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Veterinary Medicines Authorised/Transfer Pending Products This list was last updated on Wednesday, September 29, 2021 Please Note The contents of the table are believed to be correct at the time of compilation. The HPRA makes no representations or warranties about and disclaim all liability for the content, accuracy, completeness or suitability of the information contained in the table for any purpose whatsoever and the information is made available to the public for information purposes only. Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration 4XLA Post- Ecolab VPA10795/002/ 0.64, 2.64 Teat dip solution - QG52A LM: Licensed - Sodium chlorite Full application - Topical use Milking Deutschland 001 percent Merchant as - Lactic acid (Article 12(3) of Germicidal Teat GmbH weight/volume defined in Directive No Dip Solution relevant national 2001/82/EC) legislation Abacare 1% w/v J. & M. VPA10954/010/ 1 percent Pour-on solution - QP54AA02 POM: - Abamectin Informed - Topical use Pour-On Solutio Veterinary 001 weight/volume Prescription Only consent Services Ltd Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC) Abinex Forte 1 % Bimeda Animal VPA22033/035/ 1 percent Pour-on solution - QP54AA02 POM: - Abamectin Informed - Topical use w/v Pour On Health Limited 001 weight/volume Prescription Only consent Solution Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC) Acecare 2 mg/ml Ecuphar NV VPA10491/009/ 2 Solution for - QN05AA04 VPO: Veterinary - Acepromazine Generic - Intramuscular Solution for 001 milligram(s)/millil injection Practitioner Only maleate application use Injection for itre as defined in (Article 13(1) of - Intravenous Dogs and Cats relevant national Directive No use legislation 2001/82/EC) - Subcutaneous use ACEGON 50 Laboratorios VPA10495/004/ 50 Solution for - QH01CA01 POM: - Gonadorelin Generic - Intramuscular micrograms/ml SYVA, S.A.U 001 microgram(s)/mil injection Prescription Only application use solution for lilitre Medicine as (Article 13(1) of injection for defined in Directive No cattle relevant national 2001/82/EC) legislation Acidum Silicicum Galway HOVR10537/01 . Oral solution LM: Licensed Simplified - Oral use Homoeopathics 8/001 Merchant as Registration of a (Manufacturing) defined in Veterinary Limited relevant national Homeopathic legislation Medicinal Product (Article 16, Directive 2001/82/EC) Acomec 10 ECO Animal VPA22693/024/ 10.0 Solution for - QP54AA01 POM: - Ivermectin Informed - Subcutaneous mg/ml Solution Health Europe 001 milligram(s)/millil injection Prescription Only consent use for Injection Limited itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC) Acomec 5 mg/ml ECO Animal VPA22693/023/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin Informed - Topical use Pour-On Solution Health Europe 001 milligram(s)/millil Prescription Only consent for Cattle Limited itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC) Veterinary Medicines Authorised/Transfer Pending Products Page 1 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Adaxio Shampoo Ceva Santé VPA10815/042/ 20, 20 Shampoo - QD08AC52 POM: - Chlorhexidine Hybrid - Topical use for dogs Animale 001 milligram(s)/millil Prescription Only digluconate application itre Medicine as - Miconazole (Article 13(3) of defined in nitrate Directive No relevant national 2001/82/EC) legislation Adequan 100 Daiichi Sankyo VPA10404/001/ 100 Solution for - QM01AX12 POM: - Polysulphated Full application - Intramuscular mg/ml Solution Altkirch SARL 001 milligram(s)/millil injection Prescription Only glycosaminoglyc (Article 12(3) of use for Injection itre Medicine as an Directive No defined in 2001/82/EC) relevant national legislation Adequan 250 Daiichi Sankyo VPA10404/001/ 250 Solution for - QM01AX12 POM: - Polysulphated Full application - Intraarticular mg/ml Solution Altkirch SARL 002 milligram(s)/millil injection Prescription Only glycosaminoglyc (Article 12(3) of use for Injection itre Medicine as an Directive No defined in 2001/82/EC) relevant national legislation Aderexa 12.5 Krka, d.d., Novo VPA10774/063/ 12.5, 125.0 Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/125 mg mesto 002 mg/tablet Prescription Only oxime application chewable tablets Medicine as - Praziquantel (Article 13(1) of for dogs defined in Directive No weighing at least relevant national 