intramammary suspension QG52X Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Intramammary use Bismuth subnitrate, heavy Licensed Retailer Cattle Teat Dip/Seal VPA10996/205/001 VPA10996/205/001 Mastiplan LC, 300mg/20mg (Cefapirin/Prednisolone), intramammary suspension for lactating cows Intervet Ireland Limited 08/06/2007 VM Marketed AU Intramammary suspension QJ51RV01 Fixed combination application (Article 13b of Directive No 2001/82/EC) Intramammary use Cefapirin Prednisolone Prescription Only Medicine Cattle Antibacterial VPA22033/028/001 VPA22033/028/001 Maximec Horse Oral Paste 18.7 mg/g Bimeda Animal Health Limited 05/03/2004 VM Unknown AU Oral paste QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Horses Endectoparasiticides VPA10823/007/001 VPA10823/007/001 Maxoject LA 200 mg/ml Solution for Injection Chem-Pharm Limited 01/10/1998 VM Unknown AU Solution for injection QJ01AA06 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Oxytetracycline Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10786/011/002 VPA10786/011/002 Maxpramil 12.5 mg/125 mg tablets for dogs Laboratorios Karizoo S.A. 19/06/2026 VM Unknown AU Tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10786/011/001 VPA10786/011/001 Maxpramil 2.5 mg/25 mg tablets for small dogs and puppies Laboratorios Karizoo S.A. 19/06/2026 VM Unknown AU Tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10516/011/001 VPA10516/011/001 MAXYL 500 mg/g POWDER FOR USE IN DRINKING WATER FOR CHICKENS, TURKEYS, DUCKS AND PIGS Vetpharma Animal Health S.L. 24/10/2014 VM Marketed AU Powder for use in drinking water QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate Prescription Only Medicine Chickens Duck Pigs Turkeys Antibacterial VPA22033/064/001 VPA22033/064/001 Mectaject 10 mg/ml solution for injection for cattle, sheep and pigs Bimeda Animal Health Limited 20/12/2000 VM Unknown AU Solution for injection QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA22033/029/001 VPA22033/029/001 Mectaject Plus Solution for Injection Bimeda Animal Health Limited 24/09/2010 VM Unknown AU Solution for injection QP54AA51 Informed consent application (Article 13c of Directive No 2001/82/EC) Subcutaneous use Ivermectin Clorsulon Prescription Only Medicine Cattle Endectoparasiticides VPA10810/003/001 VPA10810/003/001 Medesedan 10 mg/ml solution for injection for horses and cattle CP-Pharma Handelsgesellschaft mbH 15/02/2008 VM Unknown AU Solution for injection QN05CM90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Detomidine hydrochloride Prescription Only Medicine Cattle Horses Neurological Preparations VPA10810/002/001 VPA10810/002/001 Medetor 1 mg/ml Solution for Injection for Dog and Cat CP-Pharma Handelsgesellschaft mbH 27/07/2007 VM Unknown AU Solution for injection QN05CM91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Medetomidine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10987/153/001 VPA10987/153/001 Medimec 0.5 %w/v Pour-on Solution Chanelle Pharmaceuticals Manufacturing Limited 03/12/2004 VM Unknown AU Pour-on solution QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10956/001/001 VPA10956/001/001 Megacal-M Injection Ballinskelligs Vet. Products Ltd 01/10/1991 VM Unknown AU Solution for injection QA12A Complete application (stand-alone) - Council Directive 81/851/EEC Intravenous use Subcutaneous use Calcium Phosphorous Magnesium Licensed Retailer Cattle Vitamins and minerals VPA10976/008/001 VPA10976/008/001 Megapen - Strep Injection Franklin Pharmaceuticals Ltd. 01/10/1987 VM Unknown AU Suspension for injection QJ01RA Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Procaine benzylpenicillin Dihydrostreptomycin sulphate Prescription Only Medicine Cattle Antibacterial VPA10774/061/002 VPA10774/061/002 Mektix 12.5 mg/125 mg chewable tablets for dogs weighing at least 5 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/061/004 VPA10774/061/004 Mektix 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 kg Krka, d.d., Novo mesto 17/09/2021 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10774/062/002 VPA10774/062/002 Mektix 16 mg/40 mg chewable tablets for cats weighing at least 2 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10774/061/001 VPA10774/061/001 Mektix 2.5 mg/25 mg chewable tablets for small dogs and puppies weighing at least 0.5 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/061/003 VPA10774/061/003 Mektix 2.5 mg/25 mg film-coated tablets for small dogs and puppies weighing at least 0.5 kg Krka, d.d., Novo mesto 17/09/2021 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10774/062/001 VPA10774/062/001 Mektix 4 mg/10 mg chewable tablets for small cats and kittens weighing at least 0.5 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10826/023/001 VPA10826/023/001 Menbutil 100 mg/ml solution for injection for cattle, pigs, horses, sheep and goats aniMedica GmbH 14/12/2018 VM AU Solution for injection QA05AX90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Menbutone Prescription Only Medicine Cattle Goats Horses Pigs Sheep Alimentary Tract Preparation VPA22622/012/001 VPA22622/012/001 Mepiblock 20 mg/ml solution for injection for horses Dechra Regulatory B.V. 15/12/2017 VM Unknown AU Solution for injection QN01BB03 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Epidural use Intraarticular use Mepivacaine hydrochloride Prescription Only Medicine Horses Neurological Preparations VPA23462/007/001 VPA23462/007/001 Mepidor 20 mg/ml solution for injection for horses VetViva Richter GmbH 05/01/2018 VM Unknown AU Solution for injection QN01BB03 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Epidural use Intraarticular use Mepivacaine hydrochloride Prescription Only Medicine Horses Neurological Preparations VPA10989/066/001 VPA10989/066/001 Metaxol 20/100 mg/ml solution for use in drinking water for pigs and chickens Eurovet Animal Health B.V. 08/07/2016 VM Unknown AU Oral solution QJ01EW11 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Trimethoprim Sulfamethoxazole Prescription Only Medicine Chickens Pigs Antibacterial VPA10980/025/001 VPA10980/025/001 Metaxx 0.25 mg chewable tablets for cats Alfasan Nederland B.V. 23/12/2022 VM Unknown AU Chewable tablet QM01AC06 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Meloxicam Prescription Only Medicine Cats N.S.A.I.D. VPA10980/036/001 VPA10980/036/001 Metaxx 0.5 mg/ml oral suspension for cats and guinea pigs Alfasan Nederland B.V. 28/03/2024 VM Unknown AU Oral suspension QM01AC06 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Meloxicam Prescription Only Medicine Cats Guinea pig N.S.A.I.D. VPA10980/035/001 VPA10980/035/001 Metaxx 1.5 mg/ml oral suspension for dogs Alfasan Nederland B.V. 28/03/2024 VM Unknown AU Oral suspension QM01AC06 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Meloxicam Prescription Only Medicine Dogs N.S.A.I.D. VPA10980/023/001 VPA10980/023/001 Metaxx 15 mg/ml oral suspension for horses Alfasan Nederland B.V. 03/02/2023 VM Unknown AU Oral suspension QM01AC06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Meloxicam Prescription Only Medicine Horses N.S.A.I.D. VPA10980/021/001 VPA10980/021/001 Metaxx 20 mg/ml solution for injection for cattle, pigs and horses Alfasan Nederland B.V. 25/11/2022 VM Unknown AU Solution for injection QM01AC06 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Meloxicam Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10980/022/001 VPA10980/022/001 Metaxx 5 mg/ml solution for injection for cattle, pigs, dogs and cats Alfasan Nederland B.V. 25/11/2022 VM Unknown AU Solution for injection QM01AC06 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Meloxicam Prescription Only Medicine Cats Cattle Dogs Pigs N.S.A.I.D. VPA10387/106/001 VPA10387/106/001 Methadyne 10 mg/ml solution for injection for dogs and cats Zoetis Belgium S.A. 08/09/2023 VM Unknown AU Solution for injection QN02AC90 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Subcutaneous use Methadone hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10475/009/001 VPA10475/009/001 Metomotyl 2.5 mg/ml solution for injection for cats and dogs Le Vet Beheer B.V. 12/09/2014 VM Not marketed AU Solution for injection QA03FA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Metoclopramide hydrochloride monohydrate Prescription Only Medicine Cats Dogs Neurological Preparations VPA10475/009/002 VPA10475/009/002 Metomotyl 5 mg/ml solution for injection for cats and dogs Le Vet Beheer B.V. 12/09/2014 VM Not marketed AU Solution for injection QA03FA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Metoclopramide hydrochloride monohydrate Prescription Only Medicine Cats Dogs Neurological Preparations VPA10996/053/001 VPA10996/053/001 Metricure 500 mg Intrauterine Suspension Intervet Ireland Limited 02/11/2001 VM Unknown AU Intrauterine suspension QG51AA05 Complete application (stand-alone) - Council Directive 81/851/EEC Intrauterine use Cephapirin Prescription Only Medicine Cattle Antibacterial VPA22622/037/001 VPA22622/037/001 Metrobactin 250 mg tablets for dogs and cats Dechra Regulatory B.V. 18/12/2015 VM Unknown AU Tablet QJ01XD01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Cats Dogs Antibacterial VPA22622/037/002 VPA22622/037/002 Metrobactin 500 mg tablets for dogs and cats Dechra Regulatory B.V. 18/12/2015 VM Unknown AU Tablet QJ01XD01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Cats Dogs Antibacterial VPA10491/012/001 VPA10491/012/001 Metrocare Flavour 250 mg tablets for dogs and cats Ecuphar N.V. 13/09/2019 VM AU Tablet QJ01XD01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Cats Dogs Antibacterial VPA10491/012/002 VPA10491/012/002 Metrocare Flavour 500 mg tablets for dogs and cats Ecuphar N.V. 13/09/2019 VM AU Tablet QJ01XD01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Cats Dogs Antibacterial VPA10810/021/003 VPA10810/021/003 Metrotab vet. Flavoured 1000 mg tablets for dogs CP-Pharma Handelsgesellschaft mbH 14/05/2021 VM Unknown AU Tablet QJ01XD01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Dogs Antibacterial VPA10810/021/001 VPA10810/021/001 Metrotab vet. Flavoured 250 mg tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 14/05/2021 VM Unknown AU Tablet QJ01XD01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Cats Dogs Antibacterial VPA10810/021/002 VPA10810/021/002 Metrotab vet. Flavoured 500 mg tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 14/05/2021 VM Unknown AU Tablet QJ01XD01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Cats Dogs Antibacterial VPA10509/020/001 VPA10509/020/001 Metrovis 100 mg tablets for dogs and cats Industrial Veterinaria S.A. 13/08/2019 VM AU Tablet QJ01XD01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Cats Dogs Antibacterial VPA10509/020/002 VPA10509/020/002 Metrovis 250 mg tablets for dogs and cats Industrial Veterinaria S.A. 13/08/2019 VM AU Tablet QJ01XD01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Cats Dogs Antibacterial VPA10509/020/003 VPA10509/020/003 Metrovis 750 mg tablets for dogs Industrial Veterinaria S.A. 13/08/2019 VM AU Tablet QJ01XD01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Metronidazole Prescription Only Medicine Cats Dogs Antibacterial VPA22020/019/001 VPA22020/019/001 Micotil 300 mg/ml Solution for Injection Elanco GmbH 26/09/1990 VM Marketed AU Solution for injection QJ01FA91 Complete application (stand-alone) - Council Directive 81/851/EEC Subcutaneous use Tilmicosin Prescription Only Medicine Cattle Sheep Antibacterial VPA10987/083/001 VPA10987/083/001 Milaxyn Plus Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 18/12/2009 VM Not marketed AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10987/083/002 VPA10987/083/002 Milaxyn Plus XL Tablets For Dogs Chanelle Pharmaceuticals Manufacturing Limited 12/04/2013 VM Not marketed AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10774/030/002 VPA10774/030/002 Milbactor 12.5 mg/125 mg tablets for dogs weighing at least 5 kg Krka, d.d., Novo mesto 09/01/2015 VM Unknown AU Tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/032/002 VPA10774/032/002 Milbactor 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg Krka, d.d., Novo mesto 13/02/2015 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10774/030/001 VPA10774/030/001 Milbactor 2.5 mg/25 mg tablets for small dogs and puppies weighing at least 0.5 kg Krka, d.d., Novo mesto 09/01/2015 VM Unknown AU Tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/032/001 VPA10774/032/001 Milbactor 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg Krka, d.d., Novo mesto 10/07/2015 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10815/072/002 VPA10815/072/002 Milbacyl 12.5 mg/125 mg chewable tablets for dogs Ceva Santé Animale 12/07/2024 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/073/002 VPA10815/073/002 Milbacyl 16 mg/40 mg film-coated tablets for cats Ceva Santé Animale 12/07/2024 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10815/072/001 VPA10815/072/001 Milbacyl 2.5 mg/25 mg chewable tablets for small dogs and puppies Ceva Santé Animale 12/07/2024 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/072/003 VPA10815/072/003 Milbacyl 25 mg/250 mg chewable tablets for large dogs Ceva Santé Animale 12/07/2024 VM Unknown AU Chewable tablet QP54AB51 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/073/001 VPA10815/073/001 Milbacyl 4 mg/10 mg film-coated tablets for small cats and kittens Ceva Santé Animale 12/07/2024 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10815/067/002 VPA10815/067/002 Milbeguard Duo 12.5 mg/125 mg chewable tablets for dogs Ceva Santé Animale 19/01/2024 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/068/002 VPA10815/068/002 Milbeguard Duo 16 mg/40 mg film-coated tablets for cats Ceva Santé Animale 19/01/2024 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10815/067/001 VPA10815/067/001 Milbeguard Duo 2.5 mg/25 mg chewable tablets for small dogs and puppies Ceva Santé Animale 19/01/2024 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/067/003 VPA10815/067/003 Milbeguard Duo 25 mg/250 mg chewable tablets for large dogs Ceva Santé Animale 19/01/2024 VM Unknown AU Chewable tablet QP54AB51 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/068/001 VPA10815/068/001 Milbeguard Duo 4 mg/10 mg film-coated tablets for small cats and kittens Ceva Santé Animale 19/01/2024 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA22020/009/002 VPA22020/009/002 MILBEMAX 16 mg/40 mg film-coated tablets for cats Elanco GmbH 22/04/2016 VM Unknown AU Film-coated tablet QP54AB51 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA22020/009/001 VPA22020/009/001 MILBEMAX 4 mg/10 mg film-coated tablets for small cats and kittens Elanco GmbH 22/04/2016 VM Unknown AU Film-coated tablet QP54AB51 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA22020/008/004 VPA22020/008/004 MILBEMAX chewable tablets for dogs Elanco GmbH 22/04/2016 VM Unknown AU Chewable tablet QP54AB51 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA22020/008/003 VPA22020/008/003 MILBEMAX chewable tablets for small dogs and puppies Elanco GmbH 22/04/2016 VM Unknown AU Chewable tablet QP54AB51 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA22020/008/001 VPA22020/008/001 MILBEMAX tablets for small dogs and puppies Elanco GmbH 22/04/2016 VM Unknown AU Tablet QP54AB51 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA22020/008/002 VPA22020/008/002 MILBEMAX® tablets for dogs Elanco GmbH 22/04/2016 VM Unknown AU Tablet QP54AB51 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA25201/003/002 VPA25201/003/002 Milbemycin oxime/Praziquantel Alfamed 12.5 mg/125 mg film-coated tablets for dogs Alfamed 16/08/2024 VM Unknown AU Film-coated tablet QP54AB51 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA25201/002/002 VPA25201/002/002 Milbemycin oxime/Praziquantel Alfamed 16 mg/40 mg film-coated tablets for cats Alfamed 16/08/2024 VM Unknown AU Film-coated tablet QP54AB51 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA25201/003/001 VPA25201/003/001 Milbemycin oxime/Praziquantel Alfamed 2.5 mg/25 mg film-coated tablet for small dogs and puppies Alfamed 16/08/2024 VM Unknown AU Film-coated tablet QP54AB51 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA25201/002/001 VPA25201/002/001 Milbemycin oxime/Praziquantel Alfamed 4 mg/10 mg film-coated tablets for small cats and kittens Alfamed 16/08/2024 VM Unknown AU Film-coated tablet QP54AB51 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA25201/001/002 VPA25201/001/002 Milbemycin oxime Praziquantel Chew Alfamed 12.5 mg/125.0 mg chewable tablets for dogs Alfamed 10/05/2024 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA25201/001/001 VPA25201/001/001 Milbemycin oxime Praziquantel Chew Alfamed 2.5 mg/25.0 mg chewable tablets for small dogs and puppies Alfamed 10/05/2024 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA25201/001/003 VPA25201/001/003 Milbemycin oxime Praziquantel Chew Alfamed 25.0 mg/250.0 mg chewable tablets for large dogs Alfamed 10/05/2024 VM Unknown AU Chewable tablet QP54AB51 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/069/002 VPA10815/069/002 Milbepar 12.5 mg/125 mg chewable tablets for dogs Ceva Santé Animale 12/07/2024 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/071/002 VPA10815/071/002 Milbepar 16 mg/40 mg film-coated tablets for cats Ceva Santé Animale 12/07/2024 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10815/069/001 VPA10815/069/001 Milbepar 2.5 mg/25 mg chewable tablets for small dogs and puppies Ceva Santé Animale 12/07/2024 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/069/003 VPA10815/069/003 Milbepar 25 mg/250 mg chewable tablets for large dogs Ceva Santé Animale 12/07/2024 VM Unknown AU Chewable tablet QP54AB51 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/071/001 VPA10815/071/001 Milbepar 4 mg/10 mg film-coated tablets for small cats and kittens Ceva Santé Animale 12/07/2024 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10987/181/001 VPA10987/181/001 Milbetab 12.5 mg/125 mg Chewable Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 14/03/2025 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10987/135/001 VPA10987/135/001 Milbetab 12.5 mg/125 mg Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 14/06/2019 VM AU Tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10987/173/001 VPA10987/173/001 Milbetab 16 mg/40 mg film-coated tablets for cats Chanelle Pharmaceuticals Manufacturing Limited 08/11/2024 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10987/181/002 VPA10987/181/002 Milbetab 2.5 mg/25 mg Chewable Tablets for small dogs and puppies Chanelle Pharmaceuticals Manufacturing Limited 14/03/2025 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10987/179/001 VPA10987/179/001 Milbetab 2.5 mg/25 mg Tablets for small dogs and puppies Chanelle Pharmaceuticals Manufacturing Limited 11/04/2025 VM Unknown AU Tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10987/173/002 VPA10987/173/002 Milbetab 4 mg/10 mg film coated tablets for small cats and kittens Chanelle Pharmaceuticals Manufacturing Limited 08/11/2024 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10987/075/001 VPA10987/075/001 Milbotyl 300 mg/ml solution for injection Chanelle Pharmaceuticals Manufacturing Limited 25/11/2009 VM Marketed AU Solution for injection QJ01FA91 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Tilmicosin Prescription Only Medicine Cattle Sheep Antibacterial VPA10774/063/004 VPA10774/063/004 Milgusto 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 kg Krka, d.d., Novo mesto 17/09/2021 VM Unknown AU Film-coated tablet QP54AB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/064/002 VPA10774/064/002 Milgusto 16 mg/40 mg chewable tablets for cats weighing at least 2 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10774/063/003 VPA10774/063/003 Milgusto 2.5 mg/25 mg film-coated tablets for small dogs and puppies weighing at least 0.5 kg Krka, d.d., Novo mesto 17/09/2021 VM Unknown AU Film-coated tablet QP54AB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/064/001 VPA10774/064/001 Milgusto 4 mg/10 mg chewable tablets for small cats and kittens weighing at least 0.5 kg Krka, d.d., Novo mesto 27/07/2018 VM Not marketed AU Chewable tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10987/182/001 VPA10987/182/001 Milipraz 12.5 mg/125 mg Chewable Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 14/03/2025 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10987/136/001 VPA10987/136/001 Milipraz 12.5 mg/125 mg Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 14/06/2019 VM AU Tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10987/174/001 VPA10987/174/001 Milipraz 16 mg/40 mg film-coated tablets for cats Chanelle Pharmaceuticals Manufacturing Limited 08/11/2024 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10987/182/002 VPA10987/182/002 Milipraz 2.5 mg/25 mg Chewable Tablets for small dogs and puppies Chanelle Pharmaceuticals Manufacturing Limited 14/03/2025 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10987/180/001 VPA10987/180/001 Milipraz 2.5 mg/25 mg Tablets for small dogs and puppies Chanelle Pharmaceuticals Manufacturing Limited 11/04/2025 VM Unknown AU Tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10987/174/002 VPA10987/174/002 Milipraz 4 mg/10 mg film-coated tablets for small cats and kittens Chanelle Pharmaceuticals Manufacturing Limited 08/11/2024 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endoparasiticide VPA10774/029/002 VPA10774/029/002 Milprazon 12.5 mg/125 mg tablets for dogs weighing at least 5 kg Krka, d.d., Novo mesto 06/03/2015 VM Unknown AU Tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/031/002 VPA10774/031/002 Milprazon 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg Krka, d.d., Novo mesto 01/05/2015 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10774/029/001 VPA10774/029/001 Milprazon 2.5 mg/25 mg tablets for small dogs and puppies weighing at least 0.5 kg Krka, d.d., Novo mesto 06/03/2015 VM Unknown AU Tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10774/031/001 VPA10774/031/001 Milprazon 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg Krka, d.d., Novo mesto 24/04/2015 VM Unknown AU Film-coated tablet QP54AB51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10988/095/002 VPA10988/095/002 Milpro 12.5 mg/125 mg film-coated tablets for dogs Virbac 18/07/2014 VM Unknown AU Tablet QP54AB51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10988/096/002 VPA10988/096/002 Milpro 16 mg/40 mg film-coated tablets for cats Virbac 15/08/2014 VM Unknown AU Tablet QP54AB51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10988/095/001 VPA10988/095/001 Milpro 2.5 mg/25 mg film-coated tablets for small dogs and puppies Virbac 18/07/2014 VM Unknown AU Tablet QP54AB51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endectoparasiticides VPA10988/096/001 VPA10988/096/001 Milpro 4 mg/10 mg film-coated tablets for small cats and kittens Virbac 15/08/2014 VM Unknown AU Tablet QP54AB51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Cats Endectoparasiticides VPA10988/118/002 VPA10988/118/002 Milpro Chewy 12.5 mg/125.0 mg chewable tablets for dogs Virbac 17/05/2024 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10988/118/001 VPA10988/118/001 Milpro Chewy 2.5 mg/25.0 mg chewable tablets for small dogs and puppies Virbac 17/05/2024 VM Unknown AU Chewable tablet QP54AB51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10988/118/003 VPA10988/118/003 Milpro Chewy 25.0 mg/250.0 mg chewable tablets for large dogs Virbac 17/05/2024 VM Unknown AU Chewable tablet QP54AB51 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Milbemycin oxime Praziquantel Prescription Only Medicine Dogs Endoparasiticide VPA10815/043/001 VPA10815/043/001 Modulis 100 mg/ml oral solution for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Oral solution QL04AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Ciclosporin Prescription Only Medicine Dogs Miscellaneous VPA10396/001/001 VPA10396/001/001 Morlam Intravaginal Sponge Laboratorios Ovejero S.A.U. 01/10/1987 VM Unknown AU Medicated sponge QG03DA02 Full application (Article 12(3) of Directive No 2001/82/EC) Vaginal use Medroxyprogesterone acetate Prescription Only Medicine Sheep Hormone VPA10826/007/001 VPA10826/007/001 Morphasol 4 mg/ml solution for injection for dogs and cats aniMedica GmbH 18/12/2009 VM Not marketed AU Solution for injection QN02AF01 Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Butorphanol tartrate Prescription Only Medicine Cats Dogs Neurological Preparations VPA10817/003/001 VPA10817/003/001 MOXAPULVIS 500 mg/g powder for use in drinking water V.M.D. 16/03/2018 VM Marketed AU Powder for use in drinking water QJ01CA04 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate Prescription Only Medicine Chickens Duck Pigs Turkeys Antibacterial VPA22664/140/002 VPA22664/140/002 Moxiclear 100 mg + 25 mg spot-on solution for medium dogs Norbrook Laboratories (Ireland) Limited 24/11/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA22664/140/003 VPA22664/140/003 Moxiclear 250 mg + 62.5 mg spot-on solution for large dogs Norbrook Laboratories (Ireland) Limited 24/11/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA22664/140/001 VPA22664/140/001 Moxiclear 40 mg + 10 mg spot-on solution for small dogs Norbrook Laboratories (Ireland) Limited 24/11/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA22664/139/001 VPA22664/139/001 Moxiclear 40 mg + 4 mg spot-on solution for small cats and ferrets Norbrook Laboratories (Ireland) Limited 24/11/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Cats Ferrets Endectoparasiticides VPA22664/140/004 VPA22664/140/004 Moxiclear 400 mg + 100 mg spot-on solution for very-large dogs Norbrook Laboratories (Ireland) Limited 24/11/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA22664/139/002 VPA22664/139/002 Moxiclear 80 mg + 8 mg spot-on solution for large cats Norbrook Laboratories (Ireland) Limited 24/11/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Cats Endectoparasiticides VPA22033/079/001 VPA22033/079/001 Moxisolv LA 100 mg/ml Solution for Injection for Cattle Bimeda Animal Health Limited 31/03/2023 VM Unknown AU Solution for injection QP54AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Moxidectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/111/001 VPA10987/111/001 Moxodex 1 mg/ml oral solution for sheep Chanelle Pharmaceuticals Manufacturing Limited 25/08/2017 VM Marketed AU Oral solution QP54AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Moxidectin Prescription Only Medicine Sheep Endectoparasiticides VPA10987/129/001 VPA10987/129/001 Moxodex 5 mg/ml Pour-on solution for cattle Chanelle Pharmaceuticals Manufacturing Limited 24/01/2020 VM Unknown AU Pour-on solution QP54AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Moxidectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/171/001 VPA10987/171/001 Moxodex LA 100 mg/ml Solution for Injection for Cattle Chanelle Pharmaceuticals Manufacturing Limited 17/07/2023 VM Unknown AU Solution for injection QP54AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Moxidectin Prescription Only Medicine Cattle Endectoparasiticides VPA22033/030/001 VPA22033/030/001 Multimast Dry Cow Intramammary Suspension Bimeda Animal Health Limited 09/12/2013 VM Unknown AU Intramammary suspension QJ51RC Informed consent application (Article 13c of Directive No 2001/82/EC) Intramammary use Neomycin sulphate Penethamate hydriodide Procaine benzylpenicillin Prescription Only Medicine Cattle Antibacterial VPA10431/001/001 VPA10431/001/001 Multimin Solution for Injection for Cattle Warburton Technology Limited 10/07/2015 VM Unknown AU Solution for injection QA12CX99 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Zinc oxide Manganese carbonate Copper(II) carbonate Sodium selenite Prescription Only Medicine Cattle Vitamins and minerals VPA22033/065/001 VPA22033/065/001 Multishield DC Intramammary Suspension for Cows Bimeda Animal Health Limited 25/01/2013 VM Temporarily Not Marketed AU Intramammary suspension QJ51RC22 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramammary use Neomycin sulphate Penethamate hydriodide Procaine benzylpenicillin Prescription Only Medicine Cattle Antibacterial VPA10988/113/001 VPA10988/113/001 MUSTELIGEN D lyophilisate and solvent for suspension for injection for ferrets Virbac S.A. 26/06/2020 VM Unknown AU Lyophilisate and solvent for suspension for injection QI20DD01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Canine Distemper Virus, Strain Lederle, Live Prescription Only Medicine Ferrets Immunological VPA10790/007/001 VPA10790/007/001 MYCOFLOR 200 mg/ml solution for use in drinking water for pigs SP Veterinaria, S.A. 29/04/2016 VM Unknown AU Solution for use in drinking water QJ01BA90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Florfenicol Prescription Only Medicine Pigs Antibacterial VPA10790/004/001 VPA10790/004/001 MYCOFLOR 300 mg/ml solution for injection for cattle and pigs SP Veterinaria, S.A. 21/12/2011 VM Marketed AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Florfenicol Prescription Only Medicine Cattle Pigs Antibacterial VPA10990/047/001 VPA10990/047/001 Mycomas 100 mg/ml Solution for use in drinking water Univet Limited 28/10/2016 VM Marketed AU Solution for use in drinking water QJ01MA90 Informed consent application (Article 13c of Directive No 2001/82/EC) In drinking water use Enrofloxacin Prescription Only Medicine Chickens Turkeys Antibacterial VPA10475/027/001 VPA10475/027/001 Myodine 25 mg/ml solution for injection for dogs and cats Le Vet Beheer B.V. 28/07/2017 VM Unknown AU Solution for injection QA14AB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Nandrolone laurate Prescription Only Medicine Cats Dogs Hormone VPA10475/042/001 VPA10475/042/001 Myolone 25 mg/ml solution for injection for dogs and cats Le Vet Beheer B.V. 11/06/2021 VM Unknown AU Solution for injection QA14AB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Nandrolone laurate Prescription Only Medicine Cats Dogs Hormone VPA10846/004/001 VPA10846/004/001 MYPRAVAC SUISSuspension for injection Laboratorios Hipra S.A. 02/05/2003 VM Unknown AU Suspension for injection QI09AB13 Fixed combination application (Article 13b of Directive No 2001/82/EC) Intramuscular use Inactivated Mycoplasma hyopneumoniae strain J Licensed Retailer Pigs Immunological - Inactivated Vaccine VPA10810/015/001 VPA10810/015/001 Nandrosol 25 mg/ml solution for injection for dogs and cats CP-Pharma Handelsgesellschaft mbH 27/09/2019 VM Unknown AU Solution for injection QA14AB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Nandrolone laurate Prescription Only Medicine Cats Dogs Hormone VPA10782/046/001 VPA10782/046/001 Nanotrim 464.2 mg/g + 100 mg/g powder for use in drinking water/milk for chickens, turkeys, pigs and cattle Huvepharma NV 10/01/2025 VM Unknown AU Powder for use in drinking water/milk QJ01EW12 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Sulfachlorpyridazine sodium Trimethoprim Prescription Only Medicine Cattle Chickens Pigs Turkeys Antibacterial VPA10521/032/001 VPA10521/032/001 Narketan-10 100 mg/ml Solution for Injection Vetoquinol S.A. 01/10/2000 VM Unknown AU Solution for injection QN01AX03 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Intravenous use Subcutaneous use Ketamine hydrochloride Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA10516/005/001 VPA10516/005/001 NEFOTEK 100 mg/ml solution for injection for cattle, horses and pigs Vetpharma Animal Health S.L. 10/02/2012 VM Marketed AU Solution for injection QM01AE03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10815/031/002 VPA10815/031/002 Nelio 2.5 mg Tablet for Cats Ceva Santé Animale 11/11/2016 VM Unknown AU Tablet QC09AA07 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Cats Cardiovascular VPA10815/032/002 VPA10815/032/002 Nelio 20 mg Tablet for dogs Ceva Santé Animale 25/09/2009 VM Unknown AU Tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril Prescription Only Medicine Dogs Cardiovascular VPA10815/031/001 VPA10815/031/001 Nelio 5 mg tablet for cats Ceva Santé Animale 03/06/2016 VM Unknown AU Tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril hydrochloride Prescription Only Medicine Cats Cardiovascular VPA10815/032/001 VPA10815/032/001 Nelio 5 mg Tablet for Dogs Ceva Santé Animale 25/09/2009 VM Unknown AU Tablet QC09AA07 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Benazepril Prescription Only Medicine Dogs Cardiovascular VPA10475/005/001 VPA10475/005/001 Nematel-P 439 mg/g oral paste for horses Le Vet Beheer B.V. 04/05/2012 VM Marketed AU Oral paste QP52AF02 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Pyrantel embonate Prescription Only Medicine Horses Endoparasiticide VPA10454/070/001 VPA10454/070/001 NEMOVAC Boehringer Ingelheim Vetmedica GmbH 08/06/2000 VM Unknown AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Live pneumovirus, PL21 strain Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10436/003/001 VPA10436/003/001 NEOMAY 500 000 IU/g powder for use in drinking water/milk replacer Laboratorios Maymo S.A.U. 23/12/2016 VM Unknown AU Powder for use in drinking water/milk QA07AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Neomycin Prescription Only Medicine Cattle Chickens Duck Goose Partridge Pigs Quail Turkeys Antibacterial VPA10996/006/002 VPA10996/006/002 Neopen Suspension for Injection Intervet Ireland Limited 01/10/1987 VM Unknown AU Suspension for injection QJ01RA01 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Neomycin sulphate Procaine benzylpenicillin Prescription Only Medicine Cattle Horses Pigs Antibacterial VPA10988/090/001 VPA10988/090/001 NEOPRINIL POUR-ON 5 mg/ml pour-on solution for cattle Virbac 12/09/2014 VM Marketed AU Pour-on solution QP54AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Endectoparasiticides VPA10402/004/001 VPA10402/004/001 NEOSKILAB 1.5 mg/ml solution for injection for cattle, sheep, goats and horses Labiana Life Sciences, S.A. 11/06/2021 VM Unknown AU Solution for injection QN07AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Neostigmine Metilsulfate Prescription Only Medicine Cattle Goats Horses Sheep Alimentary Tract Preparation VPA10816/013/002 VPA10816/013/002 Nerfasin 100 mg/ml, solution for injection for cattle and horses Le Vet BV 18/05/2012 VM Unknown AU Solution for injection QN05CM92 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Xylazine Hydrochloride Prescription Only Medicine Cattle Horses Neurological Preparations VPA10816/013/001 VPA10816/013/001 Nerfasin 20 mg/ml, solution for injection for cattle, horses, dogs and cats Le Vet BV 18/05/2012 VM Unknown AU Solution for injection QN05CM92 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Xylazine Hydrochloride Prescription Only Medicine Cats Cattle Dogs Horses Neurological Preparations VPA25460/004/001 VPA25460/004/001 Nexmectin 18.7 mg/g Oral Paste for Horses Acme Drugs S.r.l. 21/06/2019 VM AU Oral paste QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Horses Endectoparasiticides VPA22028/011/001 VPA22028/011/001 NEXPRAZ DUO 18.7 mg/g + 140.3 mg/g Oral Paste for Horses Bioveta, a.s. 27/02/2026 VM Unknown AU Oral paste QP54AA51 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Oral use Ivermectin Praziquantel Prescription Only Medicine Horses Endectoparasiticides VPA10463/009/001 VPA10463/009/001 Nextmune concentrate and solvent for suspension for injection for chickens CEVA-Phylaxia Veterinary Biologicals Co. Ltd 07/08/2020 VM Unknown AU Concentrate and solvent for suspension for injection QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) In ovo Subcutaneous use Live attenuated IBD virus, serotype 1, strain G-61 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10516/007/001 VPA10516/007/001 Nifencol 300 mg/ml solution for injection for cattle and pigs Vetpharma Animal Health S.L. 18/10/2013 VM Marketed AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Florfenicol Prescription Only Medicine Cattle Pigs Antibacterial VPA10989/062/001 VPA10989/062/001 NIMATEK 100 mg/ml, Solution for injection for dogs, cats and horses Eurovet Animal Health B.V. 09/05/2014 VM Unknown AU Solution for injection QN01AX03 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Ketamine hydrochloride Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA10996/131/001 VPA10996/131/001 Nobilis CAV P4 Intervet Ireland Limited 28/10/2003 VM Unknown AU Lyophilisate and solvent for suspension for injection QI01AD04 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Chick anaemia agent virus strain 26p4 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10996/083/001 VPA10996/083/001 Nobilis E.coli inac emulsion for injection for chickens Intervet Ireland Limited 06/06/2000 VM Unknown AU Emulsion for injection QI01AB05 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use F11-antigen (E. coli fimbrial antigen) FT-antigen (E. coli flagellar toxin antigen) Prescription Only Medicine Chickens Immunological - Inactivated Vaccine VPA10996/134/001 VPA10996/134/001 Nobilis Gumboro 228E lyophilisate for use in drinking water for chickens Intervet Ireland Limited 12/11/2004 VM Unknown AU Powder for oral solution QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Gumboro disease virus strain 228e Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10996/133/001 VPA10996/133/001 Nobilis Gumboro D78 lyophilisate for use in drinking water for chickens Intervet Ireland Limited 04/04/2003 VM Unknown AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Gumboro disease virus strain D78 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10996/136/001 VPA10996/136/001 Nobilis IB Ma5 Intervet Ireland Limited 19/02/2003 VM Marketed AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Oculonasal use Oral use Live attenuated IB virus strain Ma5 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10996/094/001 VPA10996/094/001 Nobilis IB+ND+EDS emulsion for injection for chickens Intervet Ireland Limited 28/10/2005 VM Unknown AU Emulsion for injection QI01AA13 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Infectious bronchitis virus strain m41 inactivated Inactivated ND virus strain clone 30 inducing Inactivated egg drop syndrome’76 inducing Prescription Only Medicine Chickens Immunological - Inactivated Vaccine VPA10996/091/001 VPA10996/091/001 Nobilis ND Clone 30 live lyophilisate for oculonasal suspension/use in drinking water for chickens and turkeys. Intervet Ireland Limited 31/08/2004 VM Unknown AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD06 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Live newcastle disease virus clone 30 Prescription Only Medicine Chickens Turkeys Immunological - Live Vaccine VPA10996/190/001 VPA10996/190/001 Nobilis Rhino CV Intervet Ireland Limited 17/06/2005 VM Temporarily Not Marketed AU Lyophilisate for oculonasal suspension QI01AD01 Full application (Article 12(3) of Directive No 2001/82/EC) Nasal use Ocular use Oral use Live attenuated avian rhinotracheitis virus strain trt 11/94 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10996/087/001 VPA10996/087/001 Nobilis RT+IBmulti+G+ND Intervet Ireland Limited 24/08/2000 VM Unknown AU Emulsion for injection QI01AA18 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Infectious bronchitis virus strain M41 Infectious bronchitis virus strain 249g Avian rhinotracheitis virus strain But1 #8544 (subgroup A) Infectious bursal disease virus strain D78 Newcastle disease virus strain clone 30 Prescription Only Medicine Chickens Immunological - Inactivated Vaccine VPA10996/181/001 VPA10996/181/001 Nobilis RT+IBmulti+ND+EDS Intervet Ireland Limited 03/11/2004 VM Unknown AU Emulsion for injection QI01AA18 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Infectious bronchitis virus strain M41 (pre-inactivation) Infectious bronchitis virus strain 249g Avian rhinotracheitis strain But1 #8544 Egg drop syndrome 76 strain bc14 Newcastle disease virus strain clone 30 Prescription Only Medicine Chickens Immunological - Inactivated Vaccine VPA10996/174/001 VPA10996/174/001 Nobivac DHP lyophilisate and solvent for suspension for injection for dogs Intervet Ireland Limited 12/11/2004 VM Marketed AU Lyophilisate and solvent for suspension for injection QI07AD02 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Canine distemper virus, strain onderstepoort Canine adenovirus type 2 strain manhattan lpv3 (live) Canine parvovirus strain 154 (live) Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10996/166/001 VPA10996/166/001 Nobivac DHPPi Intervet Ireland Limited 03/06/2005 VM Unknown AU Lyophilisate for solution for injection QI07AD04 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Canine distemper virus strain ondertespoort (live) Canine adenovirus type 2 strain manhattan lpv3 (live) Canine parvovirus strain 154 (live) Canine parainfluenza virus strain Cornell (Live) Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10996/182/001 VPA10996/182/001 Nobivac Ducat lyophilisate and solvent for suspension for injection, for cats Intervet Ireland Limited 14/01/2005 VM Marketed AU Lyophilisate and solvent for suspension for injection QI06AD03 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Live feline calicivirus, strain F9 Live feline rhinotracheitis virus strain G2620A Prescription Only Medicine Cats Immunological - Live Vaccine VPA10996/129/001 VPA10996/129/001 Nobivac KC nasal drops, lyophilisate and solvent for suspension for dogs Intervet Ireland Limited 22/01/2001 VM Unknown AU Nasal drops, lyophilisate and solvent for suspension QI07AF Full application (Article 12(3) of Directive No 2001/82/EC) Intranasal use Nasal use Bordetella bronchiseptica Canine parainfluenza Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10996/169/001 VPA10996/169/001 Nobivac Lepto 2 Suspension for Injection for Dogs Intervet Ireland Limited 03/03/2004 VM Unknown AU Suspension for injection QI07AB01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Leptospira interrogans serogroup Canicola; serovar portland-vere, strain Ca-12-000 Leptospira interrogans serogroup icterohaemorrhagiae strain 820k Prescription Only Medicine Dogs Immunological - Inactivated Vaccine VPA10996/167/001 VPA10996/167/001 Nobivac Parvo-C Intervet Ireland Limited 05/03/2004 VM Unknown AU Lyophilisate and solvent for suspension for injection QI07AD01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Canine parvovirus attenuated strain 154 Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10996/289/001 VPA10996/289/001 Nobivac Pi lyophilisate and solvent for suspension for injection for dogs Intervet Ireland Limited 14/04/2022 VM Unknown AU Lyophilisate and solvent for suspension for injection QI07AD08 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Canine parainfluenza virus strain Cornell (Live) Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10996/170/001 VPA10996/170/001 Nobivac Rabies suspension for injection for dogs and cats Intervet Ireland Limited 10/08/2004 VM Unknown AU Suspension for injection QI07AA02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Inactivated rabies virus antigen suspension Prescription Only Medicine Cats Dogs Immunological - Inactivated Vaccine VPA10996/277/002 VPA10996/277/002 Nobivac Respira Bb suspension for injection for dogs Intervet Ireland Limited 25/08/2020 VM Unknown AU Suspension for injection QI07AB03 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Bordetella Bronchiseptica Fimbriae Prescription Only Medicine Dogs Immunological - Inactivated Vaccine VPA10996/277/001 VPA10996/277/001 Nobivac Respira Bb suspension for injection in pre-filled syringe for dogs Intervet Ireland Limited 25/08/2020 VM Unknown AU Suspension for injection in pre-filled syringe QI07AB03 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Bordetella Bronchiseptica Fimbriae Prescription Only Medicine Dogs Immunological - Inactivated Vaccine VPA10996/177/001 VPA10996/177/001 Nobivac Solvent Intervet Ireland Limited 03/10/2003 VM Unknown AU Solvent for parenteral use QV07AB Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Prescription Only Medicine Cats Dogs Immunological - Diluent VPA10996/204/001 VPA10996/204/001 Nobivac Tricat Trio, lyophilisate and solvent for suspension for injection, for cats Intervet Ireland Limited 28/02/2007 VM Marketed AU Lyophilisate and solvent for suspension for injection QI06AD04 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Feline calicivrus, strain f9 live attenuated Feline herpes virus type 1, strain g2620a live attenuated Feline panleucopenia virus, strain mw-1 live attenuated Prescription Only Medicine Cats Immunological - Live Vaccine VPA22664/097/002 VPA22664/097/002 Norbrook Fipronil 134 mg Spot-On Solution for Medium Dogs Norbrook Laboratories (Ireland) Limited 06/07/2012 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/097/003 VPA22664/097/003 Norbrook Fipronil 268 mg Spot-On Solution for Large Dogs Norbrook Laboratories (Ireland) Limited 06/07/2012 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/097/004 VPA22664/097/004 Norbrook Fipronil 402 mg Spot-On Solution for Very Large Dogs Norbrook Laboratories (Ireland) Limited 06/07/2012 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/096/001 VPA22664/096/001 Norbrook Fipronil 50 mg Spot-On Solution for cats Norbrook Laboratories (Ireland) Limited 06/07/2012 VM Marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Cats Ectoparasiticide VPA22664/097/001 VPA22664/097/001 Norbrook Fipronil 67 mg Spot-On Solution for Small Dogs Norbrook Laboratories (Ireland) Limited 06/07/2012 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/138/002 VPA22664/138/002 Norbrook Fipronil and (S)-Methoprene 134 mg/120.6 mg spot-on solution for medium dogs Norbrook Laboratories (Ireland) Limited 26/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Dogs Ectoparasiticide VPA22664/138/003 VPA22664/138/003 Norbrook Fipronil and (S)-Methoprene 268 mg/241.2 mg spot-on solution for large dogs Norbrook Laboratories (Ireland) Limited 26/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Dogs Ectoparasiticide VPA22664/138/004 VPA22664/138/004 Norbrook Fipronil and (S)-Methoprene 402 mg/361.8 mg spot-on solution for very large dogs Norbrook Laboratories (Ireland) Limited 26/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Dogs Ectoparasiticide VPA22664/133/001 VPA22664/133/001 Norbrook Fipronil and (S)-Methoprene 50 mg/60 mg spot-on solution for cats and ferrets Norbrook Laboratories (Ireland) Limited 26/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Cats Ferrets Ectoparasiticide VPA22664/138/001 VPA22664/138/001 Norbrook Fipronil and (S)-Methoprene 67 mg/60.3 mg spot-on solution for small dogs Norbrook Laboratories (Ireland) Limited 26/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Licensed Retailer Dogs Ectoparasiticide VPA22664/093/001 VPA22664/093/001 Norfenicol 300 mg/ml Solution for Injection for Cattle and Pigs Norbrook Laboratories (Ireland) Limited 18/05/2012 VM Unknown AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Florfenicol Prescription Only Medicine Cattle Pigs Antibacterial VPA22664/145/001 VPA22664/145/001 Normazole 5 mg/ml Oral Solution for Cats Norbrook Laboratories (Ireland) Limited 30/11/2018 VM Unknown AU Oral solution QH03BB02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Thiamazole Prescription Only Medicine Cats Hormone VPA22664/073/001 VPA22664/073/001 Norocarp 50 mg/ml Solution for Injection for Cattle Norbrook Laboratories (Ireland) Limited 09/09/2005 VM Unknown AU Solution for injection QM01AE91 Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Cattle N.S.A.I.D. VPA22664/012/001 VPA22664/012/001 Norocillin 300 mg/ml Suspension for Injection Norbrook Laboratories (Ireland) Limited 01/10/1987 VM Unknown AU Suspension for injection QJ01CE01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Procaine benzylpenicillin Prescription Only Medicine Cattle Horses Pigs Sheep Antibacterial VPA22664/072/002 VPA22664/072/002 Noroclav 250 mg Tablets for dogs Norbrook Laboratories (Ireland) Limited 28/05/2004 VM Unknown AU Tablet QJ01CR02 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA22664/072/001 VPA22664/072/001 Noroclav 50 mg Tablets for Dogs and Cats Norbrook Laboratories (Ireland) Limited 28/05/2004 VM Unknown AU Tablet QJ01CR02 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA22664/082/001 VPA22664/082/001 Noroclav 500 mg Palatable Tablets for Dogs Norbrook Laboratories (Ireland) Limited 05/10/2007 VM Unknown AU Tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Dogs Antibacterial VPA22664/058/001 VPA22664/058/001 Noroclav Injection for Cattle, Dogs and Cats Norbrook Laboratories (Ireland) Limited 27/09/2002 VM Unknown AU Suspension for injection QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cattle Dogs Cats Antibacterial VPA22664/090/001 VPA22664/090/001 Noroclav Intramammary Suspension for Lactating Cows Norbrook Laboratories (Ireland) Limited 30/11/2018 VM AU Intramammary suspension QJ51RV01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Amoxicillin trihydrate potassium clavulanate Prednisolone Prescription Only Medicine Cattle Antibacterial VPA22664/011/001 VPA22664/011/001 Noroclox DC Intramammary Suspension Norbrook Laboratories (Ireland) Limited 01/10/1987 VM Unknown AU Intramammary suspension QJ51CF02 Informed consent (abridged application) - Council Directive 81/851/EEC Intramammary use Cloxacillin Benzathine Prescription Only Medicine Cattle Antibacterial VPA22664/043/001 VPA22664/043/001 Noroclox DC Xtra Intramammary Suspension Norbrook Laboratories (Ireland) Limited 15/05/1996 VM Unknown AU Intramammary suspension QJ51CF02 Informed consent (abridged application) - Council Directive 81/851/EEC Intramammary use Cloxacillin Benzathine Prescription Only Medicine Cattle Antibacterial VPA22664/021/001 VPA22664/021/001 Norodine 240 mg/ml Solution for Injection Norbrook Laboratories (Ireland) Limited 01/10/1988 VM Unknown AU Solution for injection QJ01EW10 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Trimethoprim Sulfadiazine Prescription Only Medicine Cats Cattle Dogs Horses Pigs Antibacterial VPA22664/019/001 VPA22664/019/001 Norodine Equine Oral Paste Norbrook Laboratories (Ireland) Limited 01/10/1988 VM Unknown AU Oral paste QJ01EW10 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Trimethoprim Sulfadiazine Prescription Only Medicine Horses Antibacterial VPA22664/051/001 VPA22664/051/001 Noromectin 10 mg/ml Solution for Injection for Cattle and Pigs Norbrook Laboratories (Ireland) Limited 13/03/2000 VM Unknown AU Solution for injection QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Endectoparasiticides VPA22664/059/001 VPA22664/059/001 Noromectin 10 mg/ml Solution for Injection for sheep. Norbrook Laboratories (Ireland) Limited 29/06/2001 VM Unknown AU Solution for injection QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA22664/062/001 VPA22664/062/001 Noromectin 18.7 mg/g Oral Paste for Horses Norbrook Laboratories (Ireland) Limited 06/04/2001 VM Unknown AU Oral paste QP54AA01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Horses Endectoparasiticides VPA22664/052/001 VPA22664/052/001 Noromectin 5 mg/ml Pour-On Solution for Cattle Norbrook Laboratories (Ireland) Limited 13/03/2000 VM Unknown AU Pour-on solution QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA22664/053/001 VPA22664/053/001 Noromectin Drench 0.8 mg/ml Oral Solution for Sheep Norbrook Laboratories (Ireland) Limited 14/06/2000 VM Unknown AU Oral solution QP54AA01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA22664/068/001 VPA22664/068/001 Noromectin Multi Injection Solution for Injection Norbrook Laboratories (Ireland) Limited 22/02/2002 VM Unknown AU Solution for injection QP54AA01 Informed consent (abridged application) - Council Directive 81/851/EEC Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA22664/117/001 VPA22664/117/001 Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses Norbrook Laboratories (Ireland) Limited 27/09/2013 VM Unknown AU Oral paste QP54AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Ivermectin Praziquantel Prescription Only Medicine Horses Endectoparasiticides VPA22664/115/001 VPA22664/115/001 Noroseal 2.6 g Intramammary Suspension for Cattle Norbrook Laboratories (Ireland) Limited 26/07/2013 VM Marketed AU Intramammary suspension QG52X Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Bismuth subnitrate, heavy Licensed Retailer Cattle Miscellaneous VPA10660/005/001 VPA10660/005/001 Novaderma 660 mg/g + 7.7 mg/g cutaneous paste for horses, cattle and sheep WDT - Wirtschaftsgenossenschaft deutscher Tierarzte eG, 17/04/2026 VM Unknown AU Cutaneous paste QD02AF Hybrid application (Article 19(1) of Regulation (EU) 2019/6) Cutaneous use Salicylic acid Methyl salicylate Prescription Only Medicine Cattle Horses Sheep Miscellaneous VPA10463/006/001 VPA10463/006/001 Novamune concentrate and solvent for suspension for injection for chickens CEVA-Phylaxia Veterinary Biologicals Co. Ltd 31/08/2018 VM Unknown AU Concentrate and solvent for suspension for injection QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Avian infectious bursal disease virus, live Prescription Only Medicine Chickens Immunological VPA10420/003/001 VPA10420/003/001 Novocillin LC 1000 mg intramammary suspension for lactating cows Pharmanovo Veterinärarzneimittel GmbH 15/10/2021 VM Unknown AU Intramammary suspension QJ01CF04 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Oxacillin sodium Prescription Only Medicine Cattle Antibacterial VPA22931/001/001 VPA22931/001/001 Novomate 277.8 mg/ml powder and solvent for suspension for injection for cattle Lohmann Pharma Herstellung GmbH 04/12/2015 VM Marketed AU Powder and solvent for suspension for injection QJ01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Penethamate hydriodide Prescription Only Medicine Cattle Antibacterial VPA10782/048/001 VPA10782/048/001 Novosol 500 000 IU/g powder for use in drinking water/milk for cattle, chickens, pigs, ducks, turkeys, geese, quail and partridges Huvepharma NV 18/07/2025 VM Unknown AU Powder for use in drinking water/milk QA07AA01 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Neomycin sulfate Prescription Only Medicine Cattle Chickens Duck Goose Partridge Pigs Quail Turkeys Antibacterial VPA10996/268/001 VPA10996/268/001 NUFLOR 300 mg/ml solution for injection for cattle and sheep Intervet Ireland Limited 23/11/2012 VM Marketed AU Solution for injection QJ01BA90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Florfenicol Prescription Only Medicine Cattle Sheep Antibacterial VPA10996/207/001 VPA10996/207/001 Nuflor Minidose 450 mg/ml solution for injection for cattle Intervet Ireland Limited 12/09/2008 VM Marketed AU Solution for injection QJ01BA90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Florfenicol Prescription Only Medicine Cattle Antibacterial VPA22033/066/001 VPA22033/066/001 Nullamec 5 mg/ml pour-on solution for cattle Bimeda Animal Health Limited 14/06/2018 VM Unknown AU Pour-on solution QP54AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Endectoparasiticides VPA10516/026/001 VPA10516/026/001 Oapent 100 mg/ml Solution for injection for dogs Vetpharma Animal Health S.L. 05/06/2026 VM Unknown AU Solution for injection QM01AX90 Generic application (Article 18 of Regulation (EU) 2019/6) Subcutaneous use Pentosan Polysulfate Sodium Prescription Only Medicine Dogs Miscellaneous VPA10516/015/001 VPA10516/015/001 OCNIL 400 mg/g powder for use in drinking water Vetpharma Animal Health S.L. 28/07/2017 VM Unknown AU Powder for use in drinking water QJ01FF02 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Lincomycin Prescription Only Medicine Chickens Pigs Antibacterial VPA10989/051/001 VPA10989/051/001 Octacillin 697 mg/g powder for use in drinking water for chickens Eurovet Animal Health B.V. 21/12/2005 VM Unknown AU Powder for oral solution QJ01CA04 Not Currently Available Oral use Amoxicillin Prescription Only Medicine Chickens Antibacterial VPA10989/073/001 VPA10989/073/001 Octacillin 800 mg/g powder for use in drinking water for pigs Eurovet Animal Health B.V. 12/06/2020 VM Unknown AU Powder for use in drinking water QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Amoxicillin trihydrate Prescription Only Medicine Pigs Antibacterial VPA10521/003/001 VPA10521/003/001 Oestracton 52.4 microgram/ml solution for injection for cattle, horses, pigs Vetoquinol S.A. 08/11/2013 VM Unknown AU Solution for injection QH01CA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Gonadorelin (6-D-phenylalanine) acetate Prescription Only Medicine Cattle Horses Pigs Hormone VPA10892/001/001 VPA10892/001/001 Olab Sultrim 21% premix for medicated feed Old Castle Laboratories Limited 24/04/1995 VM Unknown AU Premix for medicated feeding stuff QJ01EW10 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Trimethoprim Sulfadiazine Prescription Only Medicine Pigs Antibacterial VPA10454/071/001 VPA10454/071/001 Omeproshield 370 mg/g oral paste for horses Boehringer Ingelheim Vetmedica GmbH 13/03/2015 VM Not marketed AU Oral paste QA02BC01 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Omeprazole Prescription Only Medicine Horses Alimentary Tract Preparation VPA23340/010/001 VPA23340/010/001 Ophtalon vet 10 mg/g eye ointment for dogs and cats Domes Pharma 26/06/2026 VM Unknown AU Eye ointment QS01AA01 Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6) Ocular use Chloramphenicol Prescription Only Medicine Cats Dogs Antibacterial VPA10475/028/001 VPA10475/028/001 Ophtocycline 10 mg/g eye ointment for dogs, cats and horses Le Vet Beheer B.V. 01/09/2017 VM Unknown AU Eye ointment QS01AA02 Generic application (Article 13(1) of Directive No 2001/82/EC) Ocular use Chlortetracycline hydrochloride Prescription Only Medicine Cats Dogs Horses Antibacterial VPA22664/007/001 VPA22664/007/001 Opticlox Eye Ointment 167 mg/g Norbrook Laboratories (Ireland) Limited 01/10/1987 VM Unknown AU Eye ointment QS01AA90 Full application (Article 12(3) of Directive No 2001/82/EC) Conjunctival use Ocular use Cloxacillin Prescription Only Medicine Cattle Horses Sheep Antibacterial VPA10996/242/001 VPA10996/242/001 Optimmune 2 mg/g Eye ointment for dogs Intervet Ireland Limited 19/04/2002 VM Unknown AU Eye ointment QS01XA90 QS01XA18 Full application (Article 12(3) of Directive No 2001/82/EC) Ocular use Ciclosporin Prescription Only Medicine Dogs Eye Preparation VPA22827/002/001 VPA22827/002/001 Optivar 500 mg beehive strips for honey bees Veto-Pharma 17/04/2026 VM Unknown AU Bee-hive strip QP53AD01 Bibliographic application (Article 22 of Regulation (EU) 2019/6) In-hive use Amitraz Licensed Retailer Honey bees Ectoparasiticide VPA10988/114/001 VPA10988/114/001 Optomease Vet 200 mg/ml concentrate for solution for fish treatment Virbac 12/06/2020 VM Unknown AU Concentrate for solution for fish treatment QN01AX92 Generic application (Article 13(1) of Directive No 2001/82/EC) Water-borne use Benzocaine Prescription Only Medicine Atlantic salmon Trout Neurological Preparations VPA10555/003/002 VPA10555/003/002 Orafluke 10 % w/v Oral Suspension Interchem Ireland Ltd 18/04/2008 VM Unknown AU Oral suspension QP52AC13 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Fenbendazole Rafoxanide Prescription Only Medicine Cattle Endoparasiticide VPA10555/003/001 VPA10555/003/001 Orafluke 5 % w/v Oral Suspension Interchem Ireland Ltd 18/04/2008 VM Unknown AU Oral suspension QP52AC13 QP52AG05 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Fenbendazole Rafoxanide Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10454/072/001 VPA10454/072/001 ORAMEC Drench for Sheep 0.8 mg/ml Boehringer Ingelheim Vetmedica GmbH 01/10/1994 VM Unknown AU Oral solution QP54AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA10484/012/001 VPA10484/012/001 Orazole 100 mg/ml Oral Drench Foran Healthcare Unlimited Company 13/08/1991 VM Unknown AU Oral suspension QP52AC13 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Fenbendazole Prescription Only Medicine Cattle Endoparasiticide VPA10387/045/001 VPA10387/045/001 Orbenin Dry Cow 500 mg Intramammary Suspension Zoetis Belgium S.A. 01/10/1997 VM Unknown AU Intramammary suspension QJ51CF02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use Cloxacillin Benzathine Prescription Only Medicine Cattle Antibacterial VPA10387/046/001 VPA10387/046/001 Orbenin Extra Dry Cow 600 mg intramammary suspension Zoetis Belgium S.A. 02/05/2014 VM Unknown AU Intramammary suspension QJ51CF02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use Cloxacillin Benzathine Prescription Only Medicine Cattle Antibacterial VPA10521/026/001 VPA10521/026/001 Oridermyl ear gel Vetoquinol S.A. 13/06/2008 VM Unknown AU Gel QS02CA04 Full application (Article 12(3) of Directive No 2001/82/EC) Auricular use Neomycin sulphate Nystatin Triamcinolone acetonide Permethrin (25:75) technical Prescription Only Medicine Dogs Antibacterial VPA10442/001/001 VPA10442/001/001 Orniflox 25 mg/ml concentrate for oral solution for pet rabbits, rodents, ornamental birds and reptiles Avimedical B.V. 27/11/2015 VM Unknown AU Oral solution QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Enrofloxacin Prescription Only Medicine Chinchilla Gerbil Guinea pig Hamster Mouse Ornamental birds Rat Reptiles Rabbit (non-food-producing) Antibacterial VPA22622/016/001 VPA22622/016/001 Osphos 51 mg/ml solution for injection for horses Dechra Regulatory B.V. 03/09/2015 VM Unknown AU Solution for injection QM05BA02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Clodronate disodium tetrahydrate Prescription Only Medicine Horses Miscellaneous VPA10987/131/001 VPA10987/131/001 Osteopen 100 mg/ml Solution for injection for dogs Chanelle Pharmaceuticals Manufacturing Limited 20/07/2018 VM Unknown AU Solution for injection QM01AX90 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Pentosan Polysulfate Sodium Prescription Only Medicine Dogs Miscellaneous VPA10987/168/001 VPA10987/168/001 Otisur Chanelle Pharmaceuticals Manufacturing Limited 23/02/2023 VM Unknown AU Ear drops, suspension QS02CA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Auricular use Cutaneous use Miconazole nitrate Prednisolone acetate Polymyxin b sulfate Prescription Only Medicine Cats Dogs Antibacterial VPA10996/244/001 VPA10996/244/001 Otomax Ear Drops Suspension Intervet Ireland Limited 07/09/2012 VM Unknown AU Ear drops, suspension QS02CA90 Fixed combination application (Article 13b of Directive No 2001/82/EC) Auricular use Gentamicin Betamethasone Clotrimazole Prescription Only Medicine Dogs Antibacterial VPA10774/077/001 VPA10774/077/001 Otomicol ear drops and cutaneous suspension for dogs, cats and guinea pigs Krka, d.d., Novo mesto 10/05/2024 VM Unknown AU Ear drops, suspension QS02CA01 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Auricular use Cutaneous use Miconazole nitrate Prednisolone acetate Polymyxin B sulfate Prescription Only Medicine Cats Dogs Guinea pig Antibacterial VPA10774/047/001 VPA10774/047/001 Otoxolan ear drops, suspension for dogs Krka, d.d., Novo mesto 20/01/2017 VM Unknown AU Ear drops, suspension QS02CA06 Generic application (Article 13(1) of Directive No 2001/82/EC) Auricular use Marbofloxacin Clotrimazole Dexamethasone acetate Prescription Only Medicine Dogs Antibacterial VPA10815/004/001 VPA10815/004/001 Ovarelin 50 ug/ml, solution for injection for cattle Ceva Santé Animale 07/12/2007 VM Unknown AU Solution for injection QH01CA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Gonadorelin Diacetate Tetrahydrate Prescription Only Medicine Cattle Hormone VPA10988/081/002 VPA10988/081/002 Ovarid Tablets 20 mg Virbac 01/10/1997 VM Unknown AU Tablet QG03AC05 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Megestrol acetate Prescription Only Medicine Cats Dogs Hormone VPA10988/081/001 VPA10988/081/001 Ovarid Tablets 5 mg Virbac 01/10/1997 VM Unknown AU Tablet QG03AC05 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Megestrol acetate Prescription Only Medicine Cats Dogs Hormone VPA10915/012/001 VPA10915/012/001 Ovimec 0.8 mg/ml Oral Solution for Sheep Ancare Ireland Ltd. 03/06/2005 VM Unknown AU Oral solution QP54AA02 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Abamectin Prescription Only Medicine Sheep Endectoparasiticides VPA22033/067/001 VPA22033/067/001 Ovimectin 10 mg/ml Solution for Injection for Sheep Bimeda Animal Health Limited 26/05/2006 VM Temporarily Not Marketed AU Solution for injection QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA10516/027/001 VPA10516/027/001 Ovimel 18 mg implantation tablets for sheep Vetpharma Animal Health S.L. 16/05/2025 VM Unknown AU Implantation tablet QN05CH01 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Subcutaneous use Melatonin Prescription Only Medicine Sheep Hormone VPA22033/078/001 VPA22033/078/001 Ovisect 12.5 mg/ml Pour-On Solution for Sheep Bimeda Animal Health Limited 04/07/2013 VM Unknown AU Pour-on solution QP53AC08 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Cypermethrin technical high-cis (80:20) Prescription Only Medicine Sheep Ectoparasiticide VPA10996/149/001 VPA10996/149/001 OVIVAC P PLUS Intervet Ireland Limited 21/03/2003 VM Unknown AU Suspension for injection QI04AB05 Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC) Subcutaneous use Clostridium perfringens type d, strain 603 epsilon toxoid Clostridium septicum s1110/85 toxoid Clostridium chauvoei strain no. 655 Clostridium chauvoei strain no. 656 Clostridium chauvoei strain no. 657 Clostridium chauvoei strain no. 658 Clostridium chauvoei strain no. 1048 Mannheimia haemolytica, serotype A1, strain S1006/77, Inactivated Mannheimia haemolytica, serotype A2, strain S1126/92, Inactivated Mannheimia haemolytica, serotype A6, strain S1084/81, Inactivated Formalin killed cells of mannheimia haemolytica serotypes a7 Mannheimia haemolytica, serotype A9, strain S994/77, Inactivated Formalin killed cells of pasteurella trehalosi serotypes t3 Bibersteinia trehalosi, serotype T4, strain S1085/81, Inactivated Bibersteinia trehalosi, serotype T10, strain S1075/81, Inactivated Formalin pasteurella trehalosi strain t15 (s1105/84) Clostridium tetani strain no. s1123/91 Licensed Retailer Sheep Immunological - Inactivated Vaccine VPA22028/007/001 VPA22028/007/001 OVIVERM 25 mg/ml Oral Suspension for Sheep Bioveta, a.s. 11/07/2025 VM Unknown AU Oral suspension QP52AA01 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Praziquantel Prescription Only Medicine Sheep Endoparasiticide VPA10915/001/001 VPA10915/001/001 Oxfencare Oral Suspension Ancare Ireland Ltd. 09/06/1992 VM Unknown AU Oral suspension QP52AC02 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Oxfendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10836/010/001 VPA10836/010/001 OXTRA DD 100 mg/ml solution for injection for cattle, sheep, pigs, horses, dogs and cats FATRO S.p.A. 18/09/2020 VM Marketed AU Solution for injection QJ01AA06 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Oxytetracycline hydrochloride Prescription Only Medicine Cats Cattle Dogs Horses Pigs Sheep Antibacterial VPA22033/042/001 VPA22033/042/001 Oxycomplex NS Solution for Injection Bimeda Animal Health Limited 10/06/1994 VM Unknown AU Solution for injection QJ01AA56 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Intravenous use Flunixin meglumine Oxytetracycline hydrochloride Prescription Only Medicine Cattle Antibacterial VPA22664/141/001 VPA22664/141/001 Oxyfluke 34 mg/ml Oral Suspension for Cattle and Sheep Norbrook Laboratories (Ireland) Limited 26/09/2017 VM Unknown AU Oral suspension QP52AG06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Oxyclozanide Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10981/005/001 VPA10981/005/001 Oxytetracycline 200 mg/ml L.A. solution for injection for cattle Kela n.v. 01/10/1988 VM Unknown AU Solution for injection QJ01AA06 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Oxytetracycline hydrochloride Prescription Only Medicine Cattle Antibacterial VPA10980/001/001 VPA10980/001/001 Oxytetracycline Injection 10% Alfasan Nederland B.V. 01/10/1988 VM Unknown AU Solution for injection QJ01AA06 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Oxytetracycline hydrochloride Prescription Only Medicine Cattle Antibacterial VPA10445/001/001 VPA10445/001/001 Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats Bela-Pharm GmbH & Co. KG 21/02/2014 VM Unknown AU Solution for injection QH01BB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Oxytocin Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Sheep Hormone VPA10826/004/001 VPA10826/004/001 Oxytocin aniMedica, solution for injection aniMedica GmbH 01/10/1999 VM Marketed AU Solution for injection QH01BB02 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Oxytocin Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Sheep Hormone VPA10989/044/001 VPA10989/044/001 Oxytocin Solution for Injection Eurovet Animal Health B.V. 01/10/1990 VM Unknown AU Solution for injection QH01BB02 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Intravenous use Oxytocin synthetic Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Sheep Hormone VPA10996/111/001 VPA10996/111/001 Panacur 100 mg/ml oral suspension for cattle and horses Intervet Ireland Limited 01/10/1999 VM Unknown AU Oral suspension QP52AC13 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Fenbendazole Prescription Only Medicine Cattle Horses Endoparasiticide VPA10996/118/001 VPA10996/118/001 Panacur Equine 187.5 mg/g Oral Paste Intervet Ireland Limited 01/10/1999 VM Unknown AU Oral paste QP52AC13 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Fenbendazole Prescription Only Medicine Horses Endoparasiticide VPA10996/188/001 VPA10996/188/001 Panacur PetPaste 187.5 mg/g oral paste for dogs and cats Intervet Ireland Limited 23/09/2005 VM Not marketed AU Oral paste QP52AC13 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Fenbendazole Prescription Only Medicine Cats Dogs Endoparasiticide VPA10454/073/001 VPA10454/073/001 Panomec 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Boehringer Ingelheim Vetmedica GmbH 19/12/1995 VM Not marketed AU Solution for injection QP54AA01 Veterinary medicinal products intended for animals exclusively kept as pets (article 5(6) of Reg 2019/6) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA10996/215/001 VPA10996/215/001 Paracox-5, suspension for oral suspension for chickens Intervet Ireland Limited 23/07/2010 VM Unknown AU Suspension for oral suspension QI01AN01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Eimeria acervulina hp Eimeria maxima cp Eimeria maxima mfp Eimeria mitis hp Eimeria tenella hp Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10996/245/001 VPA10996/245/001 Paracox-8, suspension for oral suspension for chickens Intervet Ireland Limited 19/10/2007 VM Unknown AU Suspension for oral suspension QI01AN01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Eimeria acervulina hp Eimeria brunetti hp Eimeria maxima cp Eimeria maxima mfp Eimeria mitis hp Eimeria necatrix hp Eimeria praecox hp Eimeria tenella hp Prescription Only Medicine Chickens Immunological - Live Vaccine VPA22664/040/001 VPA22664/040/001 Parafend 2.265 % Oral Suspension Norbrook Laboratories (Ireland) Limited 10/02/1994 VM Unknown AU Oral suspension QP52AC02 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Oxfendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA22664/070/001 VPA22664/070/001 Parafend Plus Oral Suspension Norbrook Laboratories (Ireland) Limited 30/06/2003 VM Unknown AU Oral suspension QP52AC52 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Oxfendazole Closantel Prescription Only Medicine Sheep Endoparasiticide VPA22664/061/001 VPA22664/061/001 Paramectin 0.8 mg/ml Drench for Sheep Norbrook Laboratories (Ireland) Limited 12/01/2001 VM Unknown AU Oral suspension QP54AA01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA22664/065/001 VPA22664/065/001 Paramectin 10 mg/ml Solution for Injection Norbrook Laboratories (Ireland) Limited 29/06/2001 VM Unknown AU Solution for injection QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Endectoparasiticides VPA22664/066/001 VPA22664/066/001 Paramectin 5 mg/ml Pour-On Solution for cattle Norbrook Laboratories (Ireland) Limited 29/06/2001 VM Unknown AU Pour-on solution QP54AA01 Informed consent (abridged application) - Council Directive 81/851/EEC Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10484/021/001 VPA10484/021/001 Parazole 10% w/v Oral Suspension Foran Healthcare Unlimited Company 01/10/1997 VM Unknown AU Oral suspension QP52AC13 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Fenbendazole Companion Animal Medicine Cats Dogs Endoparasiticide VPA10484/022/001 VPA10484/022/001 Parazole Dog/Cat 100 mg/ml Oral Suspension Foran Healthcare Unlimited Company 21/09/2018 VM Marketed AU Oral suspension QP52AC13 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Fenbendazole Companion Animal Medicine Cats Dogs Endoparasiticide VPA10782/026/001 VPA10782/026/001 Parofor 140 mg/ml solution for use in drinking water/milk for cattle (pre-ruminant) and pigs Huvepharma NV 04/08/2017 VM Unknown AU Oral solution QA07AA06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Paromomycin Prescription Only Medicine Cattle Pigs Antibacterial VPA10782/014/001 VPA10782/014/001 Parofor 70000 IU/g powder for use in drinking water/ milk for cattle (pre-ruminant) and pigs. Huvepharma NV 12/09/2014 VM Marketed AU Powder for use in drinking water QA07AA06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Paromomycin Prescription Only Medicine Cattle Pigs Antibacterial VPA10782/035/001 VPA10782/035/001 Parofor crypto 140 000 IU/ml oral solution for pre-ruminant cattle Huvepharma NV 07/06/2019 VM Unknown AU Oral solution QA07AA06 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Paromomycin Prescription Only Medicine Cattle Antibacterial VPA10782/033/001 VPA10782/033/001 Parofor crypto 140 000 IU/ml oral solution for sheep and goats Huvepharma NV 05/07/2019 VM AU Oral solution QA07AA06 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Paromomycin sulfate Prescription Only Medicine Goats Sheep Antibacterial VPA10815/052/001 VPA10815/052/001 Parvoruvax suspension for injection for pigs Ceva Santé Animale 01/05/2002 VM Unknown AU Suspension for injection QI09AL01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Porcine parvovirus inactivated k-22 strain Erysipelothrix rhusiopathiae, serotype 2, Inactivated Licensed Retailer Pigs Immunological - Inactivated Vaccine VPA10823/002/001 VPA10823/002/001 PEN/STREP Injection Chem-Pharm Limited 01/10/1997 VM Unknown AU Suspension for injection QJ01RA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Procaine benzylpenicillin Dihydrostreptomycin sulfate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22664/009/001 VPA22664/009/001 Pen & Strep Suspension for Injection Norbrook Laboratories (Ireland) Limited 01/10/1987 VM Unknown AU Suspension for injection QJ01RA01 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Procaine benzylpenicillin Dihydrostreptomycin sulfate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10980/009/001 VPA10980/009/001 Pen-Strep 20/20 Suspension for Injection Alfasan Nederland B.V. 01/10/1987 VM Unknown AU Suspension for injection QJ01RA01 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Procaine benzylpenicillin Streptomycin sulphate Procaine hydrochloride Prescription Only Medicine Cattle Antibacterial VPA10505/004/001 VPA10505/004/001 Penethaone 236.3 mg/ml powder and solvent for suspension for injection for cattle Divasa-Farmavic S.A., 03/09/2015 VM Unknown AU Powder and solvent for suspension for injection QJ01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Penethamate hydriodide Penethamate hydriodide Penethamate hydriodide Prescription Only Medicine Cattle Antibacterial VPA10990/005/001 VPA10990/005/001 Pentomycin Suspension for Injection for Cattle, Sheep and Pigs Univet Limited 01/10/1987 VM Unknown AU Suspension for injection QJ01RA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Benzylpenicillin procaine Dihydrostreptomycin sulphate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22664/149/001 VPA22664/149/001 Peptaleve 370 mg/g Oral Paste for Horses Norbrook Laboratories (Ireland) Limited 29/05/2020 VM Unknown AU Oral paste QA02BC01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Omeprazole Prescription Only Medicine Horses Alimentary Tract Preparation VPA22664/113/001 VPA22664/113/001 Peptizole 370 mg/g Oral Paste for Horses Norbrook Laboratories (Ireland) Limited 26/07/2013 VM Unknown AU Oral paste QA02BC01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Omeprazole Prescription Only Medicine Horses Alimentary Tract Preparation VPA10782/049/001 VPA10782/049/001 Pereprin 5 mg/ml pour on solution for cattle, sheep and goats Huvepharma NV 30/01/2026 VM Unknown AU Pour-on solution QP54AA04 Generic application (Article 18 of Regulation (EU) 2019/6) Pour-on use Eprinomectin Prescription Only Medicine Cattle Goats Sheep Endectoparasiticides VPA10980/042/004 VPA10980/042/004 Pergocoat 0.25 mg film-coated tablets for horses Alfasan Nederland B.V. 28/10/2025 VM Unknown AU Film-coated tablet QN04BC02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Pergolide mesilate Prescription Only Medicine Horse (non-food producing) Neurological Preparations VPA10980/042/001 VPA10980/042/001 Pergocoat 0.5 mg film-coated tablets for horses Alfasan Nederland B.V. 18/08/2023 VM Unknown AU Film-coated tablet QN04BC02 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Pergolide mesilate Prescription Only Medicine Horses Neurological Preparations VPA10980/042/002 VPA10980/042/002 Pergocoat 1 mg film-coated tablets for horses Alfasan Nederland B.V. 18/08/2023 VM Unknown AU Film-coated tablet QN04BC02 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Pergolide mesilate Prescription Only Medicine Horses Neurological Preparations VPA10980/042/003 VPA10980/042/003 Pergocoat 2 mg film-coated tablets for horses Alfasan Nederland B.V. 18/08/2023 VM Unknown AU Film-coated tablet QN04BC02 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Pergolide mesilate Prescription Only Medicine Horses Neurological Preparations VPA23462/014/001 VPA23462/014/001 Pergoquin 1 mg tablets for horses VetViva Richter GmbH 21/10/2022 VM Unknown AU Tablet QN04BC02 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Pergolide Prescription Only Medicine Horses Neurological Preparations VPA10505/005/001 VPA10505/005/001 Permacyl 236.3 mg/ml powder and solvent for suspension for injection for cattle Divasa-Farmavic S.A., 09/10/2015 VM Unknown AU Powder and solvent for suspension for injection QJ01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Penethamate hydriodide Penethamate hydriodide Penethamate hydriodide Prescription Only Medicine Cattle Antibacterial VPA10983/062/001 VPA10983/062/001 PERMAWAY 600 mg intramammary suspension for cattle Vetoquinol Ireland Limited 23/04/2021 VM Unknown AU Intramammary suspension QJ51CF02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Cloxacillin Benzathine Prescription Only Medicine Cattle Antibacterial VPA22664/095/002 VPA22664/095/002 Pestigon 134 mg Spot-On Solution for Medium Dogs Norbrook Laboratories (Ireland) Limited 06/07/2012 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/095/003 VPA22664/095/003 Pestigon 268 mg Spot-On Solution for large dogs Norbrook Laboratories (Ireland) Limited 06/07/2012 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/095/004 VPA22664/095/004 Pestigon 402 mg Spot-On Solution for very large dogs Norbrook Laboratories (Ireland) Limited 06/07/2012 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/098/001 VPA22664/098/001 Pestigon 50 mg Spot-On Solution for Cats Norbrook Laboratories (Ireland) Limited 06/07/2012 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Cats Ectoparasiticide VPA22664/095/001 VPA22664/095/001 Pestigon 67 mg Spot-On Solution for Small Dogs Norbrook Laboratories (Ireland) Limited 06/07/2012 VM Unknown AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA22664/135/002 VPA22664/135/002 PestiGon Combo 134 mg/120.6 mg spot-on solution for medium dogs Norbrook Laboratories (Ireland) Limited 12/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA22664/135/003 VPA22664/135/003 PestiGon Combo 268 mg/241.2 mg spot-on solution for large dogs Norbrook Laboratories (Ireland) Limited 12/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA22664/135/004 VPA22664/135/004 PestiGon Combo 402 mg/361.8 mg spot-on solution for very large dogs Norbrook Laboratories (Ireland) Limited 12/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA22664/131/001 VPA22664/131/001 PestiGon Combo 50 mg/60 mg spot-on solution for cats and ferrets Norbrook Laboratories (Ireland) Limited 12/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Cats Ferrets Ectoparasiticide VPA22664/135/001 VPA22664/135/001 PestiGon Combo 67 mg/60.3 mg spot-on solution for small dogs Norbrook Laboratories (Ireland) Limited 12/05/2017 VM Unknown AU Spot-on solution QP53AX65 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10996/025/001 VPA10996/025/001 PG 600 Powder and solvent for solution for injection Intervet Ireland Limited 01/10/1989 VM Unknown AU Powder and solvent for solution for injection QG03GA99 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Gonadotrophin equine serum Gonadotrophin chorionic Prescription Only Medicine Pigs Hormone VPA10539/002/001 VPA10539/002/001 PGF Veyx 0.0875 mg/ml solution for injection for cattle and pigs Veyx-Pharma GmbH 19/10/2012 VM Unknown AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cloprostenol sodium Prescription Only Medicine Cattle Pigs Hormone VPA10539/002/002 VPA10539/002/002 PGF Veyx forte 0.250 mg/ml solution for injection for cattle and pigs Veyx-Pharma GmbH 19/10/2012 VM Unknown AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cloprostenol sodium Prescription Only Medicine Cattle Pigs Hormone VPA10782/012/001 VPA10782/012/001 Pharmasin 1 g/g Granules for Use in Drinking Water for Pigs, Chickens, Turkeys and Calves Huvepharma NV 08/04/2011 VM Unknown AU Granules for use in drinking water QJ01FA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Tylosin tartrate Prescription Only Medicine Cattle Chickens Pigs Turkeys Antibacterial VPA10782/006/002 VPA10782/006/002 Pharmasin 100 000 IU/g Premix for medicated feeding stuff for pigs, broilers and pullets Huvepharma NV 21/08/2009 VM Unknown AU Premix for medicated feeding stuff QJ01FA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Tylosin Prescription Only Medicine Chickens Pigs Antibacterial VPA10782/001/002 VPA10782/001/002 Pharmasin 20 000 IU/g Oral Granules for pigs Huvepharma NV 21/08/2009 VM Unknown AU Granules QJ01FA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Tylosin Prescription Only Medicine Pigs Antibacterial VPA10782/015/001 VPA10782/015/001 Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs Huvepharma NV 07/06/2013 VM Unknown AU Solution for injection QJ01FA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Tylosin Prescription Only Medicine Cattle Goats Pigs Sheep Antibacterial VPA10782/006/003 VPA10782/006/003 Pharmasin 250 000 IU/g Premix for medicated feeding stuff for pigs, broilers and pullets Huvepharma NV 21/08/2009 VM Unknown AU Premix for medicated feeding stuff QJ01FA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Tylosin (base) Prescription Only Medicine Chickens Pigs Antibacterial VPA10989/065/001 VPA10989/065/001 Phenocillin 800 mg/g powder for use in drinking water for chickens Eurovet Animal Health B.V. 22/01/2016 VM Unknown AU Powder for use in drinking water QJ01CE02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Phenoxymethylpenicillin potassium Prescription Only Medicine Chickens Antibacterial VPA10980/044/002 VPA10980/044/002 Phenocoat 12.5 mg film-coated tablets for dogs Alfasan Nederland B.V. 11/10/2024 VM Unknown AU Film-coated tablet QN03AA02 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10980/044/003 VPA10980/044/003 Phenocoat 25 mg film-coated tablets for dogs Alfasan Nederland B.V. 11/10/2024 VM Unknown AU Film-coated tablet QN03AA02 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10980/044/001 VPA10980/044/001 Phenocoat 5 mg film-coated tablets for dogs Alfasan Nederland B.V. 11/10/2024 VM Unknown AU Film-coated tablet QN03AA02 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10980/044/004 VPA10980/044/004 Phenocoat 50 mg film-coated tablets for dogs Alfasan Nederland B.V. 11/10/2024 VM Unknown AU Film-coated tablet QN03AA02 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA22622/045/004 VPA22622/045/004 Phenoleptil 100 mg Tablets for dogs Dechra Regulatory B.V. 15/02/2013 VM Unknown AU Tablet QN03AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA22622/045/001 VPA22622/045/001 Phenoleptil 12.5 mg tablets for dogs Dechra Regulatory B.V. 17/06/2011 VM Unknown AU Tablet QN03AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA22622/045/003 VPA22622/045/003 Phenoleptil 25 mg Tablets for dogs Dechra Regulatory B.V. 15/02/2013 VM Unknown AU Tablet QN03AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA22622/045/002 VPA22622/045/002 Phenoleptil 50 mg tablets for dogs Dechra Regulatory B.V. 17/06/2011 VM Unknown AU Tablet QN03AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10980/043/003 VPA10980/043/003 Phenosan 100 mg chewable tablets for dogs Alfasan Nederland B.V. 11/10/2024 VM Unknown AU Chewable tablet QN03AA02 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10980/043/001 VPA10980/043/001 Phenosan 12.5 mg chewable tablets for dogs Alfasan Nederland B.V. 11/10/2024 VM Unknown AU Chewable tablet QN03AA02 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10980/043/002 VPA10980/043/002 Phenosan 50 mg chewable tablets for dogs Alfasan Nederland B.V. 11/10/2024 VM Unknown AU Chewable tablet QN03AA02 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10810/019/003 VPA10810/019/003 Phenotab Flavoured 100 mg Tablets for dogs CP-Pharma Handelsgesellschaft mbH 11/09/2020 VM Unknown AU Tablet QN03AA02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10810/019/001 VPA10810/019/001 Phenotab Flavoured 25 mg Tablets for dogs CP-Pharma Handelsgesellschaft mbH 11/09/2020 VM Unknown AU Tablet QN03AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10810/019/002 VPA10810/019/002 Phenotab Flavoured 60 mg Tablets for dogs CP-Pharma Handelsgesellschaft mbH 11/09/2020 VM Unknown AU Tablet QN03AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Phenobarbital Prescription Only Medicine Dogs Neurological Preparations VPA10791/001/001 VPA10791/001/001 Phenoxypen Water Soluble Powder, 325 mg/g powder for use in drinking water for pigs and chickens Dopharma Research B.V. 25/10/2006 VM Marketed AU Powder for oral solution QJ01CE02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Phenoxymethylpenicillin Prescription Only Medicine Chickens Pigs Antibacterial VPA10521/020/001 VPA10521/020/001 Phenylarthrite solution for injection Vetoquinol S.A. 01/10/1989 VM Unknown AU Solution for injection QM01AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Phenylbutazone Prescription Only Medicine Dogs Horse (non-food producing) N.S.A.I.D. VPA10782/029/001 VPA10782/029/001 Pigfen 200 mg/ml suspension for use in drinking water for pigs Huvepharma NV 29/03/2018 VM Unknown AU Suspension for use in drinking water QP52AC13 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Fenbendazole Prescription Only Medicine Pigs Endoparasiticide VPA10782/019/001 VPA10782/019/001 Pigfen 40 mg/g granules for pigs Huvepharma NV 11/09/2015 VM Unknown AU Granules QP52AC13 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Fenbendazole Prescription Only Medicine Pigs Endoparasiticide VPA10782/021/001 VPA10782/021/001 Pigfen 40 mg/g premix for medicated feeding stuff for pigs Huvepharma NV 09/12/2016 VM Unknown AU Premix for medicated feeding stuff QP52AC13 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In-feed use Fenbendazole Prescription Only Medicine Pigs Endoparasiticide VPA10989/067/001 VPA10989/067/001 Pimocard 1.25 mg flavoured tablets for dogs Eurovet Animal Health B.V. 22/01/2016 VM Not marketed AU Tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10989/067/004 VPA10989/067/004 Pimocard 10 mg flavoured tablets for dogs Eurovet Animal Health B.V. 22/01/2016 VM Not marketed AU Tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10989/067/002 VPA10989/067/002 Pimocard 2.5 mg flavoured tablets for dogs Eurovet Animal Health B.V. 22/01/2016 VM Not marketed AU Tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10989/067/003 VPA10989/067/003 Pimocard 5 mg flavoured tablets for dogs Eurovet Animal Health B.V. 22/01/2016 VM Not marketed AU Tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA22664/153/001 VPA22664/153/001 Pimodine 5 mg/ml Oral Suspension for Dogs Norbrook Laboratories (Ireland) Limited 24/07/2026 VM Unknown AU Oral suspension QC01CE90 Hybrid application – change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10810/018/001 VPA10810/018/001 Pimotab 1.25 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 17/07/2020 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10810/018/004 VPA10810/018/004 Pimotab 10 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 17/07/2020 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10810/018/005 VPA10810/018/005 Pimotab 15 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 17/07/2020 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10810/018/002 VPA10810/018/002 Pimotab 2.5 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 17/07/2020 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10810/018/003 VPA10810/018/003 Pimotab 5 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 17/07/2020 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10790/014/001 VPA10790/014/001 PIRESOL 300 mg/ml solution for use in drinking water for pigs SP Veterinaria, S.A. 02/08/2019 VM AU Solution for use in drinking water QN02BE01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Paracetamol Prescription Only Medicine Pigs Miscellaneous VPA10996/246/001 VPA10996/246/001 Planate 87.5 micrograms/ml, solution for injection Intervet Ireland Limited 01/10/1991 VM Unknown AU Solution for injection QG02AD90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Cloprostenol Prescription Only Medicine Pigs Hormone VPA10454/017/001 VPA10454/017/001 Planipart Solution for Injection 30 microgram/ml Boehringer Ingelheim Vetmedica GmbH 01/10/1989 VM Unknown AU Solution for injection QG02CA91 Full application (Article 12(3) of Directive No 2001/82/EC) Intravenous use Clenbuterol hydrochloride Prescription Only Medicine Cattle Miscellaneous VPA10665/001/001 VPA10665/001/001 Pluset 500 IU/ml + 500 IU/ml powder and solvent for solution for injection for cattle LABORATORIOS CALIER S.A. 26/09/2008 VM Marketed AU Powder and solvent for solution for injection QG03GA Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Follicle stimulating hormone (fshp) Luteinizing hormone (lhp) Follicle stimulating hormone (fshp) Luteinizing hormone (lhp) Prescription Only Medicine Cattle Hormone VPA22715/002/001 VPA22715/002/001 Pneumovac Plus suspension for injection for cattle Animal Health Distributors Limited 08/01/2021 VM Unknown AU Suspension for injection QI02AL04 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Bovine respiratory syncytial virus, strain bio-24, inactivated Bovine parainfluenza 3 virus, strain bio-23, inactivated Mannheimia Haemolytica, serotype A1 strain dsm 5283, inactivated Bovine Viral Diarrhoea Virus, Strain Bio-25, Inactavited Prescription Only Exempt Cattle Immunological - Inactivated Vaccine VPA22715/001/001 VPA22715/001/001 Pneumovac suspension for injection for cattle Animal Health Distributors Limited 08/01/2021 VM Unknown AU Suspension for injection QI02AL04 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Bovine Respiratory Syncytial Virus, Strain Bio-24 Inactivated Bovine parainfluenza 3 virus, strain bio-23, inactivated Mannheimia Haemolytica, serotype A1 strain dsm 5283, inactivated Prescription Only Exempt Cattle Immunological VPA10996/100/001 VPA10996/100/001 Porcilis APP suspension for injection for pigs Intervet Ireland Limited 31/01/2014 VM Unknown AU Suspension for injection QI09AB07 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Concentrate of actinobacillus pleuropneumoniae antigens containing Omp (outer membrane protein) Apxi (105 kilodalton type i toxoid) Apxii (105 kilodalton type ii toxoid) Apxiii (120 kilodalton macrophage toxoid) Prescription Only Exempt Pigs Immunological - Inactivated Vaccine VPA10996/097/001 VPA10996/097/001 Porcilis Ery + Parvo suspension for injection for pigs Intervet Ireland Limited 04/05/2001 VM Unknown AU Suspension for injection QI09AL01 Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC) Intramuscular use Inactivated porcine parvovirus strain 014 Inactivated erysipelothrix rhusiopathiae strain M2 (Serotype 2) Licensed Retailer Pigs Immunological - Inactivated Vaccine VPA10996/096/001 VPA10996/096/001 Porcilis ERY suspension for injection for pigs Intervet Ireland Limited 10/04/2001 VM Unknown AU Suspension for injection QI09AB Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Erysipelothrix rhusiopathiae strain m2 (serotype 2) Licensed Retailer Pigs Immunological - Inactivated Vaccine VPA10996/279/001 VPA10996/279/001 Porcilis Ery+Parvo+Lepto suspension for injection for pigs Intervet Ireland Limited 16/12/2016 VM Unknown AU Suspension for injection QI09AL07 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use E.rhusiopathiae strain m2 Porcine parvo virus Leptospira canicola Leptospira icterohaemorrhagiae Leptospira australis Leptospira grippotyphosa Leptospira pomona Leptospira tarassovi Licensed Retailer Pigs Immunological - Inactivated Vaccine VPA10996/179/001 VPA10996/179/001 Porcilis Glässer Intervet Ireland Limited 04/03/2004 VM Unknown AU Suspension for injection QI09AB07 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Haemophilus parasuis, serotype 5, strain 4800, Inactivated Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA10996/280/001 VPA10996/280/001 Porcilis Lawsonia ID lyophilisate and solvent for emulsion for injection for pigs Intervet Ireland Limited 08/01/2021 VM Unknown AU Lyophilisate and solvent for suspension for injection QI09AB Full application (Article 12(3) of Directive No 2001/82/EC) Intradermal use Lawsonia intracellularis strain spah-08 inactivated Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA10996/278/001 VPA10996/278/001 Porcilis Lawsonia lyophilisate and solvent for emulsion for injection for pigs Intervet Ireland Limited 08/11/2019 VM AU Lyophilisate and solvent for emulsion for injection QI09AB Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated Lawsonia intracellularis strain SPAH-08 Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA10996/264/001 VPA10996/264/001 Porcilis M Hyo ID ONCE emulsion for injection for pigs Intervet Ireland Limited 20/01/2012 VM Unknown AU Emulsion for injection QI09AB13 Full application (Article 12(3) of Directive No 2001/82/EC) Intradermal use Inactivated whole cell concentrate of m. hyopneumoniae strain 11 Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA10996/128/001 VPA10996/128/001 Porcilis PRRS lyophilisate and solvent for suspension for injection for pigs Intervet Ireland Limited 06/06/2003 VM Unknown AU Lyophilisate and solvent for suspension for injection QI09AD03 Full application (Article 12(3) of Directive No 2001/82/EC) Intradermal use Intramuscular use Porcine reproductive respiratory syndrome (prrs) virus strain dv live Prescription Only Medicine Pigs Immunological - Live Vaccine VPA10387/049/001 VPA10387/049/001 Poulvac Bursa Plus Lyophilisate for suspension in drinking water for chickens Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Lyophilisate for use in drinking water QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Live infectious bursal disease virus, strain V877 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10387/091/001 VPA10387/091/001 Poulvac Bursine 2 lyophilisate for suspension for spray vaccination or for use in drinking water for chickens Zoetis Belgium S.A. 18/09/2015 VM Unknown AU Lyophilisate for oculonasal suspension/use in drinking water QI01AD09 Full application (Article 12(3) of Directive No 2001/82/EC) Coarse spray In drinking water use Infectious bursal disease virus strain lukert Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10387/051/001 VPA10387/051/001 Poulvac IB QX lyophilisate for oculonasal suspension for chickens Zoetis Belgium S.A. 06/09/2013 VM Not marketed AU Lyophilisate for suspension for spray administration QI01AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Coarse spray Live attenuated avian infectious bronchitis virus strain L1148 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10387/053/001 VPA10387/053/001 POULVAC IBMM + ARK Lyophilisate for suspension for spray administration for chickens Zoetis Belgium S.A. 09/12/2013 VM Not marketed AU Lyophilisate for suspension for spray administration QI01AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Avian infectious bronchitis virus strain massachusetts 1263 Avian infectious bronchitis virus strain arkansas 3168 Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10454/011/001 VPA10454/011/001 Prascend 1 mg tablets for horses Boehringer Ingelheim Vetmedica GmbH 21/05/2010 VM Unknown AU Tablet QN04BC02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Pergolide Prescription Only Medicine Horse (non-food producing) Neurological Preparations VPA10810/030/001 VPA10810/030/001 Prasequine 1 mg tablets for horses CP-Pharma Handelsgesellschaft mbH 14/07/2023 VM Unknown AU Tablet QN04BC02 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Pergolide mesilate Prescription Only Medicine Horses Neurological Preparations VPA10987/101/001 VPA10987/101/001 Prazitel 230/20 mg Flavoured Film-Coated Tablets for Cats Chanelle Pharmaceuticals Manufacturing Limited 12/07/2013 VM Unknown AU Film-coated tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pyrantel embonate Praziquantel Companion Animal Medicine Cats Endoparasiticide VPA10987/076/001 VPA10987/076/001 Prazitel Plus Tablets for Dogs Chanelle Pharmaceuticals Manufacturing Limited 27/02/2009 VM Unknown AU Tablet QP52AA51 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10987/076/002 VPA10987/076/002 Prazitel Plus XL Tablets For Dogs Chanelle Pharmaceuticals Manufacturing Limited 02/03/2012 VM Unknown AU Tablet QP52AA01 QP52AC05 QP52AF02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA22622/038/002 VPA22622/038/002 Prednicortone 20 mg tablets for dogs and cats Dechra Regulatory B.V. 23/10/2015 VM Unknown AU Tablet QH02AB06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Prednisolone Prescription Only Medicine Cats Dogs Corticosteroid VPA22622/038/001 VPA22622/038/001 Prednicortone 5 mg tablets for dogs and cats Dechra Regulatory B.V. 23/10/2015 VM Unknown AU Tablet QH02AB06 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Prednisolone Prescription Only Medicine Cats Dogs Corticosteroid VPA25237/003/002 VPA25237/003/002 Preglukord 5 mg tablets for dogs and cats Accord Healthcare B.V. 16/01/2026 VM Unknown AU Tablet QH02AB06 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Prednisolone Prescription Only Medicine Cats Dogs Corticosteroid VPA25237/003/001 VPA25237/003/001 Preglukord 1 mg tablets for dogs and cats Accord Healthcare B.V. 16/01/2026 VM Unknown AU Tablet QH02AB06 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Prednisolone Prescription Only Medicine Cats Dogs Corticosteroid VPA25237/003/003 VPA25237/003/003 Preglukord 25 mg tablets for dogs Accord Healthcare B.V. 16/01/2026 VM Unknown AU Tablet QH02AB06 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Oral use Prednisolone Prescription Only Medicine Dogs Corticosteroid VPA10980/030/001 VPA10980/030/001 Presedine 10 mg/ml solution for injection for horses and cattle Alfasan Nederland B.V. 04/08/2023 VM Unknown AU Solution for injection QN05CM90 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Detomidine hydrochloride Prescription Only Medicine Cattle Horses Neurological Preparations VPA10815/013/001 VPA10815/013/001 Prid delta 1.55 g vaginal delivery system for cattle Ceva Santé Animale 10/12/2010 VM Not marketed AU Vaginal delivery system QG03DA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Vaginal use Progesterone Prescription Only Medicine Cattle Hormone VPA10483/001/001 VPA10483/001/001 PRID E 1.55 g vaginal delivery system for cattle LAPROVET 24/08/2012 VM Unknown AU Vaginal delivery system QG03DA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Vaginal use Progesterone Prescription Only Medicine Cattle Hormone VPA10815/035/001 VPA10815/035/001 Prilactone Next 10 mg chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QC03DA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Spironolactone Prescription Only Medicine Dogs Cardiovascular VPA10815/035/003 VPA10815/035/003 Prilactone Next 100 mg chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QC03DA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Spironolactone Prescription Only Medicine Dogs Cardiovascular VPA10815/035/002 VPA10815/035/002 Prilactone Next 50 mg chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QC03DA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Spironolactone Prescription Only Medicine Dogs Cardiovascular VPA22664/078/001 VPA22664/078/001 Primectin 5 mg/ml Pour-On Solution Norbrook Laboratories (Ireland) Limited 08/12/2000 VM Unknown AU Pour-on solution QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA22664/022/001 VPA22664/022/001 Primidoxine Solution for Injection Norbrook Laboratories (Ireland) Limited 01/10/1989 VM Unknown AU Solution for injection QJ01EW13 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Intravenous use Subcutaneous use Trimethoprim Sulfadoxine Prescription Only Medicine Cats Cattle Dogs Horses Pigs Antibacterial VPA10836/007/001 VPA10836/007/001 PRIMOPEN 300 mg/ml suspension for injection for cattle, pigs and horses FATRO S.p.A. 18/09/2020 VM Marketed AU Suspension for injection QJ01CE09 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Benzylpenicillin procaine monohydrate Prescription Only Medicine Cattle Horses Pigs Antibacterial VPA10665/009/001 VPA10665/009/001 Primun salmonella E Lyophilisate for use in drinking water for chickens LABORATORIOS CALIER S.A. 16/08/2024 VM Unknown AU Lyophilisate for use in drinking water QI01AE01 Full application (Article 8 of Regulation (EU) 2019/6) In drinking water use Salmonella enterica, subsp. enterica, serovar Enteritidis, strain CAL10 Sm+/Rif+/Ssq-, Live Prescription Only Medicine Chickens Immunological - Live Vaccine VPA10774/070/002 VPA10774/070/002 Prinocate 100 mg/25 mg spot-on solution for medium dogs Krka, d.d., Novo mesto 29/05/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/070/003 VPA10774/070/003 Prinocate 250 mg/62.5 mg spot-on solution for large dogs Krka, d.d., Novo mesto 29/05/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/070/001 VPA10774/070/001 Prinocate 40 mg/10 mg spot-on solution for small dogs Krka, d.d., Novo mesto 29/05/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/068/001 VPA10774/068/001 Prinocate 40 mg/4 mg spot-on solution for small cats and ferrets Krka, d.d., Novo mesto 29/05/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Cats Ferrets Endectoparasiticides VPA10774/070/004 VPA10774/070/004 Prinocate 400 mg/100 mg spot-on solution for extra-large dogs Krka, d.d., Novo mesto 29/05/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/069/001 VPA10774/069/001 Prinocate 80 mg/8 mg spot-on solution for large cats Krka, d.d., Novo mesto 29/05/2020 VM Unknown AU Spot-on solution QP54AB52 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Cats Endectoparasiticides VPA22020/057/002 VPA22020/057/002 Prinovox 100 mg + 25 mg spot-on solution for medium dogs Elanco GmbH 05/05/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA22020/057/003 VPA22020/057/003 Prinovox 250 mg + 62.5 mg spot-on solution for large dogs Elanco GmbH 05/05/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA22020/057/001 VPA22020/057/001 Prinovox 40 mg + 10 mg spot-on solution for small dogs. Elanco GmbH 05/05/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA22020/056/001 VPA22020/056/001 Prinovox 40 mg + 4 mg spot-on solution for small cats and ferrets Elanco GmbH 05/05/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Cats Ferrets Endectoparasiticides VPA22020/057/004 VPA22020/057/004 Prinovox 400 mg + 100 mg spot-on solution for extra-large dogs Elanco GmbH 05/05/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Dogs Endectoparasiticides VPA22020/056/002 VPA22020/056/002 Prinovox 80 mg + 8 mg spot-on solution for large cats Elanco GmbH 05/05/2017 VM Unknown AU Spot-on solution QP54AB52 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Imidacloprid Moxidectin Prescription Only Medicine Cats Endectoparasiticides VPA10555/007/001 VPA10555/007/001 Pro Penstrep Suspension for Injection for Cattle, Sheep and Pigs Interchem Ireland Ltd 10/02/2012 VM Unknown AU Suspension for injection QJ01RA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Benzylpenicillin procaine Dihydrostreptomycin sulfate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10803/001/001 VPA10803/001/001 Pro-Dynam Oral Powder 1 g phenylbutazone per sachet Dechra Veterinary Products A/S 01/10/2000 VM Unknown AU Oral powder QM01AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Phenylbutazone Prescription Only Medicine Horse (non-food producing) N.S.A.I.D. VPA10827/001/001 VPA10827/001/001 Proactive 1.52 mg/mL Teat Dip/Spray Solution DeLaval NV 11/01/2002 VM Unknown AU Teat dip/spray solution QD08AG03 Full application (Article 12(3) of Directive No 2001/82/EC) Coarse spray Dipping Teat use Available iodine, ph. eur. (as iodine/sodium iodide/poloxamer complex 0.86) Licensed Retailer Cattle Antiseptics VPA22009/001/001 VPA22009/001/001 PROBENCIL 300 mg/ml suspension for injection for cattle and pigs MEVET S.A.U. 03/05/2019 VM Marketed AU Suspension for injection QJ01CE09 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Benzylpenicillin procaine Prescription Only Medicine Cattle Pigs Antibacterial VPA10495/006/001 VPA10495/006/001 Procactive 300 mg/ml Suspension for injection for cattle, sheep and pigs Laboratorios Syva S.A. 03/05/2019 VM AU Suspension for injection QJ01CE09 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Benzylpenicillin procaine monohydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA23462/011/001 VPA23462/011/001 Procamidor Duo 40 mg/ml + 0.036 mg/ml solution for injection VetViva Richter GmbH 30/08/2019 VM AU Solution for haemofiltration QN01BA52 Complete application (stand-alone) - Council Directive 81/851/EEC Perineural use Subcutaneous use Procaine hydrochloride Epinephrine bitartrate Prescription Only Medicine Cattle Horses Pigs Sheep Neurological Preparations VPA10826/019/001 VPA10826/019/001 Procapen Injector 3 g intramammary suspension for cattle aniMedica GmbH 27/03/2015 VM Unknown AU Intramammary suspension QJ51CE09 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramammary use Benzylpenicillin procaine monohydrate Prescription Only Medicine Cattle Antibacterial VPA22033/075/001 VPA22033/075/001 Procipen 300 mg/ml suspension for injection for cattle, sheep and pigs Bimeda Animal Health Limited 18/06/2021 VM Unknown AU Suspension for injection QJ01CE09 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Benzylpenicillin procaine Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10555/008/001 VPA10555/008/001 Procycline LA 200 mg/ml solution for injection Interchem Ireland Ltd 16/11/2012 VM Unknown AU Solution for injection QJ01AA06 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Oxytetracycline dihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10555/012/001 VPA10555/012/001 Profen Equine 100 mg/ml oral suspension for horses. Interchem (Ireland) Limited 28/06/2024 VM Unknown AU Oral suspension QP52AC13 Informed Consent application (Article 21 of Regulation (EU) 2019/6) Oral use Fenbendazole Prescription Only Medicine Horses Endoparasiticide VPA10980/039/001 VPA10980/039/001 Profexx 50 mg/ml solution for injection for cattle Alfasan Nederland B.V. 19/01/2024 VM Unknown AU Solution for injection QM01AE91 Generic application (Article 18 of Regulation (EU) 2019/6) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Cattle N.S.A.I.D. VPA10815/054/001 VPA10815/054/001 Progressis Emulsion for injection for pigs (sows and gilts) Ceva Santé Animale 06/06/2003 VM Not marketed AU Emulsion for injection QI09AA05 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Inactivated porcine reproductive and respiratory syndrome (prrs) virus, p120 strain Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA22713/001/001 VPA22713/001/001 Proin 15 mg chewable tablets for dogs Pegasus Laboratories Ireland Limited 23/03/2018 VM Temporarily Not Marketed AU Chewable tablet QG04BX91 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Phenylpropanolamine hydrochloride Prescription Only Medicine Dogs Miscellaneous VPA22713/001/002 VPA22713/001/002 Proin 50 mg chewable tablets for dogs Pegasus Laboratories Ireland Limited 23/03/2018 VM Temporarily Not Marketed AU Chewable tablet QG04BX91 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Phenylpropanolamine hydrochloride Prescription Only Medicine Dogs Miscellaneous VPA23174/001/001 VPA23174/001/001 Prolusyn 50 micrograms/ml solution for injection for cattle Syn Vet-Pharma Ireland Limited 15/05/2020 VM Unknown AU Solution for injection QH01CA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Gonadorelin acetate Prescription Only Medicine Cattle Hormone VPA25460/005/001 VPA25460/005/001 Promec 18.7 mg/g Oral Paste for Horses Acme Drugs S.r.l. 21/06/2019 VM AU Oral paste QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Horses Endectoparasiticides VPA10555/010/001 VPA10555/010/001 Promox LA 150 mg/ml Suspension for Injection Interchem (Ireland) Limited 08/06/2012 VM Unknown AU Suspension for injection QJ01CA04 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Amoxicillin trihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10836/004/001 VPA10836/004/001 Pronestesic 40 mg/ml + 0.036 mg/ml solution for injection for horses, cattle, pigs and sheep FATRO S.p.A. 15/04/2016 VM Marketed AU Solution for injection QN01BA52 Generic application (Article 13(1) of Directive No 2001/82/EC) Perineural use Subcutaneous use Procaine hydrochloride Epinephrine bitartrate Prescription Only Medicine Cattle Horses Pigs Sheep Neurological Preparations VPA10521/033/001 VPA10521/033/001 Propalin Syrup Vetoquinol S.A. 14/07/1993 VM Unknown AU Syrup QG04BX91 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Phenylpropanolamine hydrochloride Prescription Only Medicine Dogs Miscellaneous VPA10555/009/001 VPA10555/009/001 Propen 300 mg/ml Suspension for Injection for Cattle, Sheep and Pigs Interchem Ireland Ltd 30/03/2012 VM Unknown AU Suspension for injection QJ01CE09 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Benzylpenicillin procaine Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22622/034/001 VPA22622/034/001 Propodine 10 mg/ml emulsion for injection/infusion for dogs and cats Dechra Regulatory B.V. 28/06/2019 VM AU Emulsion for injection/infusion QN01AX10 Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Propofol Prescription Only Medicine Cats Dogs Neurological Preparations VPA10387/056/001 VPA10387/056/001 PropoFlo Plus 10 mg/ml, Emulsion for injection for dogs and cats Zoetis Belgium S.A. 06/11/2015 VM Unknown AU Emulsion for injection QN01AX10 Full application (Article 12(3) of Directive No 2001/82/EC) Intravenous use Propofol Prescription Only Medicine Cats Dogs Neurological Preparations VPA10664/008/001 VPA10664/008/001 Propomitor 10 mg/ml emulsion for injection/infusion for dogs and cats Orion Corporation 24/04/2020 VM Unknown AU Emulsion for injection/infusion QN01AX10 Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Propofol Prescription Only Medicine Cats Dogs Neurological Preparations VPA22873/001/001 VPA22873/001/001 Proposure 10 mg/ml emulsion for injection for dogs and cats Axience 01/03/2017 VM Marketed AU Emulsion for injection QN01AX10 Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Propofol Prescription Only Medicine Cats Dogs Neurological Preparations VPA10988/078/001 VPA10988/078/001 Prosolvin 7.5 mg/ml Solution for Injection Virbac 28/11/2008 VM Unknown AU Solution for injection QG02AD91 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Luprostiol Prescription Only Medicine Cattle Horses Pigs Hormone VPA23471/001/001 VPA23471/001/001 Protect Oral Suspension for New Born Calves Provita Eurotech Ireland Limited 30/10/1998 VM Marketed AU Oral suspension QA07 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Enterococcus faecium SF 101 Lactobacillus acidophilus, strain LA101, Live Lactobacillus acidophilus, strain LA107, Live Licensed Retailer Cattle Alimentary Tract Preparation VPA10387/102/001 VPA10387/102/001 Protivity lyophilisate and solvent for suspension for injection for cattle Zoetis Belgium S.A. 22/09/2023 VM Unknown AU Lyophilisate and solvent for suspension for injection QI02AE Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Mycoplasma bovis, strain N2805-1, Live Prescription Only Medicine Cattle Immunological - Live Vaccine VPA10988/062/001 VPA10988/062/001 PULMODOX 5 % PREMIX Virbac 12/01/2001 VM Unknown AU Premix for medicated feeding stuff QJ01AA02 Not Currently Available Oral use Doxycyline Prescription Only Medicine Pigs Antibacterial VPA22020/012/001 VPA22020/012/001 Pulmotil G100 Premix for medicated feedingstuff Elanco GmbH 24/01/1997 VM Unknown AU Premix for medicated feeding stuff QJ01FA91 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Tilmicosin phosphate Prescription Only Medicine Pigs Rabbits Antibacterial VPA22020/012/002 VPA22020/012/002 Pulmotil G200 Premix for medicated feedingstuff Elanco GmbH 24/01/1997 VM Not marketed AU Premix for medicated feeding stuff QJ01FA91 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Tilmicosin phosphate Prescription Only Medicine Pigs Rabbits Antibacterial VPA10791/010/001 VPA10791/010/001 Pulmovet 250 mg/ml solution for use in drinking water or milk replacer for cattle, pigs, chickens and turkeys Dopharma Research B.V. 04/05/2018 VM Unknown AU Solution for use in drinking water/milk QJ01FA91 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water/milk use Oral use Tilmicosin Prescription Only Medicine Cattle Chickens Pigs Turkeys Antibacterial VPA23263/001/002 VPA23263/001/002 PULSIX 100 mg/500 mg spot-on solution for dogs over 4 kg up to 10 kg Ab7 Sante 20/09/2024 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin cis:trans/40:60 Prescription Only Medicine Dogs Ectoparasiticide VPA23263/001/003 VPA23263/001/003 PULSIX 250 mg/1250 mg spot-on solution for dogs over 10 kg up to 25 kg Ab7 Sante 20/09/2024 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin cis:trans/40:60 Prescription Only Medicine Dogs Ectoparasiticide VPA23263/001/001 VPA23263/001/001 PULSIX 40 mg/200 mg spot-on solution for dogs over 1.5 kg up to 4 kg Ab7 Sante 20/09/2024 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin cis:trans/40:60 Prescription Only Medicine Dogs Ectoparasiticide VPA23263/001/004 VPA23263/001/004 PULSIX 400 mg/2000 mg spot-on solution for dogs over 25 kg up to 40 kg Ab7 Sante 20/09/2024 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin cis:trans/40:60 Prescription Only Medicine Dogs Ectoparasiticide VPA23263/001/005 VPA23263/001/005 PULSIX 600 mg/3000 mg spot-on solution for dogs over 40 kg up to 60 kg Ab7 Sante 20/09/2024 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin cis:trans/40:60 Prescription Only Medicine Dogs Ectoparasiticide VPA10782/042/001 VPA10782/042/001 Pyrocam 15 mg/ml oral suspension for pigs Huvepharma NV 18/08/2023 VM Unknown AU Oral suspension QM01AC06 Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) Oral use Meloxicam Prescription Only Medicine Pigs N.S.A.I.D. VPA10782/045/001 VPA10782/045/001 Pyrocam 20 mg/ml solution for injection Huvepharma NV 17/05/2024 VM Unknown AU Solution for injection QM01AC06 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Subcutaneous use Meloxicam Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10509/012/001 VPA10509/012/001 Qivitan 25 mg/ml suspension for injection for cattle and pigs Industrial Veterinaria S.A. 27/01/2017 VM Unknown AU Suspension for injection QJ01DE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cefquinome sulfate Prescription Only Medicine Cattle Pigs Antibacterial VPA10509/015/001 VPA10509/015/001 Qivitan LC 75 mg intramammary ointment for lactating cows Industrial Veterinaria S.A. 01/06/2018 VM Unknown AU Intramammary ointment QJ51DE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Cefquinome sulfate Prescription Only Medicine Cattle Antibacterial VPA22693/002/001 VPA22693/002/001 Qualimec 10 mg/ml Solution for Injection. ECO Animal Health Europe Limited 01/01/1900 VM Unknown AU Solution for injection QP54AA01 Well-established use application (Article 13a of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA10987/063/001 VPA10987/063/001 Quanifen (50 mg Praziquantel/500 mg Fenbendazole) Tablets for Cats and Dogs Chanelle Pharmaceuticals Manufacturing Limited 22/04/2005 VM Not marketed AU Tablet QP52AA51 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Praziquantel Fenbendazole Companion Animal Medicine Cats Dogs Endoparasiticide VPA10987/062/001 VPA10987/062/001 Quenazole (50 mg praziquantel/500 mg Fenbendazole) Tablets for Cats and Dogs Chanelle Pharmaceuticals Manufacturing Limited 22/04/2005 VM Not marketed AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Fenbendazole Companion Animal Medicine Cats Dogs Endoparasiticide VPA10477/001/001 VPA10477/001/001 Quinoflox 100 mg/ml solution for injection for cattle and pigs GLOBAL VET HEALTH SL 11/01/2013 VM Marketed AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10782/051/001 VPA10782/051/001 Quinox 6 mg/g oral powder for cattle and sheep Huvepharma NV 26/06/2026 VM Unknown AU Oral powder QP51BX04 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Decoquinate Prescription Only Medicine Cattle Sheep Coccidiostats VPA10782/052/001 VPA10782/052/001 Quinox 60.6 mg/g Premix for Medicated Feeding Stuff for Cattle and Sheep Huvepharma NV 26/06/2026 VM Unknown AU Premix for medicated feeding stuff QP51BX04 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Decoquinate Prescription Only Medicine Cattle Sheep Coccidiostats VPA10454/074/001 VPA10454/074/001 Rabisin Boehringer Ingelheim Vetmedica GmbH 10/08/2004 VM Unknown AU Suspension for injection QI07AA02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Rabies virus glycoprotein Prescription Only Medicine Cats Cattle Dogs Ferrets Horses Mink Polecat Sheep Immunological - Inactivated Vaccine VPA10990/027/001 VPA10990/027/001 Ranide 30 mg/ml Oral Drench Univet Limited 17/02/1995 VM Unknown AU Oral suspension QP52AG05 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Rafoxanide Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10989/056/001 VPA10989/056/001 Rapidexon 2 mg/ml solution for injection Eurovet Animal Health B.V. 04/04/2008 VM Unknown AU Solution for injection QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intraarticular use Intrabursal use Intramuscular use Intravenous use Dexamethasone sodium phosphate Prescription Only Medicine Cats Cattle Dogs Horses Pigs Corticosteroid VPA10996/123/001 VPA10996/123/001 Receptal 4 microgram/ml solution for injection Intervet Ireland Limited 01/10/1999 VM Unknown AU Solution for injection QH01CA90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Buserelin Prescription Only Medicine Cattle Horses Pigs Rabbits Trout Hormone VPA10475/025/001 VPA10475/025/001 Recicort 1.77 mg/ml + 17.7 mg/ml ear drops, solution for dogs and cats Le Vet Beheer B.V. 10/03/2017 VM Unknown AU Ear drops, solution QD07XB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Auricular use Triamcinolone acetonide Salicylic acid Prescription Only Medicine Cats Dogs Corticosteroid VPA10980/027/001 VPA10980/027/001 Recudon 2.5 mg/ml + 0.125 mg/ml solution for injection for horses and dogs Alfasan Nederland B.V. 17/07/2023 VM Unknown AU Solution for injection QN02AC52 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Levomethadone hydrochloride Fenpipramide hydrochloride Prescription Only Medicine Dogs Horses Neurological Preparations VPA10980/027/002 VPA10980/027/002 Recudon 5.0 mg/ml + 0.25 mg/ml solution for injection for horses and dogs Alfasan Nederland B.V. 17/07/2023 VM Unknown AU Solution for injection QN02AC52 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Intramuscular use Intravenous use Levomethadone hydrochloride Fenpipramide hydrochloride Prescription Only Medicine Dogs Horses Neurological Preparations VPA10990/054/001 VPA10990/054/001 Redymox 150 mg/ml suspension for injection for cattle, sheep, pigs, dogs and cats Univet Limited 15/08/2025 VM Unknown AU Suspension for injection QJ01CA04 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Subcutaneous use Amoxicillin trihydrate Prescription Only Medicine Cats Cattle Dogs Pigs Sheep Antibacterial VPA10516/025/002 VPA10516/025/002 REFORDOG 100 mg/500 mg spot-on solution for dogs over 4 kg up to 10 kg Vetpharma Animal Health S.L. 20/09/2024 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin cis:trans/40:60 Prescription Only Medicine Dogs Ectoparasiticide VPA10516/025/003 VPA10516/025/003 REFORDOG 250 mg/1250 mg spot-on solution for dogs over 10 kg up to 25 kg Vetpharma Animal Health S.L. 20/09/2024 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin cis:trans/40:60 Prescription Only Medicine Dogs Ectoparasiticide VPA10516/025/001 VPA10516/025/001 REFORDOG 40 mg/200 mg spot-on solution for dogs over 1.5 kg up to 4 kg Vetpharma Animal Health S.L. 20/09/2024 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin cis:trans/40:60 Prescription Only Medicine Dogs Ectoparasiticide VPA10516/025/004 VPA10516/025/004 REFORDOG 400 mg/2000 mg spot-on solution for dogs over 25 kg up to 40 kg Vetpharma Animal Health S.L. 20/09/2024 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin cis:trans/40:60 Prescription Only Medicine Dogs Ectoparasiticide VPA10516/025/005 VPA10516/025/005 REFORDOG 600 mg/3000 mg spot-on solution for dogs over 40 kg up to 60 kg Vetpharma Animal Health S.L. 20/09/2024 VM Unknown AU Spot-on solution QP53AC54 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Imidacloprid Permethrin cis:trans/40:60 Prescription Only Medicine Dogs Ectoparasiticide VPA10996/124/001 VPA10996/124/001 Regumate Equine 2.2 mg/ml oral solution for horses Intervet Ireland Limited 01/10/1997 VM Unknown AU Oral solution QG03DX90 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Altrenogest Prescription Only Medicine Horses Hormone VPA22969/004/001 VPA22969/004/001 Relaquine 35 mg/ml Oral Gel for Horses Floris Holding BV 05/06/2026 VM Unknown AU Oral gel QN05AA04 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Acepromazine maleate Prescription Only Medicine Horses Neurological Preparations VPA10660/001/001 VPA10660/001/001 Release 300 mg/ml, solution for injection WDT - Wirtschaftsgenossenschaft deutscher Tierarzte eG, 24/10/2008 VM Marketed AU Solution for injection QN51AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intracardiac use Intraperitoneal use Intrapulmonary use Intravenous use Pentobarbital sodium Prescription Only Medicine Cats Cattle Chickens Chinchilla Dogs Gerbil Guinea pig Hamster Hare Mink Mouse Ornamental birds Pigeons Polecat Rat Reptiles Horse (non-food producing) Rabbit (non-food-producing) Neurological Preparations VPA10996/254/001 VPA10996/254/001 Repidose Ready Pulse Intervet Ireland Limited 01/10/1999 VM Unknown AU Pulsatile-release intraruminal device QP52AC02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Oxfendazole Prescription Only Medicine Cattle Endoparasiticide VPA10475/030/001 VPA10475/030/001 Repose 500 mg/ml solution for injection Le Vet Beheer B.V. 05/05/2017 VM Not marketed AU Solution for injection QN51AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intracardiac use Intraperitoneal use Intravenous use Pentobarbital sodium Prescription Only Medicine Cats Cattle Chinchilla Dogs Gerbil Goats Guinea pig Hamster Horses Mink Mouse Pigs Rabbits Rat Sheep Neurological Preparations VPA10521/002/001 VPA10521/002/001 Reprocine 0.07 mg/ml solution for injection for cattle and pigs Vetoquinol S.A. 05/11/2004 VM Unknown AU Solution for injection QH01BB03 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramuscular use Intravenous use Carbetocin Prescription Only Medicine Cattle Pigs Hormone VPA10454/012/001 VPA10454/012/001 ReproCyc PRRS EU lyophilisate and solvent for suspension for injection for pigs Boehringer Ingelheim Vetmedica GmbH 02/04/2015 VM Unknown AU Lyophilisate and solvent for suspension for injection QI09AD03 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Live attenuated prrs 94881 virus Prescription Only Medicine Pigs Immunological - Live Vaccine VPA22664/085/001 VPA22664/085/001 Resflam 300/20 mg/ml Solution for Injection for Cattle Norbrook Laboratories (Ireland) Limited 25/09/2009 VM Unknown AU Solution for injection QJ01AA56 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Oxytetracycline dihydrate Flunixin meglumine Prescription Only Medicine Cattle Antibacterial VPA10996/255/001 VPA10996/255/001 RESFLOR 300/16.5 mg/mL Solution for Injection for Cattle Intervet Ireland Limited 14/09/2007 VM Marketed AU Solution for injection QJ01BA99 Fixed combination application (Article 13b of Directive No 2001/82/EC) Subcutaneous use Flunixin meglumine Florfenicol Prescription Only Medicine Cattle Antibacterial VPA10555/004/001 VPA10555/004/001 RESPICHLOR 15% w/w Oral Powder Interchem Ireland Ltd 29/06/2001 VM Unknown AU Oral powder QJ01AA03 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Chlortetracycline hydrochloride Prescription Only Medicine Cattle Antibacterial VPA10810/004/001 VPA10810/004/001 Revertor 5 mg/ml Solution for Injection for Dogs and Cats CP-Pharma Handelsgesellschaft mbH 25/04/2008 VM Unknown AU Solution for injection QV03AB90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Atipamezole hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10989/071/001 VPA10989/071/001 Revozyn RTU 400 mg/ml suspension for injection for cattle Eurovet Animal Health B.V. 23/02/2018 VM Unknown AU Suspension for injection QJ01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Penethamate hydriodide Prescription Only Medicine Cattle Antibacterial VPA10509/006/001 VPA10509/006/001 Rhemox 500 mg/g powder for use in drinking water for pigs, chicken broilers, duck broilers and turkeys for meat production Industrial Veterinaria S.A. 16/10/2015 VM Marketed AU Powder for use in drinking water QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Amoxicillin trihydrate Prescription Only Medicine Chickens Duck Pigs Turkeys Antibacterial VPA22715/004/001 VPA22715/004/001 Rhinovac IBR Marker live Lyophilisate and solvent for suspension for injection or nasal spray for cattle. Animal Health Distributors Limited 10/09/2021 VM Unknown AU Lyophilisate and solvent for suspension for injection QI02AD01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Nasal use Bovine herpesvirus 1, strain bio-27 live Prescription Only Exempt Cattle Immunological - Live Vaccine VPA10954/012/001 VPA10954/012/001 Ridacox 50 mg/ml oral suspension for cattle and sheep J & M Veterinary Services Limited 17/04/2015 VM Unknown AU Oral suspension QP51AJ01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Toltrazuril Prescription Only Medicine Cattle Sheep Coccidiostats VPA10987/112/001 VPA10987/112/001 Ridamec 1 mg/ml oral solution for sheep Chanelle Pharmaceuticals Manufacturing Limited 25/08/2017 VM Marketed AU Oral solution QP54AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Moxidectin Prescription Only Medicine Sheep Endectoparasiticides HOVR10537/019/001 HOVR10537/019/001 Ridomast Galway Homeopathics (Manufacturing) Limited 22/09/2023 VM Unknown AU Oral liquid Not Currently Available Oral use Bryonia Carbo vegetabilis Phytolacca americana Acidum silicicum Sulfur Licensed Retailer Camel Cattle Goats Sheep Homeopathic VPA23462/001/001 VPA23462/001/001 Rifen 100 mg/ml solution for injection for horses, cattle and pigs VetViva Richter GmbH 23/04/2010 VM Unknown AU Solution for injection QM01AE03 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Ketoprofen Prescription Only Medicine Cattle Horses Pigs N.S.A.I.D. VPA10988/018/002 VPA10988/018/002 Rilexine 300 mg Tablets for dogs Virbac 01/10/1988 VM Unknown AU Tablet QJ01DB01 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Cefalexin monohydrate Prescription Only Medicine Dogs Antibacterial VPA10988/018/003 VPA10988/018/003 Rilexine 600 mg Tablets for dogs Virbac 21/09/2001 VM Unknown AU Tablet QJ01DB01 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Cefalexin monohydrate Prescription Only Medicine Dogs Antibacterial VPA10988/018/001 VPA10988/018/001 Rilexine 75 mg Tablets for dogs and cats Virbac 01/10/1988 VM Unknown AU Tablet QJ01DB01 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Cefalexin monohydrate Prescription Only Medicine Cats Dogs Antibacterial VPA10988/115/001 VPA10988/115/001 Rilexine DC 375 mg intramammary suspension for dry cows Virbac 08/07/2022 VM Unknown AU Intramammary suspension QJ51DB01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Cephalexin benzathine Prescription Only Medicine Cattle Antibacterial VPA10387/058/001 VPA10387/058/001 RIMADYL Cattle 50 mg/ml Solution for Injection Zoetis Belgium S.A. 28/02/2014 VM Unknown AU Solution for injection QM01AE91 Full application (Article 12(3) of Directive No 2001/82/EC) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Cattle N.S.A.I.D. VPA10387/059/003 VPA10387/059/003 Rimadyl Palatable Tablets 100 mg Zoetis Belgium S.A. 06/03/2015 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10387/059/001 VPA10387/059/001 Rimadyl Palatable Tablets 20 mg Zoetis Belgium S.A. 06/03/2015 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10387/059/002 VPA10387/059/002 Rimadyl Palatable Tablets 50 mg Zoetis Belgium S.A. 06/03/2015 VM Unknown AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/066/003 VPA10987/066/003 Rimifin 100 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 02/06/2006 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/066/001 VPA10987/066/001 Rimifin 20 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 02/06/2006 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/066/002 VPA10987/066/002 Rimifin 50 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 02/06/2006 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10387/100/001 VPA10387/100/001 Rispoval 2/BRSV + Pi3 Lyophilisate and solvent for suspension for injection for cattle Zoetis Belgium S.A. 19/02/2021 VM Unknown AU Lyophilisate and solvent for suspension for injection QI02AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Bovine Para Influenza 3 Virus, live Bovine respiratory syncytial virus, live Prescription Only Exempt Cattle Immunological - Live Vaccine VPA10387/060/001 VPA10387/060/001 Rispoval 3 BRSV Pi3 BVD Lyophilisate and suspension for suspension for injection for cattle Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Lyophilisate and suspension for suspension for injection QI02AH Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Parainfluenza 3 virus, modified live, strain rlb103 Bovine respiratory syncytial virus, modified live, strain 375 Inactivated bovine viral diarrhoea virus 1, strain 5960 (cytopathic) Inactivated bovine viral diarrhoea virus type 1 strain 6309 (non cytopathic) Prescription Only Exempt Cattle Immunological - Mixed Vaccine (L & A) VPA10387/061/001 VPA10387/061/001 Rispoval IBR-Marker Inactivated Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Suspension for injection QI02AA03 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Bovine herpes virus type 1 (BHV-1), strain difivac Prescription Only Exempt Cattle Immunological - Inactivated Vaccine VPA10387/062/001 VPA10387/062/001 Rispoval IBR-Marker Live Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Lyophilisate and solvent for suspension for injection QI02AD01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intranasal use Bovine herpes virus type 1 (BHV-1), strain difivac (gE-negative), modified live (attenuated) virus Prescription Only Exempt Cattle Immunological - Live Vaccine VPA10387/064/001 VPA10387/064/001 Rispoval RS+PI3 IntraNasal Zoetis Belgium S.A. 09/12/2013 VM Unknown AU pdr and diluent for intra-nasal soln QI02AD07 Full application (Article 12(3) of Directive No 2001/82/EC) Intranasal use Bovine parainfluenza 3 virus (pi3v), rlb 103, attenuated Bovine respiratory syncytial virus (brsv), strain 375 attenuated Prescription Only Exempt Cattle Immunological - Live Vaccine VPA25237/004/001 VPA25237/004/001 Robenord 20 mg/ml solution for injection for cats and dogs Accord Healthcare B.V. 20/03/2026 VM Unknown AU Solution for injection QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Subcutaneous use Robenacoxib Prescription Only Medicine Cats Dogs N.S.A.I.D. VPA10987/183/002 VPA10987/183/002 Robentrol 10 mg tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 01/08/2025 VM Unknown AU Tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/183/003 VPA10987/183/003 Robentrol 20 mg tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 01/08/2025 VM Unknown AU Tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/183/004 VPA10987/183/004 Robentrol 40 mg tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 01/08/2025 VM Unknown AU Tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/183/001 VPA10987/183/001 Robentrol 5 mg tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 01/08/2025 VM Unknown AU Tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/184/001 VPA10987/184/001 Robentrol 6 mg tablets for cats Chanelle Pharmaceuticals Manufacturing Limited 30/05/2025 VM Unknown AU Tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Cats N.S.A.I.D. VPA10774/075/002 VPA10774/075/002 Robexera 10 mg chewable tablets for dogs Krka, d.d., Novo mesto 21/08/2023 VM Unknown AU Chewable tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/078/001 VPA10774/078/001 Robexera 20 mg/ml solution for injection for cats and dogs Krka, d.d., Novo mesto 01/08/2025 VM Unknown AU Solution for injection QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Subcutaneous use Robenacoxib Prescription Only Medicine Cats Dogs N.S.A.I.D. VPA10774/075/003 VPA10774/075/003 Robexera 20 mg chewable tablets for dogs Krka, d.d., Novo mesto 21/08/2023 VM Unknown AU Chewable tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/075/004 VPA10774/075/004 Robexera 40 mg chewable tablets for dogs Krka, d.d., Novo mesto 21/08/2023 VM Unknown AU Chewable tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/075/001 VPA10774/075/001 Robexera 5 mg chewable tablets for dogs Krka, d.d., Novo mesto 21/08/2023 VM Unknown AU Chewable tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/075/005 VPA10774/075/005 Robexera 6 mg chewable tablets for cats Krka, d.d., Novo mesto 08/12/2025 VM Unknown AU Chewable tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Cats N.S.A.I.D. VPA22664/104/001 VPA22664/104/001 Robonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle Norbrook Laboratories (Ireland) Limited 01/03/2013 VM Unknown AU Pour-on solution QP54AA04 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/067/003 VPA10987/067/003 Rofeniflex 100 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 02/06/2006 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/067/001 VPA10987/067/001 Rofeniflex 20 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 02/06/2006 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10987/067/002 VPA10987/067/002 Rofeniflex 50 mg Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 02/06/2006 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/076/002 VPA10774/076/002 Rogiola 10 mg chewable tablets for dogs Krka, d.d., Novo mesto 21/08/2023 VM Unknown AU Chewable tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/076/003 VPA10774/076/003 Rogiola 20 mg chewable tablets for dogs Krka, d.d., Novo mesto 21/08/2023 VM Unknown AU Chewable tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/076/004 VPA10774/076/004 Rogiola 40 mg chewable tablets for dogs Krka, d.d., Novo mesto 21/08/2023 VM Unknown AU Chewable tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/076/001 VPA10774/076/001 Rogiola 5 mg chewable tablets for dogs Krka, d.d., Novo mesto 21/08/2023 VM Unknown AU Chewable tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/076/005 VPA10774/076/005 Rogiola 6 mg chewable tablets for cats Krka, d.d., Novo mesto 08/12/2025 VM Unknown AU Chewable tablet QM01AH91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Robenacoxib Prescription Only Medicine Cats N.S.A.I.D. VPA22028/004/001 VPA22028/004/001 Rokopig Entero emulsion for injection for pigs Bioveta, a.s. 28/03/2024 VM Unknown AU Emulsion for injection QI09AL Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Porcine rotavirus, strain OSU 6, inactivated Escherichia coli, strain O149:K88, fimbrial adhesin F4, Inactivated Escherichia coli, strain K85:987P, fimbrial adhesin F6, Inactivated Escherichia coli O101:K99, fimbrial adhesin F5 and F41, Inactivated Clostridium Perfringens Type C, Beta Toxoid Prescription Only Medicine Pigs Immunological - Inactivated Vaccine VPA22715/005/001 VPA22715/005/001 Rokopig, emulsion for injection for pigs Animal Health Distributors Limited 30/06/2023 VM Unknown AU Emulsion for injection QI09AL02 Similar biological application (Article 13(4) of Directive No 2001/82/EC) Intramuscular use Porcine rotavirus, strain OSU 6, inactivated Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated Escherichia Coli 0149:K91,K88 (F4), Inactivated Escherichia Coli 0147:K88(F4), Inactivated Escherichia Coli K85:987P (F6), Inactivated Escherichia coli O101:K99, fimbrial adhesin F5 and F41, Inactivated Prescription Only Medicine Pigs Immunological VPA10475/040/001 VPA10475/040/001 Rominervin 10 mg/ml solution for injection for horses Le Vet Beheer B.V. 26/10/2018 VM AU Solution for injection QN05CM93 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Romifidine hydrochloride Prescription Only Medicine Horses Neurological Preparations VPA10454/075/002 VPA10454/075/002 Ronaxan 100 mg tablets for dogs and cats Boehringer Ingelheim Vetmedica GmbH 12/10/1990 VM Unknown AU Tablet QJ01AA02 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Doxycycline hyclate Prescription Only Medicine Cats Dogs Antibacterial VPA10454/075/001 VPA10454/075/001 Ronaxan 20 mg tablets for dogs and cats Boehringer Ingelheim Vetmedica GmbH 12/10/1995 VM Unknown AU Tablet QJ01AA02 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Doxycycline hyclate Prescription Only Medicine Cats Dogs Antibacterial PVPA10400/002/001 PVPA10400/002/001 Rotacoli Suis emulsion for injection for pigs Duggan Veterinary Supplies Limited 05/12/2025 VM Unknown AU Emulsion for injection Not Currently Available Not Currently Available Porcine rotavirus, strain OSU 6, inactivated Escherichia coli, strain O149:K88, fimbrial adhesin F4, Inactivated Escherichia coli O101:K99, fimbrial adhesin F5 and F41, Inactivated Escherichia coli, strain K85:987P, fimbrial adhesin F6, Inactivated Clostridium Perfringens Type C, Beta Toxoid Not applicable Pigs Immunological - Inactivated Vaccine VPA10665/002/001 VPA10665/002/001 ROXACIN 100 mg/ml solution for injection for cattle and pigs LABORATORIOS CALIER S.A. 15/07/2011 VM Marketed AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10987/113/001 VPA10987/113/001 Rumenil 34 mg/ml oral suspension for cattle Chanelle Pharmaceuticals Manufacturing Limited 19/02/2016 VM Unknown AU Oral suspension QP52AG05 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Oxyclozanide Prescription Only Medicine Cattle Endoparasiticide VPA10774/027/003 VPA10774/027/003 Rycarfa 100 mg tablets for dogs Krka, d.d., Novo mesto 02/05/2014 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/027/001 VPA10774/027/001 Rycarfa 20 mg tablets for dogs Krka, d.d., Novo mesto 02/05/2014 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10774/028/001 VPA10774/028/001 Rycarfa 50 mg/ml solution for injection for dogs and cats Krka, d.d., Novo mesto 11/07/2014 VM Not marketed AU Solution for injection QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Subcutaneous use Carprofen Prescription Only Medicine Cats Dogs N.S.A.I.D. VPA10774/027/002 VPA10774/027/002 Rycarfa 50 mg tablets for dogs Krka, d.d., Novo mesto 02/05/2014 VM Not marketed AU Tablet QM01AE91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Carprofen Prescription Only Medicine Dogs N.S.A.I.D. VPA10815/064/001 VPA10815/064/001 Salmoporc lyophilisate and solvent for suspension for injection for pigs Ceva Santé Animale 18/04/2019 VM AU Lyophilisate and solvent for suspension for injection QI09AE02 Similar biological application (Article 13(4) of Directive No 2001/82/EC) Oral use Subcutaneous use Salmonella typhimurium mutant, strain 421/125 Prescription Only Medicine Pigs Immunological - Live Vaccine VPA10815/064/002 VPA10815/064/002 Salmoporc lyophilisate for oral suspension for pigs Ceva Santé Animale 18/04/2019 VM AU Lyophilisate for oral suspension QI09AE02 Similar biological application (Article 13(4) of Directive No 2001/82/EC) Oral use Salmonella typhimurium mutant, strain 421/125 Prescription Only Medicine Pigs Immunological - Live Vaccine VPA10983/057/001 VPA10983/057/001 Sedalin Oral Gel 3.5 %w/v Vetoquinol Ireland Limited 01/10/2000 VM Unknown AU Oral gel QN05AA04 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Acepromazine maleate Prescription Only Medicine Dogs Horse (non-food producing) Neurological Preparations VPA23462/012/001 VPA23462/012/001 Sedanol 40 mg/ml solution for injection for pigs VetViva Richter GmbH 28/02/2020 VM Unknown AU Solution for injection QN05AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Azaperone Prescription Only Medicine Pigs Neurological Preparations VPA10816/008/001 VPA10816/008/001 Sedastart 1 mg/ml solution for injection for cats and dogs Le Vet BV 23/04/2010 VM Unknown AU Solution for injection QN05CM91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Medetomidine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10816/009/001 VPA10816/009/001 Sedastop 5 mg/ml solution for injection for cats and dogs Le Vet BV 28/05/2010 VM Unknown AU Solution for injection QV03AB90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Atipamezole hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10989/057/001 VPA10989/057/001 SEDATOR, 1.0 mg/ml, solution for injection for cats and dogs Eurovet Animal Health B.V. 26/09/2008 VM Unknown AU Solution for injection QN05CM91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Medetomidine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10989/050/001 VPA10989/050/001 Sedaxylan, 20 mg/ml solution for injection for dogs, cats, horses and cattle Eurovet Animal Health B.V. 02/05/2003 VM Unknown AU Solution for injection QN05CM92 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Xylazine Hydrochloride Prescription Only Medicine Cats Cattle Dogs Horses Neurological Preparations VPA10509/007/001 VPA10509/007/001 Sedecalm 1 mg/ml solution for injection for dogs and cats Industrial Veterinaria S.A. 05/02/2016 VM Not marketed AU Solution for injection QN05CM91 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Medetomidine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA22812/002/001 VPA22812/002/001 Sedectin 20 mg/ml solution for injection for cattle, horses, dogs and cats Interchemie Werken De Adelaar Eesti AS. 26/03/2021 VM Unknown AU Solution for injection QN05CM92 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Xylazin hydrochloride Prescription Only Medicine Cats Cattle Dogs Horses Neurological Preparations VPA10454/013/001 VPA10454/013/001 Sedivet 10 mg/ml Solution for Injection for horses Boehringer Ingelheim Vetmedica GmbH 29/03/1996 VM Marketed AU Solution for injection QN05CM93 Full application (Article 12(3) of Directive No 2001/82/EC) Intravenous use Romifidine hydrochloride Prescription Only Medicine Horses Neurological Preparations VPA10774/056/003 VPA10774/056/003 Selames 120 mg spot-on solution for dogs 10.1–20.0 kg Krka, d.d., Novo mesto 21/12/2018 VM AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/055/001 VPA10774/055/001 Selames 15 mg spot-on solution for cats and dogs = 2.5 kg Krka, d.d., Novo mesto 21/12/2018 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Cats Dogs Endectoparasiticides VPA10774/056/004 VPA10774/056/004 Selames 240 mg spot-on solution for dogs 20.1–40.0 kg Krka, d.d., Novo mesto 21/12/2018 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/056/001 VPA10774/056/001 Selames 30 mg spot-on solution for dogs 2.6–5.0 kg Krka, d.d., Novo mesto 21/12/2018 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/056/005 VPA10774/056/005 Selames 360 mg spot-on solution for dogs 40.1–60.0 kg Krka, d.d., Novo mesto 21/12/2018 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/055/002 VPA10774/055/002 Selames 45 mg spot-on solution for cats 2.6–7.5 kg Krka, d.d., Novo mesto 21/12/2018 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Cats Dogs Endectoparasiticides VPA10774/055/003 VPA10774/055/003 Selames 60 mg spot-on solution for cats 7.6–10.0 kg Krka, d.d., Novo mesto 21/12/2018 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Cats Dogs Endectoparasiticides VPA10774/056/002 VPA10774/056/002 Selames 60 mg spot-on solution for dogs 5.1–10.0 kg Krka, d.d., Novo mesto 21/12/2018 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA22664/144/006 VPA22664/144/006 SELAPRO 120 mg spot-on solution for medium dogs (10.1–20.0 kg) Norbrook Laboratories (Ireland) Limited 26/10/2018 VM AU Spot-on solution QP54AA05 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA22664/144/001 VPA22664/144/001 SELAPRO 15 mg spot-on solution for dogs and cats (< 2.5 kg) Norbrook Laboratories (Ireland) Limited 26/10/2018 VM AU Spot-on solution QP54AA05 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Cats Dogs Endectoparasiticides VPA22664/144/007 VPA22664/144/007 SELAPRO 240 mg spot-on solution for large dogs (20.1–40.0 kg) Norbrook Laboratories (Ireland) Limited 26/10/2018 VM AU Spot-on solution QP54AA05 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA22664/144/004 VPA22664/144/004 SELAPRO 30 mg spot-on solution for very small dogs (2.6–5.0 kg) Norbrook Laboratories (Ireland) Limited 26/10/2018 VM AU Spot-on solution QP54AA05 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA22664/144/008 VPA22664/144/008 SELAPRO 360 mg spot-on solution for very large dogs (40.1–60.0 kg) Norbrook Laboratories (Ireland) Limited 26/10/2018 VM AU Spot-on solution QP54AA05 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA22664/144/002 VPA22664/144/002 SELAPRO 45 mg spot-on solution for cats (2.6–7.5 kg) Norbrook Laboratories (Ireland) Limited 26/10/2018 VM AU Spot-on solution QP54AA05 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Cats Endectoparasiticides VPA22664/144/003 VPA22664/144/003 SELAPRO 60 mg spot-on solution for large cats (7.6–10.0 kg) Norbrook Laboratories (Ireland) Limited 26/10/2018 VM AU Spot-on solution QP54AA05 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Cats Endectoparasiticides VPA22664/144/005 VPA22664/144/005 SELAPRO 60 mg spot-on solution for small dogs (5.1–10.0 kg) Norbrook Laboratories (Ireland) Limited 26/10/2018 VM AU Spot-on solution QP54AA05 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA10846/008/001 VPA10846/008/001 SELECTAN 300 mg/ml solution for injection for cattle and pigs Laboratorios Hipra S.A. 15/02/2008 VM Marketed AU Solution for injection QJ01BA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Florfenicol Prescription Only Medicine Cattle Pigs Antibacterial VPA10774/054/003 VPA10774/054/003 Selehold 120 mg spot-on solution for dogs 10.1–20.0 kg Krka, d.d., Novo mesto 17/05/2019 VM AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/053/001 VPA10774/053/001 Selehold 15 mg spot-on solution for cats and dogs = 2.5 kg Krka, d.d., Novo mesto 17/05/2019 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Cats Dogs Endectoparasiticides VPA10774/054/004 VPA10774/054/004 Selehold 240 mg spot-on solution for dogs 20.1–40.0 kg Krka, d.d., Novo mesto 17/05/2019 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/054/001 VPA10774/054/001 Selehold 30 mg spot-on solution for dogs 2.6–5.0 kg Krka, d.d., Novo mesto 17/05/2019 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/054/005 VPA10774/054/005 Selehold 360 mg spot-on solution for dogs 40.1–60.0 kg Krka, d.d., Novo mesto 17/05/2019 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA10774/053/002 VPA10774/053/002 Selehold 45 mg spot-on solution for cats 2.6–7.5 kg Krka, d.d., Novo mesto 17/05/2019 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Cats Endectoparasiticides VPA10774/053/003 VPA10774/053/003 Selehold 60 mg spot-on solution for cats 7.6–10.0 kg Krka, d.d., Novo mesto 17/05/2019 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Cats Endectoparasiticides VPA10774/054/002 VPA10774/054/002 Selehold 60 mg spot-on solution for dogs 5.1–10.0 kg Krka, d.d., Novo mesto 17/05/2019 VM Not marketed AU Spot-on solution QP54AA05 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Selamectin Prescription Only Medicine Dogs Endectoparasiticides VPA10815/062/002 VPA10815/062/002 Selgian 20 kg, Film coated tablets Ceva Santé Animale 05/09/1997 VM Not marketed AU Film-coated tablet QN06A Not Currently Available Oral use Selegiline hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10815/062/003 VPA10815/062/003 Selgian 40 kg, Film coated tablets Ceva Santé Animale 22/11/2002 VM Not marketed AU Film-coated tablet QN06A Not Currently Available Oral use Selegiline hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10815/062/001 VPA10815/062/001 Selgian 8 kg, Film coated tablets Ceva Santé Animale 05/09/1997 VM Not marketed AU Film-coated tablet QN06A Not Currently Available Oral use Selegiline hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10836/006/002 VPA10836/006/002 SEMELCEF 1000 mg tablets for dogs FATRO S.p.A. 28/06/2019 VM Marketed AU Tablet QJ01DB05 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefadroxil Prescription Only Medicine Dogs Antibacterial VPA10836/006/001 VPA10836/006/001 SEMELCEF 200 mg tablets for dogs and cats FATRO S.p.A. 28/06/2019 VM Marketed AU Tablet QJ01DB05 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefadroxil Prescription Only Medicine Cats Dogs Antibacterial VPA10539/005/001 VPA10539/005/001 Sensiblex 40 mg/ml solution for injection for cattle Veyx-Pharma GmbH 30/06/2017 VM Unknown AU Solution for injection QG02CX90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Denaverine hydrochloride Prescription Only Medicine Cattle Hormone VPA10996/257/001 VPA10996/257/001 SLICE 2 mg/g premix for medicated feeding stuff for Atlantic salmon Intervet Ireland Limited 27/10/2000 VM Unknown AU Premix for medicated feeding stuff QP54AA06 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Emamectin benzoate Prescription Only Medicine Atlantic salmon Ectoparasiticide VPA10465/004/001 VPA10465/004/001 Sodium Chloride 0.9 g/100 ml B. Braun Vet Care solution for infusion for cattle, horses, sheep, goats, pigs, dogs and cats B. Braun Melsungen AG. 04/10/2013 VM Unknown AU Solution for infusion QB05BB01 Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Sodium chloride Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Sheep Electrolytes VPA10791/003/001 VPA10791/003/001 Sodium Salicyl 800 mg/g powder for oral solution for cattle (calves) and pigs Dopharma Research B.V. 14/10/2011 VM Unknown AU Powder for oral solution QN02BA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Sodium salicylate Prescription Only Medicine Cattle Pigs N.S.A.I.D. VPA10989/054/001 VPA10989/054/001 Solacyl 1000 mg/g, powder for oral solution for cattle and pigs Eurovet Animal Health B.V. 29/08/2008 VM Unknown AU Powder for oral solution QN02BA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Sodium salicylate Prescription Only Medicine Cattle Pigs N.S.A.I.D. VPA10989/064/001 VPA10989/064/001 Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys Eurovet Animal Health B.V. 01/04/2016 VM Unknown AU Powder for oral solution QJ01CA04 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Amoxicillin Prescription Only Medicine Chickens Duck Turkeys Antibacterial VPA22664/150/001 VPA22664/150/001 Solantel 200 mg/ml Pour-On Solution for Cattle Norbrook Laboratories (Ireland) Limited 11/06/2021 VM Unknown AU Pour-on solution QP52AG09 Full application (Article 12(3) of Directive No 2001/82/EC) Pour-on use Closantel sodium dihydrate Prescription Only Medicine Cattle Endoparasiticide VPA22664/128/001 VPA22664/128/001 Solantel 50 mg/ml Oral Suspension for Sheep Norbrook Laboratories (Ireland) Limited 26/08/2016 VM Unknown AU Oral suspension QP52AG09 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Closantel sodium dihydrate Prescription Only Medicine Sheep Endoparasiticide VPA10988/069/001 VPA10988/069/001 Soloxine 0.1 mg Tablet Virbac 19/01/2007 VM Unknown AU Tablet QH03AA01 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10988/069/002 VPA10988/069/002 Soloxine 0.2 mg Tablet Virbac 19/01/2007 VM Unknown AU Tablet QH03AA01 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10988/069/003 VPA10988/069/003 Soloxine 0.3 mg Tablet Virbac 19/01/2007 VM Unknown AU Tablet QH03AA01 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10988/069/004 VPA10988/069/004 Soloxine 0.5 mg Tablet Virbac 19/01/2007 VM Unknown AU Tablet QH03AA01 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10988/069/005 VPA10988/069/005 Soloxine 0.8 mg Tablet Virbac 19/01/2007 VM Unknown AU Tablet QH03AA01 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10555/011/001 VPA10555/011/001 Soluchlor 150 mg/g Oral Powder for Calves Interchem (Ireland) Limited 07/12/2012 VM Unknown AU Oral powder QJ01AA03 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Chlortetracycline hydrochloride Prescription Only Medicine Cattle Antibacterial VPA10810/027/001 VPA10810/027/001 Soluclin 25 mg/ml oral solution for cats and dogs CP-Pharma Handelsgesellschaft mbH 14/08/2023 VM Unknown AU Oral solution QJ01FF01 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Clindamycin hydrochloride Prescription Only Medicine Cats Dogs Antibacterial VPA10989/072/001 VPA10989/072/001 Soludox 500 mg/g powder for use in drinking water for pigs and chickens Eurovet Animal Health B.V. 09/02/2018 VM Unknown AU Powder for use in drinking water QJ01AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Doxycycline hyclate Prescription Only Medicine Chickens Pigs Antibacterial VPA22622/043/001 VPA22622/043/001 Solupam 5 mg/ml solution for injection for dogs and cats Dechra Regulatory B.V. 29/03/2019 VM AU Solution for injection QN05BA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Diazepam Prescription Only Medicine Cats Dogs Neurological Preparations VPA22664/060/001 VPA22664/060/001 Solvasol Injection Norbrook Laboratories (Ireland) Limited 14/06/2002 VM Unknown AU Suspension for injection QJ01DB01 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Subcutaneous use Cefalexin Sodium Prescription Only Medicine Cattle Dogs Antibacterial VPA10454/031/001 VPA10454/031/001 Solvent for cell associated poultry vaccines Boehringer Ingelheim Vetmedica GmbH 18/11/2005 VM Not marketed AU Solution for injection QV07AB Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Prescription Only Medicine Chickens Immunological - Diluent VPA10516/014/001 VPA10516/014/001 SOMNIPRON 10 mg/ml Solution for injection for horses and cattle Vetpharma Animal Health S.L. 24/03/2016 VM Marketed AU Solution for injection QN05CM90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Detomidine hydrochloride Prescription Only Medicine Cattle Horses Neurological Preparations VPA22622/018/001 VPA22622/018/001 Somulose 400 mg/ml + 25 mg/ml solution for injection Dechra Regulatory B.V. 06/10/2006 VM Unknown AU Solution for injection QN05CB02 Well-established use application (Article 13a of Directive No 2001/82/EC) Intravenous use Secobarbital sodium Cinchocaine Hydrochloride Prescription Only Medicine Cats Cattle Dogs Horse (non-food producing) Neurological Preparations VPA10539/007/001 VPA10539/007/001 Spasmalgan compositum 500 mg/ml + 4 mg/ml Solution for injection for horses, cattle, pigs and dogs Veyx-Pharma GmbH 29/05/2020 VM Unknown AU Solution for injection QA03DB04 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Metamizole sodium monohydrate Hyoscine butylbromide Prescription Only Medicine Cattle Dogs Horses Pigs Spasmolytic VPA23462/010/001 VPA23462/010/001 Spasmipur 20 mg/ml solution for injection VetViva Richter GmbH 10/05/2019 VM AU Solution for injection QA03BB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Hyoscine butylbromide Prescription Only Medicine Cattle Horses Pigs Sheep Spasmolytic VPA23462/006/001 VPA23462/006/001 Spasmium comp. 500 mg/ml + 4 mg/ml solution for injection VetViva Richter GmbH 18/09/2015 VM Unknown AU Solution for injection QA03DB04 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Metamizole sodium monohydrate Hyoscine butylbromide Prescription Only Medicine Cattle Dogs Horses Pigs Spasmolytic VPA10815/060/001 VPA10815/060/001 Spectam Injectable 10 % w/v Ceva Santé Animale 01/10/1988 VM Unknown AU Solution for injection QJ01XX04 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Spectinomycin dihydrochloride pentahydrate Prescription Only Medicine Cattle Antibacterial VPA10815/059/001 VPA10815/059/001 Spectam Scour Halt Oral Solution 50 mg/ml Ceva Santé Animale 01/10/1988 VM Unknown AU Oral solution QJ01XX04 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Spectinomycin dihydrochloride pentahydrate Prescription Only Medicine Pigs Sheep Antibacterial VPA10387/065/001 VPA10387/065/001 Spirovac Zoetis Belgium S.A. 28/02/2014 VM Unknown AU Suspension for injection QI02AB03 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Leptospira borgpetersenii, serovar Hardjo, Inactivated Licensed Retailer Cattle Immunological VPA10475/032/002 VPA10475/032/002 Spizobactin 1,500,000 IU/250 mg chewable tablets for dogs Le Vet Beheer B.V. 15/09/2017 VM Unknown AU Chewable tablet QJ51RF01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Spiramycin Metronidazole Prescription Only Medicine Dogs Antibacterial VPA10475/032/003 VPA10475/032/003 Spizobactin 3,000,000 IU/500 mg chewable tablets for dogs Le Vet Beheer B.V. 15/09/2017 VM Unknown AU Chewable tablet QJ51RF01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Spiramycin Metronidazole Prescription Only Medicine Dogs Antibacterial VPA10475/032/001 VPA10475/032/001 Spizobactin 750,000 IU/125 mg chewable tablets for dogs Le Vet Beheer B.V. 15/09/2017 VM Unknown AU Chewable tablet QJ51RF01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Spiramycin Metronidazole Prescription Only Medicine Dogs Antibacterial VPA10475/004/001 VPA10475/004/001 Sporimune 50 mg/ml oral solution for cats and dogs Le Vet Beheer B.V. 19/07/2013 VM Unknown AU Oral solution QL04AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Ciclosporin Prescription Only Medicine Cats Dogs Miscellaneous VPA22664/118/001 VPA22664/118/001 Spotinor 10 mg/ml Spot-on Solution for cattle and sheep Norbrook Laboratories (Ireland) Limited 05/09/2014 VM Unknown AU Spot-on solution QP53AC11 Generic application (Article 13(1) of Directive No 2001/82/EC) Spot-on use Deltamethrin Prescription Only Medicine Cattle Sheep Ectoparasiticide VPA10454/014/001 VPA10454/014/001 Sputolosin Oral Powder 5 mg/g Boehringer Ingelheim Vetmedica GmbH 01/10/1990 VM Unknown AU Oral powder QR05CB90 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Dembrexine hydrochloride monohydrate Prescription Only Medicine Horses Respiratory Tract preparations VPA10988/052/002 VPA10988/052/002 STABOX 500 mg/g Powder for Oral Solution for Pigs Virbac S.A. 23/03/2001 VM Unknown AU Powder for oral solution QJ01CA04 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Amoxicillin Prescription Only Medicine Pigs Antibacterial VPA10988/052/001 VPA10988/052/001 Stabox 5g Premix for medicated feeding stuff Virbac 11/07/1997 VM Unknown AU Premix for medicated feeding stuff QJ01CA04 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Amoxicillin trihydrate Prescription Only Medicine Pigs Antibacterial VPA10387/066/001 VPA10387/066/001 Startect Dual Active Oral Solution for Sheep Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Oral solution QP54AA52 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Derquantel Abamectin Prescription Only Medicine Sheep Endectoparasiticides VPA10782/036/001 VPA10782/036/001 STENOROL CRYPTO 0.5 mg/ml oral solution for calves Huvepharma NV 24/07/2020 VM Unknown AU Oral solution QP51AX08 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Halofuginone Base (As lactate salt) Prescription Only Medicine Cattle Coccidiostats VPA10465/005/001 VPA10465/005/001 Sterofundin Vet Care, solution for infusion for cattle, horses, sheep, goats, pigs, dogs and cats B. Braun Melsungen AG. 17/04/2025 VM Unknown AU Solution for infusion QB05BB01 Bibliographic application (Article 22 of Regulation (EU) 2019/6) Intravenous use Sodium chloride Potassium chloride Magnesium chloride hexahydrate Calcium chloride dihydrate Sodium acetate trihydrate L-malic acid Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Sheep Miscellaneous VPA10396/002/001 VPA10396/002/001 Stimovar Injection lyophilisate and solvent for solution for injection Laboratorios Ovejero S.A.U. 15/06/1993 VM Unknown AU Powder and solvent for solution for infusion QG03GA03 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Equine serum gonadotrophin for veterinary use Prescription Only Medicine Cattle Goats Pigs Sheep Hormone VPA10987/082/001 VPA10987/082/001 Strantel Plus Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 18/12/2009 VM Not marketed AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10987/082/002 VPA10987/082/002 Strantel Plus XL Tablets For Dogs Chanelle Pharmaceuticals Manufacturing Limited 12/04/2013 VM Not marketed AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10810/037/001 VPA10810/037/001 Stresoron 40 mg/ml solution for injection for pigs CP-Pharma Handelsgesellschaft mbH 11/07/2025 VM Unknown AU Solution for injection QN05AD90 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Azaperone Prescription Only Medicine Pigs Neurological Preparations VPA23340/002/001 VPA23340/002/001 Stromease 25 mg/ml eye drops, solution for dogs and cats Domes Pharma 17/06/2022 VM Unknown AU Eye drops, solution QS01XA08 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Ocular use Acetylcysteine Prescription Only Medicine Cats Dogs Miscellaneous VPA22969/002/001 VPA22969/002/001 SUBESTIN 25 microgram/ml oral solution for horses Floris Holding BV 19/08/2022 VM Unknown AU Oral solution QR03CC13 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Clenbuterol hydrochloride Prescription Only Medicine Horses Respiratory Tract preparations VPA10826/021/001 VPA10826/021/001 Suifertil 4 mg/ml oral solution for pigs aniMedica GmbH 16/03/2016 VM Unknown AU Oral solution QG03DX90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Altrenogest Prescription Only Medicine Pigs Hormone VPA10846/019/001 VPA10846/019/001 Suiseng Coli /C Suspension for injection for pigs Laboratorios Hipra S.A. 26/07/2019 VM Marketed AU Suspension for injection QI09AB08 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use F4ab fimbrial adhesin of e.coli F4ac fimbrial adhesin of e.coli F5 fimbrial adhesin of e.coli F6 fimbrial adhesin of e. coli Lt enterotoxoid of e. coli Clostridium perfringens, type C toxoid Clostridium novyi, type B toxoid Licensed Retailer Pigs Immunological VPA10395/001/001 VPA10395/001/001 Suivac APP emulsion for injection for pigs ChemVet dk A/S 14/10/2016 VM Unknown AU Emulsion for injection QI09AB07 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Actinobacillus pleuropneumoniae serotype 2, strain app 2TR98, inactivated APX I toxoid APX II toxoid APX III toxoid Actinobacillus pleuropneumoniae serotype 9, strain app 9KL97, inactivated Prescription Only Exempt Pigs Immunological - Inactivated Vaccine VPA10665/005/001 VPA10665/005/001 Sulfaprex Premix for medicated feeding stuff for pigs LABORATORIOS CALIER S.A. 11/01/2013 VM Not marketed AU Premix for medicated feeding stuff QJ01EW10 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Sulfadiazine Trimethoprim Prescription Only Medicine Pigs Antibacterial VPA10810/034/001 VPA10810/034/001 Sulfequine (333 mg/g + 67 mg/g) oral paste for horse CP-Pharma Handelsgesellschaft mbH 11/07/2025 VM Unknown AU Oral paste QJ01EW10 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Trimethoprim Sulfadiazine Prescription Only Medicine Horses Antibacterial VPA10990/033/001 VPA10990/033/001 Sulfoprim 150 mg/g Premix for medicated feeding stuff Univet Limited 01/05/1998 VM Unknown AU Premix for medicated feeding stuff QJ01EW10 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Trimethoprim Sulfadiazine Prescription Only Medicine Pigs Antibacterial VPA10990/025/001 VPA10990/025/001 Sulfoprim 21% Premix for Medicated Feed Univet Limited 01/10/1989 VM Unknown AU Premix for medicated feeding stuff QJ01EW10 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Trimethoprim Sulfadiazine Prescription Only Medicine Pigs Antibacterial VPA10987/018/001 VPA10987/018/001 Sulpha No.2 Powder for Oral Solution Chanelle Pharmaceuticals Manufacturing Limited 01/10/1988 VM Unknown AU Powder for oral solution QJ01EQ03 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Sulfadimidine Prescription Only Medicine Cattle Antibacterial VPA10555/005/001 VPA10555/005/001 Sulphamet 40/200 Solution for Injection Interchem Ireland Ltd 18/04/2008 VM Unknown AU Solution for injection QJ01EW10 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Trimethoprim Sulfadiazine Prescription Only Medicine Cattle Pigs Antibacterial VPA10987/150/001 VPA10987/150/001 Sumex 1 %w/v solution for injection for cattle Chanelle Pharmaceuticals Manufacturing Limited 28/06/2002 VM Not marketed AU Solution for injection QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/151/001 VPA10987/151/001 Sumex 1% w/v solution for injection for pigs Chanelle Pharmaceuticals Manufacturing Limited 28/06/2002 VM Not marketed AU Solution for injection QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Pigs Endectoparasiticides VPA10987/160/001 VPA10987/160/001 Sumex 5 mg/ml Pour on Solution for Cattle Chanelle Pharmaceuticals Manufacturing Limited 19/01/2007 VM Not marketed AU Pour-on solution QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10203/002/001 VPA10203/002/001 Summer Dip 100 mg/ml Concentrate for dip emulsion for sheep. Hygeia Chemicals Limited 01/10/1989 VM Unknown AU Concentrate for dip emulsion QP53AF03 Well-established use application (Article 13a of Directive No 2001/82/EC) Cutaneous use Dipping Dimpylate Prescription Only Medicine Sheep Ectoparasiticide VPA22020/031/001 VPA22020/031/001 Supaverm Oral Suspension Elanco GmbH 27/04/2012 VM Unknown AU Oral suspension QP52AC09 QP52AG09 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Closantel sodium dihydrate Mebendazole Prescription Only Medicine Sheep Endoparasiticide VPA22664/116/001 VPA22664/116/001 Sureseal 2.6 g Intramammary Suspension for Cattle Norbrook Laboratories (Ireland) Limited 26/07/2013 VM Marketed AU Intramammary suspension QG52X Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Bismuth subnitrate, heavy Licensed Retailer Cattle Miscellaneous VPA22020/032/001 VPA22020/032/001 Surolan Ear Drops and Cutaneous Suspension Elanco GmbH 17/08/2012 VM Unknown AU Cutaneous suspension QD01AC52 Complete application (stand-alone) - Council Directive 81/851/EEC Auricular use Miconazole nitrate Prednisolone acetate Polymyxin b sulfate Prescription Only Medicine Cats Dogs Antifungal VPA10817/004/001 VPA10817/004/001 Surricoxx 400 mg/ml Solution for use in drinking water for chickens, turkeys, ducks and guinea fowls V.M.D. 07/05/2021 VM Unknown AU Solution for use in drinking water QP51AX09 Hybrid application (Article 13(3) of Directive No 2001/82/EC) In drinking water use Amprolium hydrochloride Prescription Only Medicine Chickens Duck Guinea fowl Turkeys Coccidiostats VPA10387/069/001 VPA10387/069/001 Suvaxyn MH-One Emulsion for injection for pigs Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Emulsion for injection QI09AB13 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Mycoplasma hyopneumoniae, inactivated, strain p-5722-3 Licensed Retailer Pigs Immunological - Inactivated Vaccine VPA22622/033/001 VPA22622/033/001 Sympagesic 500 mg/ml + 4 mg/ml solution for injection for horses, cattle, pigs and dogs Dechra Regulatory B.V. 26/06/2019 VM AU Solution for injection QA03DB04 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Metamizole sodium monohydrate Hyoscine butylbromide Prescription Only Medicine Cattle Dogs Horses Pigs Spasmolytic VPA10815/065/001 VPA10815/065/001 Syncroprost, 0.250 mg/ml solution for injection for cattle, horses, pigs and goats Ceva Santé Animale 16/12/2022 VM Unknown AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Cloprostenol sodium Prescription Only Medicine Cattle Goats Horses Pigs Hormone VPA10475/011/002 VPA10475/011/002 Synthadon 10 mg/ml solution for injection for cats and dogs Le Vet Beheer B.V. 10/10/2014 VM Unknown AU Solution for injection QN02AC52 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Methadone hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10387/072/001 VPA10387/072/001 Synulox Bolus 500 mg Zoetis Belgium S.A. 15/08/2014 VM Unknown AU Coated tablet QJ01CR02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cattle Antibacterial VPA10387/073/001 VPA10387/073/001 Synulox Lactating Cow Intramammary suspension Zoetis Belgium S.A. 28/11/2014 VM Unknown AU Intramammary suspension QJ51RV01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use potassium clavulanate Prednisolone Amoxicillin trihydrate Prescription Only Medicine Cattle Antibacterial VPA10387/074/002 VPA10387/074/002 Synulox palatable tablets 200 mg/50 mg Zoetis Belgium S.A. 09/01/2015 VM Unknown AU Tablet QJ01CR02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA10387/074/001 VPA10387/074/001 Synulox palatable tablets 40 mg/10 mg Zoetis Belgium S.A. 09/01/2015 VM Unknown AU Tablet QJ01CR02 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA10387/075/001 VPA10387/075/001 Synulox Ready to Use Injection Zoetis Belgium S.A. 02/05/2014 VM Unknown AU Suspension for injection QJ01CR02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Cattle Dogs Pigs Antibacterial VPA22962/001/001 VPA22962/001/001 SynVet-50; 50 mg solution for injection for horses Equi Pharma Ltd 18/07/2014 VM Marketed AU Solution for injection QM09AX01 Well-established use application (Article 13a of Directive No 2001/82/EC) Intraarticular use Sodium hyaluronate Prescription Only Medicine Horses Miscellaneous VPA10495/011/001 VPA10495/011/001 Syvac Ery Parvo emulsion for injection for pigs Laboratorios Syva S.A. 07/10/2022 VM Unknown AU Emulsion for injection QI09AL01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Porcine parvovirus, strain PVP-7, Inactivated Erysipelothrix rhusiopathiae, serotype 2, Inactivated Prescription Only Medicine Pigs Immunological VPA10989/063/001 VPA10989/063/001 TAF SPRAY 28.5 mg/g Cutaneous Spray, Solution Eurovet Animal Health B.V. 09/01/2015 VM Unknown AU Cutaneous spray, solution QD06AX Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Thiamphenicol Prescription Only Medicine Cattle Goats Horses Mink Pigs Rabbits Sheep Antibacterial VPA10660/004/001 VPA10660/004/001 Taneven LC 3 g intramammary suspension for cattle WDT - Wirtschaftsgenossenschaft deutscher Tierarzte eG, 24/07/2020 VM Unknown AU Intramammary suspension QJ51CE09 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramammary use Benzylpenicillin procaine monohydrate Prescription Only Medicine Cattle Antibacterial VPA22664/151/001 VPA22664/151/001 Taurador 10 mg/ml Solution for Injection for cattle, sheep & pigs Norbrook Laboratories (Ireland) Limited 22/11/2024 VM Unknown AU Solution for injection QP54AA03 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Subcutaneous use Doramectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA22664/111/001 VPA22664/111/001 Taurador 5 mg/ml Pour-on Solution for Cattle Norbrook Laboratories (Ireland) Limited 29/11/2013 VM Unknown AU Pour-on solution QP54AA03 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Doramectin Prescription Only Medicine Cattle Endectoparasiticides VPA22664/130/001 VPA22664/130/001 Tauramox 5 mg/ml Pour-On Solution for Cattle Norbrook Laboratories (Ireland) Limited 01/03/2017 VM Unknown AU Pour-on solution QP54AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Moxidectin Prescription Only Medicine Cattle Endectoparasiticides VPA10980/028/001 VPA10980/028/001 Telmitraxx 4mg/ml oral solution for cats Alfasan Nederland B.V. 04/08/2023 VM Unknown AU Oral solution QC09CA07 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Telmisartan Prescription Only Medicine Cats Cardiovascular VPA10475/033/001 VPA10475/033/001 Temprace 0.5 mg/ml solution for injection for dogs and cats Le Vet Beheer B.V. 25/05/2018 VM Unknown AU Solution for injection QN05AA04 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intravenous use Acepromazine maleate Prescription Only Medicine Cats Dogs Neurological Preparations VPA10387/076/001 VPA10387/076/001 Terramycin Aerosol Spray for sheep Zoetis Belgium S.A. 09/12/2013 VM Unknown AU Cutaneous spray, suspension QD06AA03 Full application (Article 12(3) of Directive No 2001/82/EC) Cutaneous use Oxytetracycline hydrochloride Prescription Only Medicine Sheep Antibacterial VPA10990/052/001 VPA10990/052/001 Terrexine DC 250 mg Intramammary Suspension for Dry Cows Univet Limited 05/07/2019 VM Unknown AU Intramammary suspension QJ51DB90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Cefalonium dihydrate Prescription Only Medicine Cattle Antibacterial VPA10990/023/001 VPA10990/023/001 Terrexine LC Intramammary Suspension for lactating cows Univet Limited 01/10/1988 VM Unknown AU Intramammary suspension QJ51RD01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramammary use Cefalexin monohydrate Kanamycin monosulphate Prescription Only Medicine Cattle Antibacterial VPA10996/150/001 VPA10996/150/001 Tetanus Antitoxin Behring Intervet Ireland Limited 09/04/2003 VM Unknown AU Solution for injection QI04AM02 QI05AM01 QI07AM Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intrathecal use Intravenous use Subcutaneous use Equine serum protein Prescription Only Medicine Dogs Horses Sheep Immunological- Antiserum VPA22033/068/001 VPA22033/068/001 Tetracure 200 mg/ml solution for injection for cattle, sheep and pigs Bimeda Animal Health Limited 05/02/2016 VM Unknown AU Solution for injection QJ01AA06 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Oxytetracycline dihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22033/032/001 VPA22033/032/001 Tetroxy 10 % Solution for Injection for cattle, sheep and pigs Bimeda Animal Health Limited 03/03/2006 VM Not marketed AU Solution for injection QJ01AA06 Informed consent application (Article 13c of Directive No 2001/82/EC) Intramuscular use Oxytetracycline hydrochloride Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA22033/044/001 VPA22033/044/001 Tetroxy LA 200 mg/ml Solution for Injection Bimeda Animal Health Limited 01/10/1988 VM Unknown AU Solution for injection QJ01AA06 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramuscular use Oxytetracycline Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10815/033/002 VPA10815/033/002 Therios 300 mg palatable tablets for dogs Ceva Santé Animale 16/04/2010 VM Unknown AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin monohydrate Prescription Only Medicine Dogs Antibacterial VPA10815/033/001 VPA10815/033/001 Therios 75 mg Chewable Tablets for Cats Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin Prescription Only Medicine Cats Antibacterial VPA10815/033/003 VPA10815/033/003 Therios 750 mg palatable tablets for dogs Ceva Santé Animale 16/04/2010 VM Unknown AU Tablet QJ01DB01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Cefalexin monohydrate Prescription Only Medicine Dogs Antibacterial VPA10475/006/001 VPA10475/006/001 Thiafeline 2.5 mg Film-coated Tablets for Cats Le Vet Beheer B.V. 13/09/2013 VM Unknown AU Film-coated tablet QH03BB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Thiamazole Prescription Only Medicine Cats Hormone VPA10475/006/002 VPA10475/006/002 Thiafeline 5 mg Film-coated Tablets for Cats Le Vet Beheer B.V. 13/09/2013 VM Unknown AU Film-coated tablet QH03BB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Thiamazole Prescription Only Medicine Cats Hormone VPA10989/060/001 VPA10989/060/001 Thyforon flavoured 200 microgram tablets for dogs Eurovet Animal Health B.V. 11/11/2011 VM Marketed AU Tablet QH03AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10989/060/002 VPA10989/060/002 Thyforon flavoured 400 microgram tablets for dogs Eurovet Animal Health B.V. 11/11/2011 VM Marketed AU Tablet QH03AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10989/060/003 VPA10989/060/003 Thyforon flavoured 600 microgram tablets for dogs Eurovet Animal Health B.V. 11/11/2011 VM Marketed AU Tablet QH03AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10989/060/004 VPA10989/060/004 Thyforon flavoured 800 microgram tablets for dogs Eurovet Animal Health B.V. 11/11/2011 VM Marketed AU Tablet QH03AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Levothyroxine sodium Prescription Only Medicine Dogs Hormone VPA10810/023/001 VPA10810/023/001 Thyrasol 5 mg/ml, Oral solution for cats CP-Pharma Handelsgesellschaft mbH 23/12/2022 VM Unknown AU Oral solution QH03BB02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Thiamazole Prescription Only Medicine Cats Miscellaneous VPA10810/028/001 VPA10810/028/001 Thyron vet 200 µg Tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 08/12/2023 VM Unknown AU Tablet QH03AA01 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA10810/028/002 VPA10810/028/002 Thyron vet 400 µg Tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 08/12/2023 VM Unknown AU Tablet QH03AA01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA10810/028/003 VPA10810/028/003 Thyron vet 600 µg Tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 08/12/2023 VM Unknown AU Tablet QH03AA01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA10810/028/004 VPA10810/028/004 Thyron vet 800 µg Tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 08/12/2023 VM Unknown AU Tablet QH03AA01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA22664/127/001 VPA22664/127/001 Thyronorm 5 mg/ml Oral Solution for Cats Norbrook Laboratories (Ireland) Limited 10/06/2016 VM Unknown AU Oral solution QH03BB02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Thiamazole Prescription Only Medicine Cats Hormone VPA10810/029/001 VPA10810/029/001 Thyrotab 200 µg Tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 08/12/2023 VM Unknown AU Tablet QH03AA01 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA10810/029/002 VPA10810/029/002 Thyrotab 400 µg Tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 08/12/2023 VM Unknown AU Tablet QH03AA01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA10810/029/003 VPA10810/029/003 Thyrotab 600 µg Tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 08/12/2023 VM Unknown AU Tablet QH03AA01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA10810/029/004 VPA10810/029/004 Thyrotab 800 µg Tablets for dogs and cats CP-Pharma Handelsgesellschaft mbH 08/12/2023 VM Unknown AU Tablet QH03AA01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA10475/023/001 VPA10475/023/001 Thyroxanil 200 microgram tablets for dogs and cats Le Vet Beheer B.V. 24/06/2016 VM Unknown AU Tablet QH03AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA10475/023/002 VPA10475/023/002 Thyroxanil 600 microgram tablets for dogs and cats Le Vet Beheer B.V. 24/06/2016 VM Unknown AU Tablet QH03AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Levothyroxine sodium Prescription Only Medicine Cats Dogs Hormone VPA22622/019/001 VPA22622/019/001 Tialin 125 mg/ml solution for use in drinking water for pigs, chickens and turkeys Dechra Regulatory B.V. 20/07/2018 VM Unknown AU Solution for use in drinking water QJ01XQ01 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Tiamulin hydrogen fumarate Prescription Only Medicine Chickens Pigs Turkeys Antibacterial VPA22622/019/002 VPA22622/019/002 Tialin 250 mg/ml solution for use in drinking water for pigs, chickens and turkeys Dechra Regulatory B.V. 20/07/2018 VM Unknown AU Solution for use in drinking water QJ01XQ01 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Tiamulin hydrogen fumarate Prescription Only Medicine Chickens Pigs Turkeys Antibacterial VPA10534/002/001 VPA10534/002/001 Tilmodil 300 mg/ml Solution for Injection for cattle and sheep Emdoka 21/04/2011 VM Unknown AU Solution for injection QJ01FA91 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Tilmicosin Prescription Only Medicine Cattle Sheep Antibacterial VPA10782/004/002 VPA10782/004/002 Tilmovet 100 g/kg Premix for medicated feeding stuff for pigs and rabbits Huvepharma NV 13/02/2009 VM Unknown AU Premix for medicated feeding stuff QJ01FA91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Tilmicosin Prescription Only Medicine Pigs Rabbits Antibacterial VPA10782/011/001 VPA10782/011/001 Tilmovet 100 mg/g granules for pigs Huvepharma NV 06/11/2009 VM Unknown AU Granules QJ01FA91 Not Currently Available Oral use Tilmicosin Prescription Only Medicine Pigs Antibacterial VPA10782/004/001 VPA10782/004/001 Tilmovet 200 g/kg Premix for medicated feeding stuff for pigs and rabbits Huvepharma NV 13/02/2009 VM Unknown AU Premix for medicated feeding stuff QJ01FA91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Tilmicosin Prescription Only Medicine Pigs Rabbits Antibacterial VPA10782/003/001 VPA10782/003/001 Tilmovet 250 mg/ml Concentrate for Oral Solution for pigs, chickens, turkeys and cattle (calves) Huvepharma NV 24/10/2008 VM Unknown AU Oral solution QJ01FA91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Tilmicosin Prescription Only Medicine Cattle Chickens Pigs Turkeys Antibacterial VPA10782/032/001 VPA10782/032/001 Tilmovet 300 mg/ml Solution for Injection for cattle and sheep Huvepharma NV 24/05/2019 VM AU Solution for injection QJ01FA91 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Tilmicosin Prescription Only Medicine Cattle Sheep Antibacterial VPA10782/004/003 VPA10782/004/003 Tilmovet 40 g/kg Premix for medicated feeding stuff for pigs and rabbits Huvepharma NV 13/02/2009 VM Unknown AU Premix for medicated feeding stuff QJ01FA91 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Tilmicosin Prescription Only Medicine Pigs Rabbits Antibacterial VPA22693/012/001 VPA22693/012/001 Tizoval 6 mg/g Premix for medicated feeding stuff for pigs ECO Animal Health Europe Limited 02/05/2008 VM Not marketed AU Premix for medicated feeding stuff QP54AA01 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Pigs Endectoparasiticides VPA10983/019/001 VPA10983/019/001 Tolfedine 40 mg/ml solution for injection for dogs and cats Vetoquinol Ireland Limited 12/08/1993 VM Unknown AU Solution for injection QM01AG02 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Subcutaneous use Tolfenamic acid Prescription Only Medicine Cats Dogs N.S.A.I.D. VPA10983/018/001 VPA10983/018/001 Tolfedine 6 mg tablets Vetoquinol Ireland Limited 12/08/1993 VM Unknown AU Tablet QM01AG02 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Tolfenamic acid Prescription Only Medicine Cats Dogs N.S.A.I.D. VPA10983/018/002 VPA10983/018/002 Tolfedine 60 mg tablets Vetoquinol Ireland Limited 12/08/1993 VM Unknown AU Tablet QM01AG02 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Tolfenamic acid Prescription Only Medicine Dogs N.S.A.I.D. VPA10790/006/001 VPA10790/006/001 TOLFEDOL, 40 mg/ml, solution for injection for cattle, pigs, cats and dogs SP Veterinaria, S.A. 21/08/2015 VM Unknown AU Solution for injection QM01AG02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Tolfenamic acid Prescription Only Medicine Cats Cattle Dogs Pigs N.S.A.I.D. VPA10521/023/001 VPA10521/023/001 Tolfine Vetoquinol S.A. 04/02/2000 VM Unknown AU Solution for injection QM01AG02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Tolfenamic acid Prescription Only Medicine Cattle Pigs N.S.A.I.D. VPA10521/017/001 VPA10521/017/001 Tolfine 80 mg/ml solution for injection for cattle Vetoquinol S.A. 26/08/2022 VM Unknown AU Solution for injection QM01AG02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Tolfenamic acid Prescription Only Medicine Cattle N.S.A.I.D. VPA10774/026/001 VPA10774/026/001 Tolracol 50 mg/ml oral suspension for pigs, cattle and sheep Krka, d.d., Novo mesto 05/12/2014 VM Unknown AU Oral suspension QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Cattle Pigs Sheep Coccidiostats VPA10774/007/002 VPA10774/007/002 Toltarox 50 mg/ml oral suspension for cattle Krka, d.d., Novo mesto 15/11/2013 VM Unknown AU Oral suspension QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Cattle Coccidiostats VPA10774/007/001 VPA10774/007/001 Toltarox 50 mg/ml oral suspension for pigs Krka, d.d., Novo mesto 24/09/2010 VM Unknown AU Oral suspension QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Pigs Coccidiostats VPA10987/080/001 VPA10987/080/001 TOPIMEC 0.8 mg/ml Oral Solution for Sheep Chanelle Pharmaceuticals Manufacturing Limited 17/07/2009 VM Unknown AU Oral solution QP54AA01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA10987/159/001 VPA10987/159/001 Topimec 5 mg/ml Pour-on Solution Chanelle Pharmaceuticals Manufacturing Limited 13/05/2005 VM Marketed AU Pour-on solution QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/157/001 VPA10987/157/001 Topimec Injection 10 mg/ml solution for injection Chanelle Pharmaceuticals Manufacturing Limited 04/02/2005 VM Not marketed AU Solution for injection QP54AA01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Pigs Sheep Endectoparasiticides VPA10987/099/001 VPA10987/099/001 Topimec Super Solution for Injection Chanelle Pharmaceuticals Manufacturing Limited 14/10/2011 VM Unknown AU Solution for injection QP54AA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Clorsulon Prescription Only Medicine Cattle Endectoparasiticides VPA10387/079/001 VPA10387/079/001 Torbugesic 10 mg/ml Solution for Injection Zoetis Belgium S.A. 01/10/2000 VM Unknown AU Solution for injection QN02AF01 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Intravenous use Subcutaneous use Butorphanol tartrate Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA10387/080/001 VPA10387/080/001 Torbuphanol Vet 10 mg/ml solution for injection for injection for horses, dogs and cats Zoetis Belgium S.A. 09/11/2012 VM Not marketed AU Solution for injection QN02AF01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Butorphanol tartrate Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA10475/038/001 VPA10475/038/001 Torphadine 10 mg/ml solution for injection for dogs, cats and horses Le Vet Beheer B.V. 28/10/2016 VM Unknown AU Solution for injection QN02AF01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Butorphanol tartrate Prescription Only Medicine Cats Dogs Horses Neurological Preparations VPA10826/009/001 VPA10826/009/001 Torphasol 10 mg/ml solution for injection for horses aniMedica GmbH 29/10/2010 VM Marketed AU Solution for injection QN02AF01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intravenous use Butorphanol tartrate Prescription Only Medicine Horses Neurological Preparations VPA10996/080/001 VPA10996/080/001 Toxovax Intervet Ireland Limited 18/08/2003 VM Unknown AU Concentrate and solvent for suspension for injection QI04AN01 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Toxoplasma gondii tachyzoites s48 Prescription Only Medicine Sheep Immunological - Live Vaccine VPA22622/039/001 VPA22622/039/001 Tralieve 20 mg chewable tablets for dogs Dechra Regulatory B.V. 06/07/2018 VM Unknown AU Chewable tablet QN02AX02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10475/034/001 VPA10475/034/001 Tralieve 50 mg/ml solution for injection for dogs Le Vet Beheer B.V. 16/03/2018 VM Unknown AU Solution for injection QN02AX02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA22622/039/002 VPA22622/039/002 Tralieve 80 mg chewable tablets for dogs Dechra Regulatory B.V. 06/07/2018 VM Unknown AU Chewable tablet QN02AX02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA23340/003/001 VPA23340/003/001 Tramadog 50 mg/ml solution for injection for dogs Domes Pharma 13/04/2018 VM Unknown AU Solution for injection QN02AX02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA22873/006/001 VPA22873/006/001 TRAMADOG 50 mg tablet for dogs Axience 29/07/2022 VM Unknown AU Tablet QN02AX02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10810/031/004 VPA10810/031/004 Tramatab 120 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 02/02/2024 VM Unknown AU Tablet QN02AX02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10810/031/001 VPA10810/031/001 Tramatab 20 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 02/02/2024 VM Unknown AU Tablet QN02AX02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10810/031/002 VPA10810/031/002 Tramatab 50 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 02/02/2024 VM Unknown AU Tablet QN02AX02 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10810/031/003 VPA10810/031/003 Tramatab 80 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 02/02/2024 VM Unknown AU Tablet QN02AX02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10990/038/002 VPA10990/038/002 Tramazole 100 mg/ml oral suspension for cattle and sheep Univet Limited 09/01/2004 VM Unknown AU Oral suspension QP52AC11 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Albendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10990/038/001 VPA10990/038/001 Tramazole 25 mg/ml oral suspension for cattle and sheep Univet Limited 09/01/2004 VM Unknown AU Oral suspension QP52AC11 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Albendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10980/037/002 VPA10980/037/002 Tramcoat 20 mg film-coated tablets for dogs Alfasan Nederland B.V. 19/01/2024 VM Unknown AU Film-coated tablet QN02AX02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10980/037/003 VPA10980/037/003 Tramcoat 40 mg film-coated tablets for dogs Alfasan Nederland B.V. 19/01/2024 VM Unknown AU Film-coated tablet QN02AX02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10980/037/001 VPA10980/037/001 Tramcoat 8 mg film-coated tablets for dogs Alfasan Nederland B.V. 19/01/2024 VM Unknown AU Film-coated tablet QN02AX02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10980/037/004 VPA10980/037/004 Tramcoat 80 mg film-coated tablets for dogs Alfasan Nederland B.V. 19/01/2024 VM Unknown AU Film-coated tablet QN02AX02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10980/038/001 VPA10980/038/001 Tramsan 20 mg chewable tablets for dogs Alfasan Nederland B.V. 19/01/2024 VM Unknown AU Chewable tablet QN02AX02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10980/038/002 VPA10980/038/002 Tramsan 80 mg chewable tablets for dogs Alfasan Nederland B.V. 19/01/2024 VM Unknown AU Chewable tablet QN02AX02 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10988/112/001 VPA10988/112/001 Tramvetol 50 mg/ml solution for injection for dogs Virbac 30/08/2019 VM Unknown AU Solution for injection QN02AX02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA10988/111/001 VPA10988/111/001 Tramvetol 50 mg tablets for dogs Virbac 30/08/2019 VM Unknown AU Tablet QN02AX02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Tramadol hydrochloride Prescription Only Medicine Dogs Neurological Preparations VPA22969/003/001 VPA22969/003/001 Tranquiline 35 mg/ml Oral Gel for Dogs Floris Holding BV 02/03/2012 VM Unknown AU Oral gel QN05AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Acepromazine maleate Prescription Only Medicine Dogs Neurological Preparations VPA10462/001/001 VPA10462/001/001 Triazole Fluke and Worm Drench Pharvet (Ireland) Limited 01/10/1989 VM Unknown AU Oral suspension QP52AE51 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Levamisole hydrochloride Rafoxanide Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10987/167/001 VPA10987/167/001 Tribamec Duo 50 mg/ml + 1 mg/ml Oral Suspension for Sheep Chanelle Pharmaceuticals Manufacturing Limited 20/01/2023 VM Unknown AU Oral suspension QP54AA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Triclabendazole Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA10987/146/002 VPA10987/146/002 Tribex 100 mg/ml Oral Suspension for Cattle Chanelle Pharmaceuticals Manufacturing Limited 02/10/2000 VM Unknown AU Oral suspension QP52AC01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Triclabendazole Prescription Only Medicine Cattle Endoparasiticide VPA10987/146/001 VPA10987/146/001 Tribex 50 mg/ml Oral Suspension for Sheep Chanelle Pharmaceuticals Manufacturing Limited 02/10/2000 VM Unknown AU Oral suspension QP52AC01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Triclabendazole Prescription Only Medicine Sheep Endoparasiticide VPA10996/286/001 VPA10996/286/001 Tribovax 10 suspension for injection for cattle and sheep Intervet Ireland Limited 10/09/2021 VM Unknown AU Suspension for injection QI02AB01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Clostridium Perfringens Type A, Alfa Toxoid CLOSTRIDIUM PERFRINGENS TYPE B, BETA TOXOID Clostridium Perfringens Type C, Beta Toxoid CLOSTRIDIUM PERFRINGENS TYPE D, EPSILON TOXOID clostridium chauvoei, inactivated Clostridium novyi toxoid Clostridium septicum toxoid Clostridium tetani toxoid Clostridium sordellii toxoid CLOSTRIDIUM HAEMOLYTICUM, TOXOID Licensed Retailer Cattle Sheep Immunological - Inactivated Vaccine VPA10996/260/001 VPA10996/260/001 Tribovax T suspension for injection for cattle Intervet Ireland Limited 14/01/2005 VM Unknown AU Suspension for injection QI02AB01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Clostridium chauvoei, strain 3796, Inactivated C. haemolyticum C. haemolyticum cells C.noyvi B C. noyvi B cells C.septicum CN3204 (3U/ml) C.septicum CN368(7U/ml) C.tetani Licensed Retailer Cattle Immunological - Inactivated Vaccine VPA10804/006/001 VPA10804/006/001 Tricaine Pharmaq 1000 mg/g Powder for Solution for Fish Treatment PHARMAQ AS 08/03/2013 VM Unknown AU Powder for solution for fish treatment QN01AX93 Generic application (Article 13(1) of Directive No 2001/82/EC) Water-borne use Tricaine methane sulfonate Prescription Only Medicine Atlantic salmon Other fish Trout Carp Ornamental fish Seabass Neurological Preparations VPA22715/006/001 VPA22715/006/001 Trichovec lyophilisate and solvent for suspension for injection for cattle Animal Health Distributors Limited 11/04/2025 VM Unknown AU Suspension for injection QI02AP01 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Trichophyton verrucosum, strain Bodin 1902, Live Prescription Only Exempt Cattle Immunological - Live Vaccine VPA10987/059/001 VPA10987/059/001 Triclaben 100 mg/ml oral suspension for Cattle Chanelle Pharmaceuticals Manufacturing Limited 06/12/2002 VM Marketed AU Oral suspension QP52AC Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Triclabendazole Prescription Only Medicine Cattle Endoparasiticide VPA10987/058/001 VPA10987/058/001 Triclaben 50 mg/ml oral suspension for Sheep Chanelle Pharmaceuticals Manufacturing Limited 06/12/2002 VM Not marketed AU Oral suspension QP52AC Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Triclabendazole Prescription Only Medicine Sheep Endoparasiticide VPA10803/002/001 VPA10803/002/001 Trigoderm 5 mg/g + 1 mg/g gel for dogs Dechra Veterinary Products A/S 19/03/2004 VM Unknown AU Gel QD07CC01 Complete application (stand-alone) - Council Directive 81/851/EEC Cutaneous use Fusidic acid Betamethasone valerate Prescription Only Medicine Dogs Antibacterial VPA10810/026/001 VPA10810/026/001 Trilotab 10 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 22/09/2023 VM Unknown AU Chewable tablet QH02CA01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA10810/026/004 VPA10810/026/004 Trilotab 120 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 22/09/2023 VM Unknown AU Chewable tablet QH02CA01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA10810/026/005 VPA10810/026/005 Trilotab 150 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 22/09/2023 VM Unknown AU Chewable tablet QH02CA01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA10810/026/002 VPA10810/026/002 Trilotab 30 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 22/09/2023 VM Unknown AU Chewable tablet QH02CA01 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA10810/026/003 VPA10810/026/003 Trilotab 60 mg chewable tablets for dogs CP-Pharma Handelsgesellschaft mbH 22/09/2023 VM Unknown AU Chewable tablet QH02CA01 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA10521/035/001 VPA10521/035/001 Trimediazine Plain Oral Powder Vetoquinol S.A. 01/10/1988 VM Unknown AU Oral powder QJ01EW10 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Trimethoprim Sulfadiazine Prescription Only Medicine Horses Antibacterial VPA10990/048/001 VPA10990/048/001 Trioxyl 500 mg/g powder for use in drinking water for chickens, turkeys, ducks and pigs Univet Limited 27/01/2017 VM Marketed AU Powder for use in drinking water QJ01CA04 Informed consent application (Article 13c of Directive No 2001/82/EC) In drinking water use Amoxicillin Prescription Only Medicine Chickens Duck Pigs Turkeys Antibacterial VPA10990/010/001 VPA10990/010/001 Trioxyl LA 150mg/ml Suspension for Injection Univet Limited 01/10/1988 VM Unknown AU Suspension for injection QJ01CA04 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Amoxicillin trihydrate Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10990/037/001 VPA10990/037/001 Trippel-Oxy 150 mg/ml solution for injection for cattle, sheep and pigs Univet Limited 01/10/1998 VM Marketed AU Solution for injection QJ01AA06 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Oxytetracycline hydrochloride Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10980/041/001 VPA10980/041/001 Triquest 333 mg/ml + 67 mg/ml oral suspension for horses Alfasan Nederland B.V. 31/05/2024 VM Unknown AU Oral suspension QJ01EW10 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Sulfadiazine Trimethoprim Prescription Only Medicine Horses Antibacterial VPA10810/038/002 VPA10810/038/002 Trisulfin vet 100 mg/500 mg chewable tablet for dogs and cats CP-Pharma Handelsgesellschaft mbH 19/06/2026 VM Unknown AU Chewable tablet QJ01EW10 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Trimethoprim Sulfadiazine Prescription Only Medicine Cats Dogs Antibacterial VPA10810/038/001 VPA10810/038/001 Trisulfin vet 25 mg/125 mg chewable tablet for dogs and cats CP-Pharma Handelsgesellschaft mbH 19/06/2026 VM Unknown AU Chewable tablet QJ01EW10 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Trimethoprim Sulfadiazine Prescription Only Medicine Cats Dogs Antibacterial VPA10987/141/001 VPA10987/141/001 Troscan 100 mg film coated tablet for Dogs Chanelle Pharmaceuticals Manufacturing Limited 10/02/1994 VM Unknown AU Film-coated tablet QP52AX01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Nitroscanate Companion Animal Medicine Dogs Endoparasiticide VPA10987/141/002 VPA10987/141/002 Troscan 500 mg film coated tablet for Dogs Chanelle Pharmaceuticals Manufacturing Limited 01/10/1988 VM Unknown AU Film-coated tablet QP52AX01 Well-established use application (Article 13a of Directive No 2001/82/EC) Oral use Nitroscanate Companion Animal Medicine Dogs Endoparasiticide VPA10534/009/001 VPA10534/009/001 Trovex 1 mg/ml suspension for injection for cattle, horses, pigs, cats and dogs Emdoka 12/11/2021 VM Unknown AU Suspension for injection QH02AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Dexamethasone isonicotinate Prescription Only Medicine Cats Cattle Dogs Horses Pigs Corticosteroid VPA10495/008/001 VPA10495/008/001 TROXXAN 100 mg/ml solution for injection for cattle, pigs and sheep Laboratorios Syva S.A. 14/05/2021 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Tulathromycin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10990/056/001 VPA10990/056/001 TruSeal 2.6 g Intramammary suspension for cattle Univet Limited 06/09/2024 VM Unknown AU Intramammary suspension QG52X Informed Consent application (Article 21 of Regulation (EU) 2019/6) Intramammary use Bismuth subnitrate, heavy Licensed Retailer Cattle Teat Dip/Seal VPA10990/051/001 VPA10990/051/001 Trymox LA 150 mg/ml Suspension for Injection for Cattle, Sheep, Pigs, Dogs and Cats Univet Limited 12/04/2019 VM AU Suspension for injection QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Amoxicillin trihydrate Prescription Only Medicine Cats Cattle Dogs Pigs Sheep Antibacterial VPA23440/001/002 VPA23440/001/002 Tsefalen 1000 mg film-coated tablets for dogs Nextmune Italy S.r.l. 09/11/2012 VM Unknown AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin Prescription Only Medicine Dogs Antibacterial VPA23440/001/003 VPA23440/001/003 Tsefalen 50 mg/ml Powder for Oral Suspension for Dogs up to 20 kg and Cats Nextmune Italy S.r.l. 04/12/2020 VM Unknown AU Powder for oral suspension QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin Prescription Only Medicine Cats Dogs Antibacterial VPA23440/001/001 VPA23440/001/001 Tsefalen 500 mg film-coated tablets for dogs Nextmune Italy S.r.l. 09/11/2012 VM Unknown AU Tablet QJ01DB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Cefalexin Prescription Only Medicine Dogs Antibacterial VPA10526/001/001 VPA10526/001/001 Tuberculin PPD Kit Prionics Lelystad - B.V., 26/11/2010 VM Unknown AU Solution for injection QI02AR01 QI02AR02 Full application (Article 12(3) of Directive No 2001/82/EC) Intradermal use Bovine tuberculin PPD Avian tuberculin PPD Prescription Only Medicine Cattle Immunological VPA10790/011/001 VPA10790/011/001 TUDOMAX, 10 mg/g, powder for use in drinking water/milk SP Veterinaria, S.A. 10/02/2017 VM Unknown AU Oral powder QR05CB02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Bromhexine Prescription Only Medicine Cattle Chickens Duck Pigs Turkeys Respiratory Tract preparations VPA10774/058/001 VPA10774/058/001 Tulaxa 100 mg/ml solution for injection for cattle, pigs and sheep Krka, d.d., Novo mesto 08/02/2019 VM Not marketed AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Tulathromycin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10774/058/002 VPA10774/058/002 Tulaxa 25 mg/ml solution for injection for pigs Krka, d.d., Novo mesto 09/10/2020 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Tulathromycin Prescription Only Medicine Pigs Antibacterial VPA22664/146/001 VPA22664/146/001 Tulieve 100 mg/ml solution for injection for cattle, pigs and sheep Norbrook Laboratories (Ireland) Limited 03/07/2020 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Tulathromycin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10509/022/001 VPA10509/022/001 Tullavis 100 mg/ml solution for injection for cattle, pigs and sheep Industrial Veterinaria S.A. 09/10/2020 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Tulathromycin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10509/021/001 VPA10509/021/001 Tullavis 25 mg/ml solution for injection for pigs Industrial Veterinaria S.A. 09/10/2020 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Tulathromycin Prescription Only Medicine Pigs Antibacterial VPA10774/057/001 VPA10774/057/001 Tuloxxin 100 mg/ml solution for injection for cattle, pigs and sheep Krka, d.d., Novo mesto 08/02/2019 VM Not marketed AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Tulathromycin Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10774/057/002 VPA10774/057/002 Tuloxxin 25 mg/ml solution for injection for pigs Krka, d.d., Novo mesto 13/11/2020 VM Unknown AU Solution for injection QJ01FA94 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Tulathromycin Prescription Only Medicine Pigs Antibacterial VPA10454/078/001 VPA10454/078/001 TUR-3 emulsion for injection for turkeys Boehringer Ingelheim Vetmedica GmbH 21/12/2006 VM Not marketed AU Emulsion for injection QI01CA02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Newcastle disease virus, strain Ulster 2C, Inactivated Avian paramyxovirus 3, strain PMV3, Inactivated Turkey rhinotracheitis virus, strain VCO3, Inactivated Prescription Only Medicine Turkeys Immunological - Inactivated Vaccine VPA10774/072/002 VPA10774/072/002 Twinox 200 mg/50 mg chewable tablets for cats and dogs Krka, d.d., Novo mesto 11/06/2021 VM Unknown AU Chewable tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA10774/072/001 VPA10774/072/001 Twinox 40 mg/10 mg chewable tablets for cats and dogs Krka, d.d., Novo mesto 11/06/2021 VM Unknown AU Chewable tablet QJ01CR02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Cats Dogs Antibacterial VPA10774/072/003 VPA10774/072/003 Twinox 400 mg/100 mg chewable tablets for dogs Krka, d.d., Novo mesto 11/06/2021 VM Unknown AU Chewable tablet QJ01CR02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Amoxicillin trihydrate potassium clavulanate Prescription Only Medicine Dogs Antibacterial VPA22020/033/001 VPA22020/033/001 Tylan 200, 200 mg/ml Solution for Injection Elanco GmbH 01/10/1988 VM Unknown AU Solution for injection QJ01FA90 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Tylosin Prescription Only Medicine Cattle Pigs Antibacterial VPA22020/034/002 VPA22020/034/002 Tylan G250 Premix for medicated feeding stuff Elanco GmbH 14/05/1999 VM Unknown AU Premix for medicated feeding stuff QJ01FA90 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Tylosin phosphate Prescription Only Medicine Pigs Antibacterial VPA22020/034/003 VPA22020/034/003 Tylan G50 Premix for medicated feedingstuff Elanco GmbH 26/11/1999 VM Unknown AU Premix for medicated feeding stuff QJ01FA90 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Tylosin phosphate Prescription Only Medicine Pigs Antibacterial VPA22020/020/001 VPA22020/020/001 Tylan Soluble Powder for Oral Solution Elanco GmbH 01/10/1988 VM Unknown AU Powder for oral solution QJ01FA90 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Tylosin Prescription Only Medicine Cattle Chickens Pigs Turkeys Antibacterial VPA10981/004/001 VPA10981/004/001 Tylo 200 mg/ml solution for injection Kela n.v. 01/10/1988 VM Unknown AU Solution for injection QJ01FA90 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Tylosin tartrate Prescription Only Medicine Cattle Pigs Antibacterial VPA10791/020/001 VPA10791/020/001 Tylogran, 1000 mg/g, granules for use in drinking water/milk for cattle (calves), pigs, chickens and turkeys Dopharma Research B.V. 23/12/2022 VM Unknown AU Powder for use in drinking water/milk QJ01FA90 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Tylosin tartrate Prescription Only Medicine Cattle Chickens Pigs Turkeys Antibacterial VPA10402/007/001 VPA10402/007/001 Tylolab tartrate 200,000 IU/ml solution for injection Labiana Life Sciences, S.A. 22/09/2023 VM Unknown AU Solution for injection QJ01FA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Tylosin tartrate Prescription Only Medicine Cattle Pigs Antibacterial VPA10980/005/001 VPA10980/005/001 Tylosin 200 mg/ml solution for injection for cattle and pigs Alfasan Nederland B.V. 01/10/1988 VM Unknown AU Solution for injection QJ01FA90 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Tylosin tartrate Prescription Only Medicine Cattle Pigs Antibacterial VPA10464/001/001 VPA10464/001/001 TYLOSIN BIOVET JSC 200 mg/ml solution for injection for cattle, sheep, goats and pigs BIOVET Joint Stock Company, 31/05/2013 VM Unknown AU Solution for injection QJ01FA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Tylosin Prescription Only Medicine Cattle Goats Pigs Sheep Antibacterial VPA10983/060/001 VPA10983/060/001 Tylucyl 200 mg/ml solution for injection for cattle and pigs Vetoquinol Ireland Limited 06/05/2016 VM Unknown AU Solution for injection QJ01FA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Tylosin Prescription Only Medicine Cattle Pigs Antibacterial VPA10454/016/001 VPA10454/016/001 Ubrolexin intramammary suspension for lactating dairy cows Boehringer Ingelheim Vetmedica GmbH 26/10/2007 VM Not marketed AU Intramammary suspension QJ51RD01 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramammary use Cefalexin monohydrate Kanamycin monosulphate Prescription Only Medicine Cattle Antibacterial VPA10832/002/001 VPA10832/002/001 Ubropen 600 mg intramammary suspension for lactating cows Vetcare Oy 22/04/2016 VM Marketed AU Intramammary suspension QJ51CE09 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramammary use Benzylpenicillin procaine monohydrate Prescription Only Medicine Cattle Antibacterial VPA10990/049/001 VPA10990/049/001 Ubroseal blue Dry Cow 2.6 g intramammary suspension for cattle Univet Limited 02/02/2018 VM Unknown AU Intramammary suspension QG52X Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramammary use Bismuth subnitrate, heavy Prescription Only Medicine Cattle Miscellaneous VPA10454/001/001 VPA10454/001/001 Ubrostar Red 100 mg/280 mg/100 mg Intramammary Suspension for cattle Boehringer Ingelheim Vetmedica GmbH 23/11/2012 VM Marketed AU Intramammary suspension QJ51RC25 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramammary use Penethamate hydriodide Benethamine penicillin Framycetin sulphate Prescription Only Medicine Cattle Antibacterial VPA10400/003/001 VPA10400/003/001 UISCE-JECT, 100 % v/v, solvent for parenteral use Duggan Veterinary Supplies Limited 15/09/2017 VM Unknown AU Solvent for parenteral use QV07AB Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Water for injections Prescription Only Medicine Cats Cattle Dogs Horses Pigs Sheep Miscellaneous VPA22664/045/001 VPA22664/045/001 Ultrapen LA 300 mg/ml Suspension for Injection Norbrook Laboratories (Ireland) Limited 12/12/1997 VM Unknown AU Suspension for injection QJ01CE09 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Procaine benzylpenicillin Prescription Only Medicine Cattle Pigs Antibacterial VPA10990/003/001 VPA10990/003/001 Unicillin 300 mg/ml Suspension for Injection Univet Limited 01/10/1987 VM Unknown AU Suspension for injection QJ01CE09 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Benzylpenicillin procaine Prescription Only Medicine Cattle Pigs Sheep Antibacterial VPA10794/001/001 VPA10794/001/001 Uniferon 200 mg/ml Solution for Injection for pigs (piglets) Pharmacosmos A/ S 03/03/2006 VM Unknown AU Solution for injection QB03AC Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Iron dextran Licensed Retailer Pigs Vitamins and minerals VPA10516/001/001 VPA10516/001/001 Unisol 100 mg/ml solution for injection for cattle and pigs Vetpharma Animal Health S.L. 06/05/2011 VM Marketed AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cattle Pigs Antibacterial VPA10846/013/001 VPA10846/013/001 UNISTRAIN PRRS lyophilisate and solvent for suspension for injection for pigs Laboratorios Hipra S.A. 01/03/2013 VM Marketed AU Lyophilisate and solvent for suspension for injection QI09AD03 Full application (Article 12(3) of Directive No 2001/82/EC) Intradermal use Intramuscular use Live attenuated prrsv, strain vp-046 bis Prescription Only Medicine Pigs Immunological - Live Vaccine VPA10990/026/001 VPA10990/026/001 Univet Multidose Fluke and Worm Drench Univet Limited 01/10/1989 VM Unknown AU Oral suspension QP52AE51 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Rafoxanide Levamisole hydrochloride Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10987/110/001 VPA10987/110/001 Unomec 5 mg/ml Pour-on Solution for beef and dairy cattle Chanelle Pharmaceuticals Manufacturing Limited 15/05/2015 VM Not marketed AU Pour-on solution QP54AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Endectoparasiticides VPA10987/119/001 VPA10987/119/001 Unomox 1 mg/ml oral solution for sheep Chanelle Pharmaceuticals Manufacturing Limited 25/08/2017 VM Marketed AU Oral solution QP54AB02 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Moxidectin Prescription Only Medicine Sheep Endectoparasiticides VPA10980/029/001 VPA10980/029/001 Uriphex 50 mg/ml oral solution for dogs Alfasan Nederland B.V. 07/07/2023 VM Unknown AU Oral solution QG04BX91 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Phenylpropanolamine hydrochloride Prescription Only Medicine Dogs Miscellaneous VPA10826/024/001 VPA10826/024/001 Utertab 2000 mg intrauterine tablet for cattle aniMedica GmbH 17/08/2018 VM Unknown AU Intrauterine tablet QG51AA02 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intrauterine use Tetracycline hydrochloride Prescription Only Medicine Cattle Antibacterial VPA10836/005/001 VPA10836/005/001 VALEMAS 50 mg/ml solution for injection for cattle, sheep, goats, pigs, dogs and cats. FATRO S.p.A. 07/06/2019 VM AU Solution for injection QJ01MA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Enrofloxacin Prescription Only Medicine Cats Cattle Dogs Goats Pigs Sheep Antibacterial VPA10387/082/001 VPA10387/082/001 VANGUARD 7 Zoetis Belgium S.A. 12/09/2014 VM Unknown AU Lyophilisate and solvent for solution for injection QI07AI02 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Canine distemper virus strain N-CDV (live, attenuated) Canine adenovirus type 2 virus, strain manhattan (live, attenuated) Canine parainfluenza type 5 virus, strain NL-CPI-5 (live, attenuated) Canine parvovirus strain NL-35-D (live, attenuated) Leptospira interrogans, serogroup Canicola, serovar Canicola, strain C51, Inactivated Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain NADL 11403, Inactivated Prescription Only Medicine Dogs Immunological VPA10387/083/001 VPA10387/083/001 Vanguard CPV solution for injection for dogs Zoetis Belgium S.A. 12/09/2014 VM Unknown AU Solution for injection QI07AD01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Live canine parvovirus strain NL-35-D Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10387/084/001 VPA10387/084/001 VANGUARD CPV-L. Zoetis Belgium S.A. 12/09/2014 VM Marketed AU Solution for injection QI07AI05 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Live canine parvovirus strain NL-35-D Leptospira interrogans, serogroup Canicola, serovar Canicola, strain C51, Inactivated Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain NADL 11403, Inactivated Prescription Only Medicine Dogs Immunological - Mixed Vaccine (L & A) VPA10387/085/001 VPA10387/085/001 Vanguard Lepto-ci Zoetis Belgium S.A. 12/09/2014 VM Unknown AU Solution for injection QI07AB01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Leptospira icterohaemorrhagiae inactivated Leptospira interrogans, serogroup Canicola, serovar Canicola, strain C51, Inactivated Prescription Only Medicine Dogs Immunological - Inactivated Vaccine VPA10996/285/001 VPA10996/285/001 Vecoxan 2.5 mg/ml Oral Suspension for lambs and calves Intervet Ireland Limited 04/02/2000 VM Unknown AU Oral suspension QP51AJ03 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Diclazuril Prescription Only Medicine Cattle Sheep Coccidiostats VPA10482/002/001 VPA10482/002/001 Veloxa Chewable Tablets for Dogs LAVET Pharmaceuticals Ltd 18/01/2013 VM Unknown AU Chewable tablet QP52AA51 Not Currently Available Oral use Praziquantel Pyrantel Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10482/003/001 VPA10482/003/001 Veloxa XL Chewable Tablets for Dogs LAVET Pharmaceuticals Ltd 18/01/2013 VM Unknown AU Chewable tablet QP52AA51 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10454/018/001 VPA10454/018/001 Ventipulmin Granules 16 micrograms/gram Boehringer Ingelheim Vetmedica GmbH 01/10/1988 VM Unknown AU Granules QR03CC13 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Clenbuterol hydrochloride Prescription Only Medicine Horses Respiratory Tract preparations VPA10454/019/001 VPA10454/019/001 Ventipulmin Solution for Injection 30 micrograms/ml Boehringer Ingelheim Vetmedica GmbH 01/10/1988 VM Unknown AU Solution for injection QR03CC13 Full application (Article 12(3) of Directive No 2001/82/EC) Intravenous use Clenbuterol hydrochloride Prescription Only Medicine Horses Respiratory Tract preparations VPA10454/020/001 VPA10454/020/001 Ventipulmin Syrup 25 micrograms/ml Boehringer Ingelheim Vetmedica GmbH 01/10/1988 VM Unknown AU Syrup QR03CC13 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Clenbuterol hydrochloride Prescription Only Medicine Horses Respiratory Tract preparations VPA10980/045/001 VPA10980/045/001 Ventiquin 25 microgram/ml oral solution for horses Alfasan Nederland B.V. 02/05/2025 VM Unknown AU Oral solution QR03CC13 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Clenbuterol hydrochloride Prescription Only Medicine Horses Respiratory Tract preparations VPA10387/097/001 VPA10387/097/001 Versican Plus Bb Oral lyophilisate and solvent for oral suspension for dogs Zoetis Belgium S.A. 19/08/2019 VM Unknown AU Lyophilisate and solvent for oral suspension QI07AE01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Bordetella bronchiseptica, live Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10387/098/001 VPA10387/098/001 Versican Plus BbPi IN nasal drops, lyophilisate and solvent for suspension for dogs Zoetis Belgium S.A. 25/08/2020 VM Unknown AU Lyophilisate and solvent for suspension for nasal administration QI07AF01 Full application (Article 12(3) of Directive No 2001/82/EC) Nasal use Bordetella bronchiseptica, live Canine parainfluenza virus, live Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10387/087/001 VPA10387/087/001 Versican Plus P lyophilisate and solvent for suspension for injection for dogs Zoetis Belgium S.A. 10/03/2017 VM Unknown AU Lyophilisate and solvent for suspension for injection QI07AD01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Canine parvovirus, live Prescription Only Medicine Dogs Immunological - Live Vaccine VPA10387/088/001 VPA10387/088/001 Versifel FeLV,suspension for injection for cats Zoetis Belgium S.A. 29/08/2013 VM Unknown AU Suspension for injection QI06AA01 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Inactivated feline leukaemia virus(FeLV) subtypes A, B and C Prescription Only Medicine Cats Immunological - Inactivated Vaccine VPA10387/086/001 VPA10387/086/001 Versiguard Rabies, suspension for injection Zoetis Belgium S.A. 13/11/2015 VM Unknown AU Suspension for injection QI07AA02 Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Subcutaneous use Inactivated rabies virus, strain vnukovo-32 Prescription Only Medicine Cats Cattle Dogs Ferrets Goats Horses Pigs Sheep Immunological - Inactivated Vaccine VPA23340/006/001 VPA23340/006/001 Vetbromide 600 mg tablets for dogs Domes Pharma 22/01/2021 VM Unknown AU Tablet QN03AX91 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Potassium bromide Prescription Only Medicine Dogs Neurological Preparations VPA10665/010/001 VPA10665/010/001 VeteCorH 1000 IU/ml lyophilizate and solvent for solution for injection for cattle, horses, sheep, goats, pigs, cats and dogs LABORATORIOS CALIER S.A. 02/05/2025 VM Unknown AU Lyophilisate and solvent for solution for injection QG03GA01 Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6) Intramuscular use Intravenous use Gonadotrophin, chorionic Prescription Only Medicine Cats Cattle Dogs Goats Horses Pigs Sheep Hormone VPA10665/008/001 VPA10665/008/001 Veteglan 0.075 mg/ml Solution for injection for cows, sows and mares LABORATORIOS CALIER S.A. 01/03/2017 VM Unknown AU Solution for injection QG02AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use D-cloprostenol sodium salt Prescription Only Medicine Cattle Horses Pigs Hormone VPA10810/016/001 VPA10810/016/001 Vetemex 10 mg/ml solution for injection for dogs and cats CP-Pharma Handelsgesellschaft mbH 01/02/2019 VM Unknown AU Solution for injection QA04AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Subcutaneous use Maropitant Prescription Only Medicine Cats Dogs Neurological Preparations VPA10665/003/001 VPA10665/003/001 Veterelin 4 microgram/ml solution for injection for cattle, horses, pigs and rabbits LABORATORIOS CALIER S.A. 19/08/2011 VM Marketed AU Solution for injection QH01CA90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Buserelin acetate Prescription Only Medicine Cattle Horses Pigs Rabbits Hormone VPA10815/028/001 VPA10815/028/001 Vetergesic Multidose, 0.3 mg/ml, solution for injection for dogs and cats Ceva Santé Animale 17/08/2012 VM Unknown AU Solution for injection QN02AE01 Well-established use application (Article 13a of Directive No 2001/82/EC) Intramuscular use Intravenous use Buprenorphine hydrochloride Prescription Only Medicine Cats Dogs Neurological Preparations VPA10988/085/001 VPA10988/085/001 Vetflurane 1000 mg/g Inhalation vapour, liquid Virbac 24/09/2010 VM Unknown AU Inhalation vapour, liquid QN01AB06 Generic application (Article 13(1) of Directive No 2001/82/EC) Inhalation use Isoflurane Prescription Only Medicine Cats Chinchilla Dogs Ferrets Gerbil Guinea pig Hamster Horses Mouse Ornamental birds Rat Reptiles Neurological Preparations VPA22693/014/001 VPA22693/014/001 Vetimec 6 mg/g Premix for medicated feeding stuff for pigs ECO Animal Health Europe Limited 10/04/2015 VM Not marketed AU Premix for medicated feeding stuff QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Ivermectin Prescription Only Medicine Pigs Endectoparasiticides VPA22622/021/001 VPA22622/021/001 Vetivex 1 (9 mg/ml) solution for infusion for cattle, horses, dogs and cats Dechra Regulatory B.V. 09/08/2013 VM Unknown AU Solution for infusion QB05BB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Sodium chloride Prescription Only Medicine Cats Cattle Dogs Horses Electrolytes VPA22622/022/001 VPA22622/022/001 Vetivex 11 (Hartmann's) solution for infusion for cattle, horses, dogs and cats Dechra Regulatory B.V. 09/08/2013 VM Unknown AU Solution for infusion QB05BB01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Sodium (S) - lactate Sodium chloride Potassium chloride Calcium chloride dihydrate Prescription Only Medicine Cats Cattle Dogs Horses Electrolytes VPA10454/022/001 VPA10454/022/001 Vetmedin 0.75 mg/ml solution for injection for dogs Boehringer Ingelheim Vetmedica GmbH 22/08/2014 VM Not marketed AU Solution for injection QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10454/023/001 VPA10454/023/001 Vetmedin 1.25 mg chewable tablets for dogs Boehringer Ingelheim Vetmedica GmbH 05/11/2012 VM Not marketed AU Chewable tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10454/023/005 VPA10454/023/005 Vetmedin 1.5 mg/ml oral solution for dogs Boehringer Ingelheim Vetmedica GmbH 10/03/2025 VM Unknown AU Oral solution QC01CE90 Hybrid application – change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10454/023/004 VPA10454/023/004 Vetmedin 10 mg chewable tablets for dogs Boehringer Ingelheim Vetmedica GmbH 29/11/2013 VM Not marketed AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10454/023/002 VPA10454/023/002 Vetmedin 2.5 mg chewable tablets for dogs Boehringer Ingelheim Vetmedica GmbH 05/11/2012 VM Not marketed AU Chewable tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10454/021/001 VPA10454/021/001 Vetmedin 5 mg capsules Boehringer Ingelheim Vetmedica GmbH 01/10/1999 VM Unknown AU Capsule, hard QC01CE90 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10454/023/003 VPA10454/023/003 Vetmedin 5 mg chewable tablets for dogs Boehringer Ingelheim Vetmedica GmbH 05/11/2012 VM Not marketed AU Chewable tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10454/024/001 VPA10454/024/001 Vetmedin Chew 1.25 mg chewable tablets for dogs. Boehringer Ingelheim Vetmedica GmbH 17/04/2015 VM Unknown AU Chewable tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10454/024/004 VPA10454/024/004 Vetmedin Chew 10 mg chewable tablets for dogs Boehringer Ingelheim Vetmedica GmbH 17/04/2015 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10454/024/002 VPA10454/024/002 Vetmedin Chew 2.5 mg chewable tablets for dogs Boehringer Ingelheim Vetmedica GmbH 17/04/2015 VM Not marketed AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10454/024/003 VPA10454/024/003 Vetmedin Chew 5 mg chewable tablets for dogs Boehringer Ingelheim Vetmedica GmbH 17/04/2015 VM Unknown AU Chewable tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10782/005/002 VPA10782/005/002 Vetmulin 100 g/kg premix for medicated feeding stuff for pigs, chickens, turkeys and rabbits Huvepharma NV 20/02/2009 VM Unknown AU Premix for medicated feeding stuff QJ01XQ01 Not Currently Available Oral use Tiamulin hydrogen fumarate Prescription Only Medicine Chickens Pigs Rabbits Turkeys Antibacterial VPA10782/010/001 VPA10782/010/001 Vetmulin 100 mg/g oral granules for pigs Huvepharma NV 12/02/2010 VM Marketed AU Granules QJ01XQ01 Not Currently Available Oral use Tiamulin hydrogen fumarate Prescription Only Medicine Pigs Antibacterial VPA10782/009/002 VPA10782/009/002 VETMULIN 125 mg/ml Solution for use in drinking water for pigs and chickens Huvepharma NV 04/04/2019 VM AU Solution for use in drinking water QJ01XQ01 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Tiamulin hydrogen fumarate Prescription Only Medicine Chickens Pigs Antibacterial VPA10782/008/001 VPA10782/008/001 VETMULIN 162 mg/ml Solution for Injection for pigs Huvepharma NV 30/10/2009 VM Unknown AU Solution for injection QJ01XQ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Tiamulin Prescription Only Medicine Pigs Antibacterial VPA10782/005/001 VPA10782/005/001 Vetmulin 20 g/kg premix for medicated feeding stuff for pigs, chickens, turkeys and rabbits Huvepharma NV 27/02/2009 VM Unknown AU Premix for medicated feeding stuff QJ01XQ01 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) In-feed use Tiamulin hydrogen fumarate Prescription Only Medicine Chickens Pigs Rabbits Turkeys Antibacterial VPA10782/002/001 VPA10782/002/001 Vetmulin 450 mg/g granules for use in drinking water for pigs, chickens and turkeys Huvepharma NV 20/03/2009 VM Unknown AU Granules QJ01XQ01 Generic application (Article 13(1) of Directive No 2001/82/EC) In drinking water use Oral use Tiamulin hydrogen fumarate Prescription Only Medicine Chickens Pigs Turkeys Antibacterial VPA22664/109/001 VPA22664/109/001 Vetofol 10 mg/ml Emulsion for Injection for Cats and Dogs Norbrook Laboratories (Ireland) Limited 31/08/2012 VM Unknown AU Emulsion for injection QN01AX10 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Propofol Prescription Only Medicine Cats Dogs Neurological Preparations VPA22622/023/001 VPA22622/023/001 Vetoryl 10 mg hard capsules for dogs Dechra Regulatory B.V. 01/10/2010 VM Unknown AU Capsule, hard QH02CA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA22622/023/009 VPA22622/023/009 Vetoryl 120 mg chewable tablets for dogs Dechra Regulatory B.V. 28/06/2024 VM Unknown AU Chewable tablet QH02CA01 Full application - known active substance (Article 8 of Regulation (EU) 2019/6) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA22622/023/004 VPA22622/023/004 Vetoryl 120 mg hard capsules for dogs Dechra Regulatory B.V. 01/10/2010 VM Unknown AU Capsule, hard QH02CA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA22622/023/006 VPA22622/023/006 Vetoryl 20 mg chewable tablets for dogs Dechra Regulatory B.V. 28/06/2024 VM Unknown AU Chewable tablet QH02CA01 Full application - known active substance (Article 8 of Regulation (EU) 2019/6) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA22622/023/010 VPA22622/023/010 Vetoryl 20 mg hard capsules for dogs Dechra Regulatory B.V. 22/11/2024 VM Unknown AU Capsule, hard QH02CA01 Full application - known active substance (Article 8 of Regulation (EU) 2019/6) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA22622/023/007 VPA22622/023/007 Vetoryl 30 mg chewable tablets for dogs Dechra Regulatory B.V. 28/06/2024 VM Unknown AU Chewable tablet QH02CA01 Full application - known active substance (Article 8 of Regulation (EU) 2019/6) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA22622/023/002 VPA22622/023/002 Vetoryl 30 mg hard capsules for dogs Dechra Regulatory B.V. 01/10/2010 VM Unknown AU Capsule, hard QH02CA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA22622/023/005 VPA22622/023/005 Vetoryl 5 mg hard capsules for dogs Dechra Regulatory B.V. 30/04/2021 VM Unknown AU Capsule, hard QH02CA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA22622/023/008 VPA22622/023/008 Vetoryl 60 mg chewable tablets for dogs Dechra Regulatory B.V. 28/06/2024 VM Unknown AU Chewable tablet QH02CA01 Full application - known active substance (Article 8 of Regulation (EU) 2019/6) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA22622/023/003 VPA22622/023/003 Vetoryl 60 mg hard capsules for dogs Dechra Regulatory B.V. 01/10/2010 VM Unknown AU Capsule, hard QH02CA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Trilostane Prescription Only Medicine Dogs Hormone VPA10815/049/001 VPA10815/049/001 Vetrimoxin 50mg/g Premix for medicated feeding stuff for pigs Ceva Santé Animale 08/09/2017 VM Unknown AU Premix for medicated feeding stuff QJ01CA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Amoxicillin Prescription Only Medicine Pigs Antibacterial VPA10539/008/001 VPA10539/008/001 Vey Tosal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats Veyx-Pharma GmbH 22/09/2023 VM Unknown AU Solution for injection QA12CX99 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Butaphosphan (Butafosfan) Cyanocobalamin Prescription Only Medicine Cattle Dogs Horses Vitamins and minerals VPA10996/263/001 VPA10996/263/001 Vidalta 10 mg prolonged-release tablets for cats Intervet Ireland Limited 09/12/2011 VM Marketed AU Tablet QH03BB01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Carbimazole Prescription Only Medicine Cats Hormone VPA10996/263/002 VPA10996/263/002 Vidalta 15 mg prolonged-release tablets for cats Intervet Ireland Limited 09/12/2011 VM Marketed AU Tablet QH03BB01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Carbimazole Prescription Only Medicine Cats Hormone VPA10509/016/001 VPA10509/016/001 Vigophos 100 mg/ml + 0.05 mg/ml solution for injection for cattle, horses and dogs Industrial Veterinaria S.A. 09/03/2018 VM Unknown AU Solution for injection QA12CX99 Generic application (Article 13(1) of Directive No 2001/82/EC) Intravenous use Intramuscular use Subcutaneous use Cyanocobalamin Butaphosphan (Butafosfan) Prescription Only Medicine Cattle Dogs Horses Vitamins and minerals VPA10846/016/001 VPA10846/016/001 VIMCO emulsion for injection for ewes and female goats Laboratorios Hipra S.A. 29/09/2017 VM Marketed AU Emulsion for injection QI03AB Full application (Article 12(3) of Directive No 2001/82/EC) Intramuscular use Staphylococcus aureus SP140 CP8 strain, inactivated, expressing biofilm components Prescription Only Medicine Goats Sheep Immunological - Inactivated Vaccine VPA25326/001/001 VPA25326/001/001 Vimectanin DUO 50 mg/ml + 1 mg/ml oral suspension for sheep Pharma VIM Kft. 08/11/2024 VM Unknown AU Oral suspension QP54AA51 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Triclabendazole Ivermectin Prescription Only Medicine Sheep Endectoparasiticides VPA10988/086/001 VPA10988/086/001 VIRBAGEST 4 mg/ml oral solution for pigs Virbac 28/05/2010 VM Unknown AU Oral solution QG03DX90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Altrenogest Prescription Only Medicine Pigs Hormone VPA10988/105/001 VPA10988/105/001 Virbamec Injectable Solution 10 mg/ml Virbac 07/09/1999 VM Unknown AU Solution for injection QP54AA01 Generic application (Article 13(1) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10988/106/001 VPA10988/106/001 VIRBAMEC Pour-On solution for cattle 5 mg/ml Virbac 15/04/2016 VM Unknown AU Pour-on solution QP54AA01 Informed consent (abridged application) - Council Directive 81/851/EEC Pour-on use Ivermectin Prescription Only Medicine Cattle Endectoparasiticides VPA10988/108/001 VPA10988/108/001 Virbamec Super Solution For Injection Virbac 15/04/2016 VM Unknown AU Solution for injection QP54AA51 Full application (Article 12(3) of Directive No 2001/82/EC) Subcutaneous use Ivermectin Clorsulon Prescription Only Medicine Cattle Endectoparasiticides VPA22033/085/001 VPA22033/085/001 VitaBim B1 100 mg/ml Solution for Injection for Cattle and Sheep Bimeda Animal Health Limited 10/01/2025 VM Unknown AU Solution for injection QA11DA01 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Thiamine hydrochloride Prescription Only Medicine Cattle Sheep Vitamins and minerals VPA22033/047/001 VPA22033/047/001 Vitamin B1 100 mg/ml Solution for Injection Bimeda Animal Health Limited 01/10/1991 VM Unknown AU Solution for injection QA11DA01 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Intravenous use Thiamine hydrochloride Prescription Only Medicine Cattle Sheep Vitamins and minerals VPA22033/048/001 VPA22033/048/001 Vitamin K1 10 mg/ml Solution for Injection Bimeda Animal Health Limited 01/10/1991 VM Unknown AU Solution for injection QB02 Complete application (stand-alone) - Council Directive 81/851/EEC Intramuscular use Intravenous use Subcutaneous use Phytomenadione Prescription Only Medicine Cats Cattle Dogs Horses Pigs Sheep Vitamins and minerals VPA10660/002/002 VPA10660/002/002 Vitofyllin 100 mg film-coated tablets for dogs WDT - Wirtschaftsgenossenschaft deutscher Tierarzte eG, 11/05/2012 VM Unknown AU Film-coated tablet QC04AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Propentofylline Prescription Only Medicine Dogs Cardiovascular VPA10660/002/001 VPA10660/002/001 Vitofyllin 50 mg film-coated tablets for dogs WDT - Wirtschaftsgenossenschaft deutscher Tierarzte eG, 11/05/2012 VM Unknown AU Film-coated tablet QC04AD90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Propentofylline Prescription Only Medicine Dogs Cardiovascular VPA10996/127/002 VPA10996/127/002 Vivitonin 100 mg film-coated tablets Intervet Ireland Limited 21/09/2001 VM Unknown AU Tablet QC04AD90 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Propentofylline Prescription Only Medicine Dogs Cardiovascular VPA10996/127/001 VPA10996/127/001 Vivitonin 50 mg film-coated tablets Intervet Ireland Limited 29/10/1999 VM Unknown AU Film-coated tablet QC04AD90 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Propentofylline Prescription Only Medicine Dogs Cardiovascular VPA23462/018/001 VPA23462/018/001 Vominil 10 mg/ml solution for injection for dogs and cats VetViva Richter GmbH 29/09/2023 VM Unknown AU Solution for injection QA04AD90 Generic application (Article 18 of Regulation (EU) 2019/6) Intravenous use Subcutaneous use Maropitant Prescription Only Medicine Cats Dogs Neurological Preparations VPA10987/090/001 VPA10987/090/001 Voxical Plus Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 02/07/2010 VM Not marketed AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10987/090/002 VPA10987/090/002 Voxical Plus XL Tablets For Dogs Chanelle Pharmaceuticals Manufacturing Limited 12/04/2013 VM Not marketed AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10481/003/001 VPA10481/003/001 Vulketan 2.5 mg/g gel for horses Audevard 01/06/2012 VM Unknown AU Gel QD03AX90 Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Ketanserin tartrate Prescription Only Medicine Horses Miscellaneous VPA10505/003/001 VPA10505/003/001 Wellplus Flavoured tablets for Dogs Divasa-Farmavic S.A., 13/12/2013 VM Unknown AU Tablet QP52AA30 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Febantel Pyrantel embonate Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA10203/001/001 VPA10203/001/001 Winter Dip 100 mg/ml Concentrate for dip emulsion for sheep Hygeia Chemicals Limited 01/10/1989 VM Unknown AU Concentrate for dip emulsion QP53AF03 Well-established use application (Article 13a of Directive No 2001/82/EC) Cutaneous use Dimpylate Prescription Only Medicine Sheep Ectoparasiticide VPA10987/108/001 VPA10987/108/001 Wormaway 230/20 mg Flavoured Film-Coated Tablets for Cats Chanelle Pharmaceuticals Manufacturing Limited 04/07/2013 VM Not marketed AU Film-coated tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pyrantel embonate Praziquantel Companion Animal Medicine Cats Endoparasiticide VPA10987/089/001 VPA10987/089/001 Wormaway Plus Tablets for dogs Chanelle Pharmaceuticals Manufacturing Limited 02/07/2010 VM Not marketed AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA10987/089/002 VPA10987/089/002 Wormaway Plus XL Tablets For Dogs Chanelle Pharmaceuticals Manufacturing Limited 12/04/2013 VM Not marketed AU Tablet QP52AA51 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Praziquantel Pyrantel embonate Febantel Companion Animal Medicine Dogs Endoparasiticide VPA23462/017/001 VPA23462/017/001 Xylamidor VetViva Richter GmbH 14/07/2023 VM Unknown AU Solution for injection QN05CM92 Generic application (Article 18 of Regulation (EU) 2019/6) Intramuscular use Intravenous use Subcutaneous use Xylazine Hydrochloride Prescription Only Medicine Cats Cattle Dogs Horses Neurological Preparations VPA10521/036/001 VPA10521/036/001 Xylapan 20 mg/ml Solution for Injection Vetoquinol S.A. 01/10/2000 VM Unknown AU Solution for injection QN05CM92 Informed consent (abridged application) - Council Directive 81/851/EEC Intramuscular use Intravenous use Subcutaneous use Xylazine Hydrochloride Prescription Only Medicine Cats Cattle Dogs Horses Neurological Preparations VPA10980/020/001 VPA10980/020/001 Xylexx 20 mg/ml solution for injection for cattle, horses, dogs and cats Alfasan Nederland B.V. 07/10/2022 VM Unknown AU Solution for injection QN05CM92 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Subcutaneous use Xylazine Hydrochloride Prescription Only Medicine Cats Cattle Dogs Horses Neurological Preparations VPA22020/027/001 VPA22020/027/001 Young's Vector 12.5 mg/ml Pour-on Solution Elanco GmbH 21/10/2016 VM Unknown AU Pour-on solution QP53AC Full application (Article 12(3) of Directive No 2001/82/EC) Pour-on use Cypermethrin tech. (cis: trans / 80:20) Prescription Only Medicine Sheep Ectoparasiticide VPA22969/001/001 VPA22969/001/001 Z-Itch 40 mg/ml pour-on solution Floris Holding BV 21/06/2013 VM Unknown AU Pour-on solution QP53AC04 Generic application (Article 13(1) of Directive No 2001/82/EC) Cutaneous use Permethrin (80:20) technical Prescription Only Medicine Donkey Horse (non-food producing) Ectoparasiticide VPA10987/060/001 VPA10987/060/001 ZANTEL Chanelle Pharmaceuticals Manufacturing Limited 04/11/2003 VM Not marketed AU Tablet QP52AA51 Fixed combination application (Article 13b of Directive No 2001/82/EC) Oral use Praziquantel Fenbendazole Companion Animal Medicine Dogs Endoparasiticide VPA10987/052/001 VPA10987/052/001 Zantel Cat and Dog Tablets Chanelle Pharmaceuticals Manufacturing Limited 04/05/2001 VM Unknown AU Tablet QP52AA51 QP52AC13 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Praziquantel Fenbendazole Companion Animal Medicine Cats Dogs Endoparasiticide VPA10815/046/001 VPA10815/046/001 Zelys 1.25 mg chewable tablets for dogs Ceva Santé Animale 01/06/2018 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10815/046/003 VPA10815/046/003 Zelys 10 mg chewable tablets for dogs Ceva Santé Animale 01/06/2018 VM Unknown AU Chewable tablet QC01CE90 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA10815/046/002 VPA10815/046/002 Zelys 5 mg chewable tablets for dogs Ceva Santé Animale 01/06/2018 VM Unknown AU Chewable tablet QC01CE90 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Pimobendan Prescription Only Medicine Dogs Cardiovascular VPA25433/001/001 VPA25433/001/001 Zerocit 50 mg tablets for dogs Ashish Life Science Holding B.V. 11/10/2024 VM AU Tablet QP52AA01 Generic application (Article 18 of Regulation (EU) 2019/6) Oral use Praziquantel Companion Animal Medicine Dogs Endoparasiticide VPA10987/017/001 VPA10987/017/001 Zerofen 100 mg/ml Oral Suspension Chanelle Pharmaceuticals Manufacturing Limited 04/01/1991 VM Unknown AU Oral suspension QP52AC13 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Fenbendazole Prescription Only Medicine Cattle Endoparasiticide VPA10987/140/001 VPA10987/140/001 Zerofen 222.2 mg/g Granules. Chanelle Pharmaceuticals Manufacturing Limited 15/03/1996 VM Unknown AU Granules QP52AC13 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Fenbendazole Companion Animal Medicine Cats Dogs Endoparasiticide VPA10987/017/002 VPA10987/017/002 Zerofen 25 mg/ml Oral Suspension Chanelle Pharmaceuticals Manufacturing Limited 05/08/1992 VM Unknown AU Oral suspension QP52AC13 Informed consent application (Article 13c of Directive No 2001/82/EC) Oral use Fenbendazole Prescription Only Medicine Cattle Sheep Endoparasiticide VPA10987/143/001 VPA10987/143/001 Zerofen 4 % Premix for medicated feeding stuff Chanelle Pharmaceuticals Manufacturing Limited 15/03/1996 VM Unknown AU Premix for medicated feeding stuff QP52AC13 Informed consent (abridged application) - Council Directive 81/851/EEC Oral use Fenbendazole Prescription Only Medicine Pigs Endoparasiticide VPA10987/109/001 VPA10987/109/001 Zeromectin 5 mg/ml Pour-on Solution for beef and dairy cattle, sheep and goats Chanelle Pharmaceuticals Manufacturing Limited 22/05/2015 VM Not marketed AU Pour-on solution QP54AA04 Generic application (Article 13(1) of Directive No 2001/82/EC) Pour-on use Eprinomectin Prescription Only Medicine Cattle Goats Sheep Endectoparasiticides VPA10987/093/002 VPA10987/093/002 Zeronil 134 mg Spot-on Solution for medium dogs Chanelle Pharmaceuticals Manufacturing Limited 13/07/2012 VM Not marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10987/093/003 VPA10987/093/003 Zeronil 268 mg Spot-on Solution for large dogs Chanelle Pharmaceuticals Manufacturing Limited 13/07/2012 VM Not marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10987/093/004 VPA10987/093/004 Zeronil 402 mg Spot-on Solution for extra large dogs Chanelle Pharmaceuticals Manufacturing Limited 13/07/2012 VM Not marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10987/094/001 VPA10987/094/001 Zeronil 50 mg Spot-on Solution for cats Chanelle Pharmaceuticals Manufacturing Limited 13/07/2012 VM Not marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Cats Ectoparasiticide VPA10987/093/001 VPA10987/093/001 Zeronil 67 mg Spot-on Solution for small dogs Chanelle Pharmaceuticals Manufacturing Limited 13/07/2012 VM Not marketed AU Spot-on solution QP53AX15 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil Prescription Only Medicine Dogs Ectoparasiticide VPA10987/126/002 VPA10987/126/002 Zeronil Combo 134 mg/120.6 mg Spot-on Solution for Medium Dogs Chanelle Pharmaceuticals Manufacturing Limited 20/04/2018 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10987/126/003 VPA10987/126/003 Zeronil Combo 268 mg/241.2 mg Spot-on Solution for Large Dogs. Chanelle Pharmaceuticals Manufacturing Limited 20/04/2018 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10987/126/004 VPA10987/126/004 Zeronil Combo 402 mg/361.8 mg Spot-on Solution for Extra Large Dogs. Chanelle Pharmaceuticals Manufacturing Limited 20/04/2018 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10987/125/001 VPA10987/125/001 Zeronil Combo 50 mg/60 mg Spot-on Solution for Cats and Ferrets Chanelle Pharmaceuticals Manufacturing Limited 20/04/2018 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Cats Ferrets Ectoparasiticide VPA10987/126/001 VPA10987/126/001 Zeronil Combo 67 mg/60.3 mg Spot-on Solution for Small Dogs Chanelle Pharmaceuticals Manufacturing Limited 20/04/2018 VM Unknown AU Spot-on solution QP53AX65 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Spot-on use Fipronil (S)-Methoprene Prescription Only Medicine Dogs Ectoparasiticide VPA10996/202/002 VPA10996/202/002 Zitac vet 100 mg tablets for dogs Intervet Ireland Limited 27/09/2006 VM Temporarily Not Marketed AU Tablet QA02BA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Cimetidine Prescription Only Medicine Dogs Alimentary Tract Preparation VPA10996/202/003 VPA10996/202/003 Zitac vet 200 mg tablets for dogs Intervet Ireland Limited 27/09/2006 VM Temporarily Not Marketed AU Tablet QA02BA01 Full application (Article 12(3) of Directive No 2001/82/EC) Oral use Cimetidine Prescription Only Medicine Dogs Alimentary Tract Preparation VPA10815/040/002 VPA10815/040/002 Zodon 150 mg chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01FF01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Clindamycin Prescription Only Medicine Dogs Antibacterial VPA10815/038/001 VPA10815/038/001 Zodon 25 mg/ml oral solution for cats and dogs Ceva Santé Animale 22/04/2016 VM Marketed AU Oral solution QJ01FF01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Clindamycin Prescription Only Medicine Cats Dogs Antibacterial VPA10815/040/003 VPA10815/040/003 Zodon 264 mg chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01FF01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Clindamycin Prescription Only Medicine Dogs Antibacterial VPA10815/040/001 VPA10815/040/001 Zodon 88 mg chewable tablets for dogs Ceva Santé Animale 22/04/2016 VM Unknown AU Chewable tablet QJ01FF01 Hybrid application (Article 13(3) of Directive No 2001/82/EC) Oral use Clindamycin Prescription Only Medicine Dogs Antibacterial VPA10988/099/002 VPA10988/099/002 ZOLETIL 100 (50 mg/ml + 50 mg/ml) lyophilisate and solvent for solution for injection for dogs and cats Virbac 15/04/2016 VM Unknown AU Lyophilisate and solvent for solution for injection QN01AX99 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Tiletamine Zolazepam Prescription Only Medicine Cats Dogs Neurological Preparations VPA10988/099/001 VPA10988/099/001 ZOLETIL 50 (25 mg/ml + 25 mg/ml) lyophilisate and solvent for solution for injection for dogs and cats Virbac S.A. 15/04/2016 VM Unknown AU Lyophilisate and solvent for solution for injection QN01AX99 Generic application (Article 13(1) of Directive No 2001/82/EC) Intramuscular use Intravenous use Tiletamine Zolazepam Prescription Only Medicine Cats Dogs Neurological Preparations VPA10665/004/001 VPA10665/004/001 Zuritol 25 mg/ml solution for use in drinking water for chickens LABORATORIOS CALIER S.A. 13/07/2012 VM Unknown AU Oral solution QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Chickens Coccidiostats VPA10665/007/001 VPA10665/007/001 Zuritol 50 mg/ml oral suspension for pigs. LABORATORIOS CALIER S.A. 20/12/2013 VM Not marketed AU Oral suspension QP51AJ01 Generic application (Article 13(1) of Directive No 2001/82/EC) Oral use Toltrazuril Prescription Only Medicine Pigs Coccidiostats