2001/82/EC) 5 kg legislation Aderexa 2.5 Krka, d.d., Novo VPA10774/063/ 2.5, 25.0 Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/25 mg mesto 001 mg/tablet Prescription Only oxime application chewable tablets Medicine as - Praziquantel (Article 13(1) of for small dogs defined in Directive No and puppies relevant national 2001/82/EC) weighing at least legislation 0.5 kg Adocam 1.5 aniMedica VPA10826/020/ 1.5 Oral suspension - QM01AC06 POM: - Meloxicam Generic - Oral use mg/ml oral GmbH 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(1) of dogs defined in Directive No relevant national 2001/82/EC) legislation Adrenacaine Norbrook VPA22664/087/ 50, 0.02 Solution for - QN01BA52 POM: - Procaine Generic - Subcutaneous Solution for Laboratories 001 milligram(s)/millil injection Prescription Only hydrochloride application use Injection for (Ireland) Limited itre Medicine as - Adrenaline (Article 13(1) of Cattle defined in tartrate Directive No relevant national 2001/82/EC) legislation Adrestan 10 mg Dechra VPA22622/003/ 10 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Informed - Oral use hard capsules for Regulatory B.V. 001 capsule Prescription Only consent dogs Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC) Adrestan 30 mg Dechra VPA22622/003/ 30 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Informed - Oral use hard capsules Regulatory B.V. 002 capsule Prescription Only consent Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC) Adrestan 60 mg Dechra VPA22622/003/ 60 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Informed - Oral use hard capsules Regulatory B.V. 003 capsule Prescription Only consent Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC) Veterinary Medicines Authorised/Transfer Pending Products Page 2 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Advantage 100 Elanco GmbH VPA22020/046/ 100 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use Spot-on solution 002 Prescription Only for Dogs Medicine as defined in relevant national legislation Advantage 250 Elanco GmbH VPA22020/046/ 250 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use Spot-on solution 003 Prescription Only for Dogs Medicine as defined in relevant national legislation Advantage 40 Elanco GmbH VPA22020/052/ 40 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Generic - Cutaneous use mg Spot-on 001 Prescription Only application solution for Small Medicine as (Article 13(1) of Cats and Small defined in Directive No Pet Rabbits relevant national 2001/82/EC) legislation Advantage 40 Elanco GmbH VPA22020/045/ 40 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use Spot-on solution 001 Prescription Only for Cats Medicine as defined in relevant national legislation Advantage 40 Elanco GmbH VPA22020/046/ 40 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use Spot-on solution 001 Prescription Only for Dogs Medicine as defined in relevant national legislation Advantage 400 Elanco GmbH VPA22020/047/ 400 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use Spot-on solution 001 Prescription Only for Dogs Medicine as defined in relevant national legislation Advantage 80 Elanco GmbH VPA22020/052/ 80 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Generic - Cutaneous use mg Spot-on 002 Prescription Only application solution for Medicine as (Article 13(1) of Large Cats and defined in Directive No Large Pet relevant national 2001/82/EC) Rabbits legislation Advantage 80 Elanco GmbH VPA22020/045/ 80 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use Spot-on solution 002 Prescription Only for Cats Medicine as defined in relevant national legislation Advantix Spot-on Elanco GmbH VPA22020/048/ 250.0/1250.0 Spot-on solution - QP53AC54 POM: - Imidacloprid Full application - Topical use solution for dogs 003 mg/pipette Prescription Only - Permethrin (Article 12(3) of over 10 kg up to Medicine as Directive No 25 kg defined in 2001/82/EC) relevant national legislation Advantix Spot-on Elanco GmbH VPA22020/048/ 400.0/2000.0 Spot-on solution - QP53AC54 POM: - Imidacloprid Full application - Topical use solution for dogs 004 mg/pipette Prescription Only - Permethrin (Article 12(3) of over 25 kg up to Medicine as Directive No 40 kg defined in 2001/82/EC) relevant national legislation Veterinary Medicines Authorised/Transfer Pending Products Page 3 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal