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 Basis Routes of Holder Number Ingredients Administration Advantix Spot-on Elanco GmbH VPA22020/048/ 100.0/500.0 Spot-on solution - QP53AC54 POM: - Imidacloprid Full application - Topical use solution for dogs 002 mg/pipette Prescription Only - Permethrin (Article 12(3) of over 4 kg up to Medicine as Directive No 10 kg. defined in 2001/82/EC) relevant national legislation

Advantix Spot-on Elanco GmbH VPA22020/048/ 600/3000 Spot-on solution - QP53AC54 POM: - Imidacloprid Fixed - Topical solution for dogs 005 mg/pipette Prescription Only - Permethrin combination over 40 kg up to Medicine as (40/60) application 60 kg defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Advantix Spot-on Elanco GmbH VPA22020/048/ 40.0/200.0 Spot-on solution - QP53AC54 POM: - Imidacloprid Full application - Topical use solution for dogs 001 mg/pipette Prescription Only - Permethrin (Article 12(3) of up to 4 kg Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Agrisept MC Medentech Ltd. VPA10928/001/ 2.5 gram/tablet Tablet - QG52A LM: Licensed - Sodium - Topical use Tabs 2.5 g 001 Merchant as didichloroioscya effervescent defined in nurate tablet for teat relevant national (anhydrous) dip/spray legislation solution Alamycin Norbrook VPA22664/014/ 3.2 percent Cutaneous - QD06AA03 POM: - Oxytetracycline Full application - Topical use Aerosol 3.2 Laboratories 001 weight/volume spray, solution Prescription Only Hydrochloride (Article 12(3) of %w/v Cutaneous (Ireland) Limited Medicine as Directive No Spray, solution defined in 2001/82/EC) relevant national legislation

Alamycin LA 200 Norbrook VPA22664/016/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Full application - Intramuscular mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only dihydrate (Article 12(3) of use for Injection (Ireland) Limited itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Alamycin LA 300 Norbrook VPA22664/039/ 300 Solution for - QJ01AA06 POM: - Oxytetracycline Full application - Intramuscular mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only dihydrate (Article 12(3) of use for Injection (Ireland) Limited itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Albencare with Ancare Ireland VPA10915/006/ 150 Oral suspension - QP52AC11 POM: - Albendazole - Oral use Selenium Oral Ltd. 001 milligram(s)/millil Prescription Only Suspension itre Medicine as defined in relevant national legislation

Albex 10 % Oral Chanelle VPA10987/142/ 10 percent Oral suspension - QP52AC11 POM: - Albendazole - Oral use Suspension Pharmaceuticals 002 weight/volume Prescription Only Manufacturing Medicine as Limited defined in relevant national legislation

Albex 2.5 % Oral Chanelle VPA10987/142/ 2.5 percent Oral suspension - QP52AC11 POM: - Albendazole - Oral use Suspension Pharmaceuticals 001 weight/volume Prescription Only Manufacturing Medicine as Limited defined in relevant national legislation

Albex Gold 200 Chanelle VPA10987/123/ 200 Oral suspension - QP52AC11 POM: - Albendazole Hybrid - Oral use mg/ml oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application suspension for Manufacturing itre Medicine as (Article 13(3) of cattle Limited defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 4 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Albiotic 330 Huvepharma NV VPA10782/028/ 330, 100 Intramammary - QJ51RF03 POM: - Lincomycin Full application - Intramammary mg/100 mg 001 mg/syringe solution Prescription Only hydrochloride (Article 12(3) of use Intramammary Medicine as - Neomycin Directive No Solution defined in sulfate 2001/82/EC) relevant national legislation

Alcide Ecolab VPA10795/003/ 26.4/6.4 Teat dip solution - QG52A LM: Licensed - Lactic acid Full application - Topical use UDDERgold Deutschland 001 milligram(s)/millil Merchant as - Sodium chlorite (Article 12(3) of Platinum GmbH itre defined in Directive No relevant national 2001/82/EC) legislation

Alfacef RTU, 50 Alfasan VPA10980/013/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular mg/ml, Nederland B.V 001 milligram(s)/millil injection Prescription Only application use suspension for itre Medicine as (Article 13(1) of - Subcutaneous injection for defined in Directive No use cattle and pigs relevant national 2001/82/EC) legislation

Alfacycline LA Alfa Med Limited VPA10894/002/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular Solution for 001 milligram(s)/millil injection Prescription Only dihydrate consent use Injection itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

ALFAGLANDIN Alfasan VPA10980/012/ 0.250 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular C 0.250 mg/ml Nederland B.V 001 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle relevant national 2001/82/EC) legislation

Alfamox LA 150 Alfa Med Limited VPA10894/004/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin Informed - Intramuscular mg/ml 001 milligram(s)/millil injection Prescription Only trihydrate consent use Suspension for itre Medicine as application Injection defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Alfapen-Strep Alfa Med Limited VPA10894/003/ 200, 200 Suspension for - QJ01RA01 POM: - Benzylpenicillin Informed - Intramuscular Suspension for 001 milligram(s)/millil injection Prescription Only procaine consent use Injection itre Medicine as - application defined in Dihydrostreptom (Article 13c of relevant national ycin sulphate Directive No legislation 2001/82/EC)

Alfatrim 40/200 Alfa Med Limited VPA10894/005/ 40, 200 Solution for - QJ01EW10 POM: - Trimethoprim Informed - Intramuscular Solution for 001 milligram(s)/millil injection Prescription Only - Sulfadiazine consent use Injection itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

ALFAXAN 10 Jurox (Ireland) VPA22751/001/ 10 Solution for - QN01AX05 VPO: Veterinary - Alfaxalone Full application - Intravenous mg/ml solution Limited 001 milligram(s)/millil injection Practitioner Only (Article 12(3) of use for injection for itre as defined in Directive No dogs and cats relevant national 2001/82/EC) legislation

Alfaxan Jurox (Ireland) VPA22751/003/ 10 Solution for - QN01AX05 VPO: Veterinary - Alfaxalone Generic - Intravenous Multidose 10 Limited 001 milligram(s)/millil injection Practitioner Only application use mg/ml solution itre as defined in (Article 13(1) of for injection for relevant national Directive No dogs and cats legislation 2001/82/EC)

Alfaxan Jurox (Ireland) VPA22751/002/ 10 Solution for - QN01AX05 VPO: Veterinary - Alfaxalone Hybrid - Intravenous Multidose 10 Limited 001 milligram(s)/millil injection Practitioner Only application use mg/ml solution itre as defined in (Article 13(3) of for injection for relevant national Directive No dogs, cats and legislation 2001/82/EC) pet rabbits

Veterinary Medicines Authorised/Transfer Pending Products Page 5 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Alizin 30 mg/ml Virbac S.A. VPA10988/066/ 30 Solution for - QG03XB90 POM: - Aglepristone Full application - Subcutaneous Solution for 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use Injection itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

ALPHA JECT PHARMAQ AS VPA10804/001/ . Emulsion for - QI10AB02 POM: - Aeromonas Full application - Intraperitoneal 3000 Emulsion 001 injection Prescription Only salmonicida (Article 12(3) of use for injection for Medicine as subspecies Directive No Atlantic salmon defined in Salmonicida; AL 2001/82/EC) relevant national 2017 legislation - Listonella anguillarum serotype O1; AL 112 - Listonella anguillarum serotype O2a; AL 104 ALPHA JECT PHARMAQ AS VPA10804/003/ . Emulsion for - QI10AA01 POM: - Formaldehyde Full application - Intraperitoneal micro 1 PD 001 injection Prescription Only inactivated (Article 12(3) of use emulsion for Medicine as culture of salmon Directive No injection for defined in pancreas 2001/82/EC) Atlantic salmon relevant national disease virus legislation inactivated strain al v405

ALPHA JECT PHARMAQ AS VPA10804/005/ . Emulsion for - QI10AL02 POM: - infectious Full application - Intraperitoneal micro 6 emulsion 001 injection Prescription Only pancreatic (Article 12(3) of use for injection for Medicine as necrosis virus, Directive No atlantic salmon defined in inactivated 2001/82/EC) relevant national - Listonella legislation 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 Alphalben 100 ALPHA-VET VPA10391/001/ 100 Oral suspension - QP52AC11 POM: - Albendazole Generic - Oral use mg/ml Oral Állatgyógyászati 001 milligram(s)/millil Prescription Only application Suspension for Kft. itre Medicine as (Article 13(1) of Cattle and defined in Directive No Sheep relevant national 2001/82/EC) legislation

Altidox 500 mg/g Eurovet Animal VPA10989/068/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Hybrid - Oral use powder for use in Health B.V. 001 milligram(s)/gra in drinking water Prescription Only hyclate application drinking water for m Medicine as (Article 13(3) of pigs, chickens defined in Directive No and turkeys relevant national 2001/82/EC) legislation

Altresyn 4 mg/ml Ceva Santé VPA10815/010/ 4 Oral solution - QG03DX90 POM: - Altrenogest Generic - Oral use oral solution for Animale 001 milligram(s)/millil Prescription Only application pigs itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 6 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Aludex 50 g/l Intervet Ireland VPA10996/101/ 50 gram(s)/litre Concentrate for - QP53AD01 POM: - Amitraz Full application - Topical use Concentrate for Limited 001 cutaneous Prescription Only (Article 12(3) of cutaneous solution Medicine as Directive No solution defined in 2001/82/EC) relevant national legislation

Aluspray 4% w/w Vetoquinol VPA10983/020/ 4 percent Cutaneous - QD08AB LM: Licensed - Aluminium Full application - Topical use Cutaneous Ireland Limited 001 weight/weight spray, powder Merchant as powder (Article 12(3) of Spray, Powder defined in Directive No relevant national 2001/82/EC) legislation

Alvebuton 100 V.M.D. n.v. VPA16142/003/ 100 Solution for - QA05AX90 POM: - Menbutone Generic - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, pigs, defined in Directive No use horses, sheep, relevant national 2001/82/EC) goats legislation

Alvegesic vet. 10 V.M.D. n.v. VPA16142/002/ 10 Solution for - QN02AF01 POM: - Butorphanol Generic - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous Horses, Dogs defined in Directive No use and Cats relevant national 2001/82/EC) - Subcutaneous legislation use

Alzane 5 mg/ml, Laboratorios VPA10495/001/ 5 Solution for - QV03AB90 POM: - Atipamezole Generic - Intramuscular solution for SYVA, S.A.U 001 milligram(s)/millil injection Prescription Only hydrochloride application use injection for dogs itre Medicine as (Article 13(1) of and cats defined in Directive No relevant national 2001/82/EC) legislation

Amatib 800 mg/g Krka, d.d., Novo VPA10774/045/ 800 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - Oral use oral powder for mesto 001 milligram(s)/gra in drinking water Prescription Only trihydrate application pigs and m Medicine as (Article 13(1) of chickens defined in Directive No relevant national 2001/82/EC) legislation

Amcofen 12.5 Krka, d.d., Novo VPA10774/059/ 12.5.125.0 Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use mg/125 mg film- mesto 004 mg/tablet tablet Prescription Only oxime application coated tablets for Medicine as - Praziquantel (Article 13(1) of dogs weighing at defined in Directive No least 5 kg relevant national 2001/82/EC) legislation

Amcofen Krka, d.d., Novo VPA10774/059/ 12.5, 125 Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use 12.5/125.0 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

Amcofen 16 Krka, d.d., Novo VPA10774/060/ 16, 40 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/40 mg mesto 002 Prescription Only oxime application chewable tablets Medicine as - Praziquantel (Article 13(1) of for cats weighing defined in Directive No at least 2 kg relevant national 2001/82/EC) legislation

Amcofen 2.5 Krka, d.d., Novo VPA10774/059/ 2.5, 12.5 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

Veterinary Medicines Authorised/Transfer Pending Products Page 7 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Amcofen 2.5 Krka, d.d., Novo VPA10774/059/ 2.5,25 mg/tablet Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use mg/25 mg film- mesto 003 tablet Prescription Only oxime application coated tablets for Medicine as - Praziquantel (Article 13(1) of small dogs and defined in Directive No puppies relevant national 2001/82/EC) weighing at least legislation 0.5 kg Amcofen 4 Krka, d.d., Novo VPA10774/060/ 4, 10 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/10 mg mesto 001 Prescription Only oxime application chewable tablets Medicine as - Praziquantel (Article 13(1) of for small cats defined in Directive No and kittens relevant national 2001/82/EC) weighing at least legislation 0.5 kg Amflee 2.5 Krka, d.d., Novo VPA10774/022/ 2.5 Cutaneous - QP53AX15 POM: - Fipronil Generic, hybrid - Cutaneous use mg/ml cutaneous mesto 001 milligram(s)/millil spray, solution Prescription Only or similar spray, solution itre Medicine as biological for cats and dog defined in application relevant national (Article 13 of legislation Directive No 2001/82/EC) Amflee Combo Krka, d.d., Novo VPA10774/051/ 134, 120.6 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Spot-on use 134 mg/120.6 mesto 002 mg/pipette Merchant as - (S)-methoprene application mg spot-on defined in (Article 13(1) of solution for relevant national Directive No medium dogs legislation 2001/82/EC)

Amflee Combo Krka, d.d., Novo VPA10774/051/ 268, 241.2 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Spot-on use 268 mg/241.2 mesto 003 mg/pipette Merchant as - (S)-methoprene application mg spot-on defined in (Article 13(1) of solution for large relevant national Directive No dogs legislation 2001/82/EC)

Amflee Combo Krka, d.d., Novo VPA10774/051/ 402, 361.8 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Spot-on use 402 mg/361.8 mesto 004 mg/pipette Merchant as - (S)-methoprene application mg spot-on defined in (Article 13(1) of solution for extra relevant national Directive No large dogs legislation 2001/82/EC)

Amflee Combo Krka, d.d., Novo VPA10774/050/ 50, 60 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Spot-on use 50 mg/60 mg mesto 001 mg/pipette Merchant as - (S)-methoprene application spot-on solution defined in (Article 13(1) of for cats relevant national Directive No legislation 2001/82/EC)

Amflee Combo Krka, d.d., Novo VPA10774/051/ 67, 60.3 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Spot-on use 67 mg/60.3 mg mesto 001 mg/pipette Merchant as - (S)-methoprene application spot-on solution defined in (Article 13(1) of for small dogs relevant national Directive No legislation 2001/82/EC)

Amodip 1.25 mg Ceva Santé VPA10815/048/ 1.25 mg/tablet Chewable tablet - QC08CA01 POM: - Amlodipine Full application - Oral use chewable tablets Animale 001 Prescription Only (Article 12(3) of for cats Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Amoxibactin 250 Le Vet Beheer VPA10475/013/ 250 mg/tablet Tablet - QJ01CA04 POM: - Amoxicillin (as - Oral use mg tablets for B.V. 002 Prescription Only amoxicillin dogs Medicine as trihydrate) defined in relevant national legislation

Amoxibactin 50 Le Vet Beheer VPA10475/013/ 50 mg/tablet Tablet - QJ01CA04 POM: - Amoxicillin (as - Oral use mg tablets for B.V. 001 Prescription Only amoxicillin dogs and cats Medicine as trihydrate) defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 8 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Amoxibactin 500 Le Vet Beheer VPA10475/013/ 500 mg/tablet Tablet - QJ01CA04 POM: - Amoxicillin (as - Oral use mg tablets for B.V. 003 Prescription Only amoxicillin dogs Medicine as trihydrate) defined in relevant national legislation

AMOXICILLIN GLOBAL VET VPA10477/002/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - In drinking GLOBAL VET HEALTH SL 001 milligram(s)/gra in drinking water Prescription Only trihydrate application water use HEALTH 500 m Medicine as (Article 13(1) of - Oral use mg/g, powder for defined in Directive No use in drinking relevant national 2001/82/EC) water for legislation chickens, turkeys, ducks and pigs Amoxinsol 50 % Vetoquinol VPA10983/041/ 50 percent Powder for oral - QJ01CA04 POM: - Amoxicillin - Oral use w/w powder for Ireland Limited 001 weight/weight solution Prescription Only trihydrate oral solution Medicine as defined in relevant national legislation

AMOXY Dopharma VPA10791/005/ 697 Oral powder - QJ01CA04 POM: - Amoxicillin Generic - Oral use ACTIVE, 697 Research B.V. 001 milligram(s)/gra Prescription Only application mg/g, oral m Medicine as (Article 13(1) of powder for pigs defined in Directive No and chickens relevant national 2001/82/EC) legislation

Amphen 200 Huvepharma NV VPA10782/034/ 200 Granules for use - QJ01BA90 POM: - Florfenicol Hybrid - In drinking mg/g granules 001 milligram(s)/gra in drinking water Prescription Only application water use for use in m Medicine as (Article 13(3) of drinking water for defined in Directive No pigs relevant national 2001/82/EC) legislation

Ampisol 2g Franklin VPA10976/013/ 2 gram(s) Powder for - QJ01CA01 POM: - Ampicillin (as ZZZ Informed - Intramuscular Pharmaceuticals 001 solution for Prescription Only ampicillin sodium consent use Ltd. injection Medicine as ph.eur.) (abridged - Intravenous defined in application) - use relevant national Council Directive legislation 81/851/EEC

AMPROLINE HUVEPHARMA VPA10453/002/ 400 Solution for use - QP51AX09 POM: - Amprolium (as Hybrid - In drinking 400 mg/mL SA 001 milligram(s)/millil in drinking water Prescription Only hydrochloride) application water use solution for use itre Medicine as (Article 13(3) of in drinking water defined in Directive No for chickens and relevant national 2001/82/EC) turkeys legislation

AMX 10 mg/ml PHARMAQ AS VPA10804/002/ 10 Concentrate for - QP53AC11 POM: - Deltamethrin Full application - Topical use concentrate for 001 milligram(s)/millil solution for fish Prescription Only (Article 12(3) of - Water-borne solution for fish itre treatment Medicine as Directive No use treatment defined in 2001/82/EC) relevant national legislation

Anaemex 200 Ark Animal Care VPA10900/010/ 200 Solution for - QB03AC90 LM: Licensed - Iron dextran Well-established - Intramuscular mg/ml Solution Ltd 001 milligram(s)/millil injection Merchant as use application use for Injection itre defined in (Article 13a of relevant national Directive No legislation 2001/82/EC)

Anaestamine Le Vet Beheer VPA10475/010/ 100 Solution for - QN01AX03 VPO: Veterinary - Ketamine Generic - Intramuscular 100 mg/ml B.V. 001 milligram(s)/millil injection Practitioner Only application use solution for itre as defined in (Article 13(1) of - Intravenous injection relevant national Directive No use legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 9 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Animec 0.8 Chanelle VPA10987/070/ 0.8 Oral solution - QP54AA01 POM: - Ivermectin Hybrid - Oral use mg/ml Oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application Solution for Manufacturing itre Medicine as (Article 13(3) of Sheep Limited defined in Directive No relevant national 2001/82/EC) legislation

Animec 1 % Chanelle VPA10987/147/ 1 percent Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous Solution for Pharmaceuticals 001 weight/volume injection Prescription Only use Injection Manufacturing Medicine as Limited defined in relevant national legislation

Animec 18.7 ECO Animal VPA22693/008/ 18.7 Oral paste - QP54AA01 POM: - Ivermectin Well-established - Oral use mg/g Oral Paste Health Europe 001 milligram(s)/gra Prescription Only use application for Horses Limited m Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Animec 5 mg/ml Chanelle VPA10987/152/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin Generic - Topical use Pour-on Solution Pharmaceuticals 001 milligram(s)/millil Prescription Only application for Cattle Manufacturing itre Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Animec Super Chanelle VPA10987/068/ 10 Solution for - QP54AA51 POM: - Ivermectin Generic - Subcutaneous Solution for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only - Clorsulon application use Injection Manufacturing itre Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Animedazon aniMedica VPA10826/005/ 3.21 gram/spray Cutaneous - QD06AA02 POM: - Generic - Cutaneous use Spray, 2.45 % GmbH 001 container spray, Prescription Only Chlortetracycline application w/w cutaneous suspension Medicine as hydrochloride (Article 13(1) of spray defined in Directive No suspension for relevant national 2001/82/EC) cattle, sheep and legislation pigs Animeloxan, 20 aniMedica VPA10826/025/ 20 Solution for - QM01AC06 POM: - Meloxicam Generic - Intramuscular mg/ml, solution GmbH 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, pigs and defined in Directive No use horses relevant national 2001/82/EC) - Subcutaneous legislation use

Anisec 0.5 % w/v Chanelle VPA10987/158/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin - Topical use Pour-on Solution Pharmaceuticals 001 weight/volume Prescription Only Manufacturing Medicine as Limited defined in relevant national legislation

Anivac VHD Pharmagal Bio VPA10556/001/ minimum 1 PD9 Suspension for - QI08AA01 POM: - Rabbit Full application - Subcutaneous Suspension for s.r.o 001 injection Prescription Only haemorrhagic (Article 12(3) of use injection for Medicine as disease, strain Directive No rabbits defined in RHDV PHB 98 2001/82/EC) relevant national legislation

Anthelmin 230 Krka, d.d., Novo VPA10774/049/ 230/20 mg/tablet Film-coated - QP52AA51 CAM: - Pyrantel Generic - Oral use mg/20 mg film- mesto 001 tablet Companion embonate application coated tablets for Animal Medicine - Praziquantel (Article 13(1) of cats as defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 10 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Anthelmin Plus Krka, d.d., Novo VPA10774/033/ 150, 144, 50 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use Flavour Tablets mesto 001 mg/tablet Companion - Praziquantel application for dogs Animal Medicine - Pyrantel (Article 13(1) of as defined in embonate Directive No relevant national 2001/82/EC) legislation

Anthelmin Plus Krka, d.d., Novo VPA10774/033/ 525, 504, 175 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use XL Tablets for mesto 002 mg/tablet Companion - Pyrantel application dogs Animal Medicine embonate (Article 13(1) of as defined in - Praziquantel Directive No relevant national 2001/82/EC) legislation

Antisedan 5 Orion VPA10664/003/ 5 Solution for - QV03AB90 POM: - Atipamezole Full application - Intramuscular mg/ml solution Corporation 001 milligram(s)/millil injection Prescription Only hydrochloride (Article 12(3) of use for injection itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Anxt-F HomeoPet Pet HOVR23152/00 . Oral solution CAM: - Aconite - Oral use Products Limited 1/001 Companion (aconitum Animal Medicine napellus) as defined in - Avena sativa relevant national - Belladonna legislation (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

API-Bioxal, 886 Chemicals Laif VPA10388/001/ 886 Powder for syrup - QP53AG03 LM: Licensed - Oxalic acid Full application - Topical use mg/g powder for S.P.A 001 milligram(s)/gra Merchant as dihydrate (Article 12(3) of in-hive use m defined in Directive No relevant national 2001/82/EC) legislation

APIGUARD gel Vita Bee Health VPA22752/001/ 25 percent Gel - QP53AX22 LM: Licensed - Thymol - Inhalation use (25% thymol) for Limited 001 Merchant as - Topical use beehive use defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 11 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Apivar 500 mg Veto-Pharma VPA22827/001/ 500 milligram(s) Bee-hive strip - QP53AD01 LM: Licensed - Amitraz Well-established - In-hive use Bee-hive strips SAS 001 Merchant as use application for honey bees defined in (Article 13a of relevant national Directive No legislation 2001/82/EC)

Apivar 500 mg Duggan PVPA10400/001 500 Bee-hive strip - QP53AD01 LM: Licensed - Amitraz - In-hive use Bee-hive strips Veterinary /001 milligram/strip Merchant as for honey bees Supplies Ltd. defined in relevant national legislation

Apovomin 1 Dechra VPA22622/002/ 1 Solution for - QN04BC07 VPO: Veterinary - Apomorphine Full application - Subcutaneous mg/ml solution Regulatory B.V. 002 milligram(s)/millil injection Practitioner Only hydrochloride (Article 12(3) of use for injection for itre as defined in hemihydrate Directive No dogs relevant national 2001/82/EC) legislation

Apovomin 3 Dechra VPA22622/002/ 3 Solution for - QN04BC07 VPO: Veterinary - Apomorphine Generic - Subcutaneous mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for itre as defined in (Article 13(1) of dogs relevant national Directive No legislation 2001/82/EC)

Apralan G200 Elanco GmbH VPA22020/013/ 200 Premix for - QA07AA92 POM: - Apramycin ZZZ Complete - Oral use Premix for 002 gram(s)/kilogra medicated Prescription Only sulfate application medicated m(s) feeding stuff Medicine as (stand-alone) - feeding stuff defined in Council Directive relevant national 81/851/EEC legislation

Apralan Soluble Elanco GmbH VPA22020/010/ 552,000 Powder for use - QA07AA92 POM: - Apramycin Full application - Oral use Powder for use 001 international in drinking Prescription Only (Article 12(3) of in drinking unit(s)/gram water/milk Medicine as Directive No water/milk replacer defined in 2001/82/EC) replacer for pigs, relevant national calves, chickens legislation and rabbits

Apravet 100 g/kg Huvepharma NV VPA10782/013/ 100 Premix for - QJ01GB POM: - Apramycin Generic - Oral use premix for 001 gram(s)/kilogra medicated Prescription Only sulphate application medicated m(s) feeding stuff Medicine as (Article 13(1) of feeding stuff for defined in Directive No pigs relevant national 2001/82/EC) legislation

Apravet 552 Huvepharma NV VPA10782/024/ 552 international Powder for use - QA07AA92 POM: - Apramycin Generic - In drinking IU/mg powder for 001 unit(s)/milligram in drinking Prescription Only application water/milk use use in drinking water/milk Medicine as (Article 13(1) of water/milk for defined in Directive No pigs, calves, relevant national 2001/82/EC) chickens and legislation rabbits

Aquaprim Univet Limited VPA10990/024/ 200, 40 Solution for - QJ01EW10 POM: - Trimethoprim - Intramuscular Solution for 001 milligram(s)/millil injection Prescription Only - Sulfadiazine use Injection itre Medicine as defined in relevant national legislation

AquaVac ERM Intervet Ireland VPA10996/218/ . Oral emulsion - QI10BB03 POM: - Yersinia ruckeri Full application - Per Oral Oral. Oral Limited 001 Prescription Only cells inactivated (Article 12(3) of emulsion for Medicine as (Hagerman type Directive No rainbow trout defined in 1 stain) 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 12 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration AquaVac ERM. Intervet Ireland VPA10996/214/ . Concentrate for - QI10BB03 POM: - Yersinia ruckeri - ZZZ Immersion Concentrate for Limited 001 dip suspension Prescription Only cells inactivated dip suspension Medicine as (Hagerman type for Rainbow trou defined in 1 stain) relevant national legislation

AQUAVAC PD Intervet Ireland VPA10996/281/ . Emulsion for - QI10AA01 POM: - Salmon Full application - Intraperitoneal emulsion for Limited 001 injection - QI10BA Prescription Only pancreas (Article 12(3) of use injection for Medicine as disease virus Directive No Atlantic salmon defined in (strain F93-125) 2001/82/EC) relevant national inactivated legislation

AquaVac PD3 Intervet Ireland VPA10996/274/ . Emulsion for - QI10AL POM: - Inactivated Full application - Intraperitoneal emulsion for Limited 001 injection Prescription Only salmon pancreas (Article 12(3) of use injection for Medicine as disease virus Directive No Atlantic salmon defined in - Inactivated 2001/82/EC) relevant national aeromonas legislation salmonicida subsp. salmonicida - Inactivated infectious pancreatic necrosis virus

Aqupharm 1 (9 Ecuphar NV VPA10491/010/ 9 Solution for - QB05BB01 POM: - Sodium Generic - Intraperitoneal mg/ml) solution 001 milligram(s)/millil injection/infusion Prescription Only chloride application use for itre Medicine as (Article 13(1) of - Intravenous injection/infusion defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Aqupharm 11 Ecuphar NV VPA10491/011/ 6.0, 0.4, 0.27, Powder for - QB05BB01 POM: - Sodium Generic - Intravenous (Hartmann's) 001 3.2 suspension for Prescription Only chloride application use Solution for milligram(s)/millil fish treatment Medicine as - Potassium (Article 13(1) of Infusion. itre defined in chloride Directive No relevant national - Calcium 2001/82/EC) legislation chloride dihydrate - Sodium lactate

Arentor DC 250 Univet Limited VPA10990/050/ 250 mg/syringe Intramammary - QJ51DB90 POM: - Cefalonium Hybrid - Intramammary mg 001 suspension Prescription Only dihydrate application use Intramammary Medicine as (Article 13(3) of Suspension for defined in Directive No Dry Cows relevant national 2001/82/EC) legislation

ARIXIL vet 20 Vetpharma VPA10516/020/ 20 mg/tablet Film-coated - QC09AA07 POM: - Benazepril Generic - Oral use mg film-coated Animal Health, 002 tablet Prescription Only hydochloride application tablet for dogs S.L. Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

ARIXIL vet 5 mg Vetpharma VPA10516/020/ 5 mg/tablet Film-coated - QC09AA07 POM: - Benazepril Generic - Oral use film-coated tablet Animal Health, 001 tablet Prescription Only hydochloride application for dogs and cat S.L. Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Arrest Oral Ancare Ireland VPA10915/003/ 2.50/3.75 Oral suspension - QP52AC13 POM: - Fenbendazole - Oral use Suspension Ltd. 001 percent - QP52AE01 Prescription Only - Levamisole weight/volume Medicine as hydrochloride defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 13 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Ataxxa 1250 Krka, d.d., Novo VPA10774/034/ 1250, 250 Spot-on solution - QP53AC54 POM: - Permethrin Hybrid - Topical use mg/250 mg spot- mesto 003 mg/pipette Prescription Only - Imidacloprid application on solution for Medicine as (Article 13(3) of dogs over 10 kg defined in Directive No up to 25 kg relevant national 2001/82/EC) legislation

Ataxxa 200 Krka, d.d., Novo VPA10774/034/ 200, 40 Spot-on solution - QP53AC54 POM: - Permethrin Hybrid - Topical use mg/40 mg spot- mesto 001 mg/pipette Prescription Only - Imidacloprid application on solution for Medicine as (Article 13(3) of dogs up to 4 kg defined in Directive No relevant national 2001/82/EC) legislation

Ataxxa 2000 Krka, d.d., Novo VPA10774/034/ 2000, 400 Spot-on solution - QP53AC54 POM: - Permethrin Hybrid - Topical use mg/400 mg spot- mesto 004 mg/pipette Prescription Only - Imidacloprid application on solution for Medicine as (Article 13(3) of dogs over 25 kg defined in Directive No relevant national 2001/82/EC) legislation

Ataxxa 500 Krka, d.d., Novo VPA10774/034/ 500, 100 Spot-on solution - QP53AC54 POM: - Permethrin Hybrid - Topical use mg/100 mg spot- mesto 002 mg/pipette Prescription Only - Imidacloprid application on solution for Medicine as (Article 13(3) of dogs over 4 kg defined in Directive No up to 10 kg relevant national 2001/82/EC) legislation

Atipam, 5.0 Eurovet Animal VPA10989/055/ 5.0 Solution for - QV03AB90 POM: - Atipamezole Generic - Intramuscular mg/ml, solution Health B.V. 001 milligram(s)/millil injection Prescription Only hydrochloride application use for injection for itre Medicine as (Article 13(1) of cats and dogs defined in Directive No relevant national 2001/82/EC) legislation

ATOPICA 10 mg Elanco GmbH VPA22020/016/ 10 Milligrams per Capsule, soft - QL04AA01 POM: - Ciclosporin Full application - Oral use soft capsules for 001 capsule Prescription Only (Article 12(3) of dogs Medicine as Directive No defined in 2001/82/EC) relevant national legislation

ATOPICA 100 Elanco GmbH VPA22020/016/ 100.00 Capsule, soft - QL04AA01 POM: - Ciclosporin Full application - Oral use mg soft capsules 004 Milligrams per Prescription Only (Article 12(3) of for dogs capsule Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Atopica 100 Elanco GmbH VPA22020/013/ 100 Oral solution - QL04A POM: - Ciclosporin Full application - Oral use mg/ml oral 001 milligram(s)/millil Prescription Only (Article 12(3) of solution for cats itre Medicine as Directive No and dogs defined in 2001/82/EC) relevant national legislation

ATOPICA 25 mg Elanco GmbH VPA22020/016/ 25 Milligrams per Capsule, soft - QL04AA01 POM: - Ciclosporin Full application - Oral use soft capsules for 002 capsule Prescription Only (Article 12(3) of dogs Medicine as Directive No defined in 2001/82/EC) relevant national legislation

ATOPICA 50 mg Elanco GmbH VPA22020/016/ 50 Milligrams per Capsule, soft - QL04AA01 POM: - Ciclosporin Full application - Oral use soft capsules for 003 capsule Prescription Only (Article 12(3) of dogs Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 14 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Aurimic ear Richter Pharma VPA10801/007/ 23.0, 5.0, 0.5293 Ear drops, - QS02CA01 POM: - Miconazole Generic - Auricular use drops and AG 001 milligram(s)/millil suspension Prescription Only nitrate application - Cutaneous use cutaneous itre Medicine as - Prednisolone (Article 13(1) of suspension for defined in acetate Directive No dogs and cats relevant national - Polymyxin B 2001/82/EC) legislation sulfate

AURIZON ear Vetoquinol VPA10983/042/ 3/10/0.9 Ear drops, - QS02CA06 POM: - Marbofloxacin - Auricular use drops, Ireland Limited 001 milligram(s)/millil solution Prescription Only - Clotrimazole suspension itre Medicine as - defined in Dexamethasone relevant national legislation

Aurofac Granular Zoetis Belgium VPA10387/001/ 250 Premix for - QJ01AA03 POM: - Generic - Oral use 250 mg/g Premix S.A. 001 milligram(s)/gra medicated Prescription Only Chlortetracycline application for medicated m feeding stuff Medicine as hydrochloride (Article 13(1) of feedingstuff for defined in Directive No pigs and relevant national 2001/82/EC) chickens legislation

Austiofen 100 Chanelle VPA10987/065/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use mg Tablets for Pharmaceuticals 003 Prescription Only application dogs Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Austiofen 20 mg Chanelle VPA10987/065/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for dogs Pharmaceuticals 001 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Austiofen 50 mg Chanelle VPA10987/065/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for dogs Pharmaceuticals 002 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

AVINEW NEO Boehringer VPA10454/027/ . Effervescent - QI01AD06 POM: - Live newcastle Full application - Ocular use effervescent Ingelheim 001 tablet Prescription Only disease virus (Article 12(3) of - Oculonasal use tablet for Vetmedica Medicine as (VG/GA) Directive No - Oral use chickens and GmbH defined in component 2001/82/EC) turkeys relevant national legislation

AviPro Elanco GmbH VPA22020/068/ . Oral lyophilisate - QI01AD04 POM: - Live chicken Full application - Oral use Thymovac 001 Prescription Only anaemia virus (Article 12(3) of Lyophilisate for Medicine as (CAV), strain Directive No use in drinking defined in cux-1 2001/82/EC) water relevant national legislation

Avishield IB GI- GENERA Inc VPA10405/005/ . Lyophilisate for - QI01AD07 POM: - Avian infectious Full application - In drinking 13, lyophilisate 001 oculonasal Prescription Only bronchitis virus, (Article 12(3) of water use for oculonasal suspension/use Medicine as live Directive No - Oculonasal use suspension/use in drinking water defined in 2001/82/EC) - Oral use in drinking water relevant national for chickens legislation

Avishield IB GENERA Inc VPA10405/002/ . Lyophilisate for - QI01AD07 POM: - Avian infectious Full application - Oculonasal use H120, 001 suspension for Prescription Only brochitis virus (Article 12(3) of - Oral use lyophilisate for oculonasal or Medicine as massachusetts Directive No oculonasal spray app defined in serotype strain 2001/82/EC) suspension/use relevant national h-120 in drinking water, legislation for chickens

Veterinary Medicines Authorised/Transfer Pending Products Page 15 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Avishield IBD GENERA Inc VPA10405/004/ . - QI01AD09 POM: - Avian infectious Full application - Oculonasal use INT, lyophilisate 001 Prescription Only bursal disease (Article 12(3) of - Oral use for oculonasal Medicine as virus, live Directive No suspension/use defined in 2001/82/EC) in drinking water, relevant national for chickens legislation

Avishield IBD GENERA Inc VPA10405/006/ . Lyophilisate for - QI01AD09 POM: - Avian infectious Full application - In drinking Plus, 001 use in drinking Prescription Only bursal disease (Article 12(3) of water use lyophilisate for water Medicine as virus, live Directive No use in drinking defined in 2001/82/EC) water, for relevant national chickens legislation

Avishield ND B1, GENERA Inc VPA10405/003/ . Lyophilisate for - QI01AD06 POM: - Newcastle Full application - Oculonasal use lyophilisate for 001 oculonasal Prescription Only disease virus, (Article 12(3) of - Oral use oculonasal suspension, use Medicine as live Directive No suspension/use in drinking water defined in 2001/82/EC) in drinking water relevant national for chickens. legislation

Azaporc 40 Serumwerk VPA1136/002/0 40 Solution for - QN05AD90 POM: - Azaperone Generic - Intramuscular mg/ml solution Bernburg AG 01 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of pigs defined in Directive No relevant national 2001/82/EC) legislation

B. Braun Vet B. Braun VPA10465/003/ 0.600/0.040/0.0 Solution for - QB05BB01 POM: - Sodium Well-established - Intravenous Care Hartmann's Melsungen AG 001 27/0.312 infusion Prescription Only chloride use application use Lactated Ringers grams/100 Medicine as - Potassium (Article 13a of Solution for millilitres defined in chloride Directive No infusion for relevant national - Calcium 2001/82/EC) cattle, horses, legislation Chloride 2 H2O sheep, goats, - Sodium (S) - pigs, dogs and lactate cats

B. Braun Vet B. Braun VPA10465/002/ 7.5 grams/100 Solution for - QB05BB01 POM: - Sodium Well-established - Intravenous Care hypertonic Melsungen AG 001 millilitres infusion Prescription Only chloride use application use NaCl solution Medicine as (Article 13a of (7.5 g/100 ml) defined in Directive No Solution for relevant national 2001/82/EC) infusion for legislation horses, cattle, sheep, goats, pigs, dogs and cats B.V.P. COPPER Ballinskelligs VPA10956/007/ 20, 1 Suspension for - QA12CX POM: - Copper - Intramuscular WITH VITAMIN Vet. Products Lt 001 milligram(s)/millil injection Prescription Only methionate use B12 INJECTION itre Medicine as - Vitamin b12 defined in relevant national legislation

B.V.P. COPPER Ballinskelligs VPA10956/007/ 20, 1 Suspension for - QA12CX LM: Licensed - Copper - Intramuscular WITH VITAMIN Vet. Products Lt 002 milligram(s)/millil injection Merchant as methionate use B12 INJECTION itre defined in - Vitamin b12 relevant national legislation

Bactidiaryl Oral Vetoquinol VPA10983/006/ . Oral powder - QJ01RA90 POM: - Neomycin ZZZ Complete - Oral use Powder Ireland Limited 001 Prescription Only sulfate application Medicine as - Tetracycline (stand-alone) - defined in hydrochloride Council Directive relevant national 81/851/EEC legislation

Baycox 25 Elanco GmbH VPA22020/054/ 25 Solution for use - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml, solution 001 milligram(s)/millil in drinking water Prescription Only application for use in itre Medicine as (Article 13(1) of drinking water for defined in Directive No chickens and relevant national 2001/82/EC) turkeys legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 16 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Baycox Multi 50 Elanco GmbH VPA22020/055/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml oral 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(1) of Cattle, Pigs and defined in Directive No Sheep relevant national 2001/82/EC) legislation

Bayer Dog Tasty Vetoquinol SA VPA10521/013/ 150,144,50 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use Bone 150/144/50 001 mg/tablet Companion - Praziquantel application mg tablets Animal Medicine - Pyrantel (Article 13(1) of as defined in embonate Directive No relevant national 2001/82/EC) legislation

Bayer Dog Tasty Vetoquinol SA VPA10521/013/ 525,504,175 Tablet - QP52AA51 CAM: - Febantel Generic - Oral use Bone XL 002 mg/tablet Companion - Praziquantel application 525/504/175 mg Animal Medicine - Pyrantel (Article 13(1) of tablets as defined in embonate Directive No relevant national 2001/82/EC) legislation

Bayticol 10 Elanco GmbH VPA22020/060/ 10 Pour-on solution - QP53AC05 POM: - Flumethrin Full application - Topical use mg/ml Pour-On 001 milligram(s)/millil Prescription Only (Article 12(3) of Solution itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Baytril 10% Oral Elanco GmbH VPA22020/063/ 10 Oral solution - QJ01MA90 POM: - Enrofloxacin Full application - Oral use Solution 001 milligram(s)/millil Prescription Only (Article 12(3) of itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Baytril 100 Elanco GmbH VPA22020/043/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Full application - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use for Injection itre Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national - Subcutaneous legislation use

Baytril 2.5% Oral Elanco GmbH VPA22020/062/ 2.5 percent Oral solution - QJ01MA90 POM: - Enrofloxacin Full application - Oral use Solution 001 weight/volume Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Baytril 25 mg/ml Elanco GmbH VPA22020/044/ 25 Solution for - QJ01MA90 POM: - Enrofloxacin Full application - Intramuscular solution for 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use injection itre Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national - Subcutaneous legislation use

Baytril 50 mg/ml Elanco GmbH VPA22020/061/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin - Intramuscular Solution for 001 milligram(s)/millil injection Prescription Only use Injection itre Medicine as - Intravenous defined in use relevant national - Subcutaneous legislation use

Baytril Flavour Elanco GmbH VPA22020/065/ 15 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin - Oral use Tablets 15 mg 001 Prescription Only Medicine as defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 17 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Baytril Flavour Elanco GmbH VPA22020/065/ 150 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin - Oral use Tablets 150 mg 003 Prescription Only Medicine as defined in relevant national legislation

Baytril Flavour Elanco GmbH VPA22020/065/ 50 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin - Oral use Tablets 50 mg 002 Prescription Only Medicine as defined in relevant national legislation

Baytril Max 100 Elanco GmbH VPA22020/053/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only application use for Injection for itre Medicine as (Article 13(1) of - Intravenous Cattle and Pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Baytril Piglet Elanco GmbH VPA22020/064/ 5.0 Oral solution - QJ01MA90 POM: - Enrofloxacin - Oral use Doser 0.5% Oral 001 milligram(s)/millil Prescription Only Solution itre Medicine as defined in relevant national legislation

Bayvarol 3.6 mg Elanco GmbH VPA22020/066/ 3.6 Bee-hive strip - QP53AC05 LM: Licensed - Flumethrin Full application - Cutaneous use Bee-Hive Strips 001 milligram/strip Merchant as (85%) (Article 12(3) of for honey bees defined in Directive No relevant national 2001/82/EC) legislation

Beaphar Flea Beaphar B.V. VPA10455/002/ 3.9 Collar - QP53AF03 CAM: - Dimpylate Full application - Topical use Tick Collar for 001 gram(s)/collar Companion (Article 12(3) of Dogs Animal Medicine Directive No as defined in 2001/82/EC) relevant national legislation

Beaphar Flea Beaphar B.V. VPA10455/001/ 2.1 Collar - QP53AF03 CAM: - Dimpylate Full application - Topical use Collar for Cats 001 gram(s)/collar Companion (Article 12(3) of Animal Medicine Directive No as defined in 2001/82/EC) relevant national legislation

Beaphar Beaphar B.V. VPA10455/004/ 0.2 percent Shampoo - QP53AC04 CAM: - Permethrin Full application - Topical use Insecticidal Dog 001 weight/weight Companion (40/60) (Article 12(3) of Shampoo, 0.2% Animal Medicine Directive No w/w as defined in 2001/82/EC) relevant national legislation

Beaphar Pump Beaphar B.V. VPA10455/005/ 1.027, 1.284 Cutaneous - QP53AC51 CAM: - Pyrethrum Full application - Topical use Action Flea 001 percent spray, solution Companion extract (Article 12(3) of Spray, weight/volume Animal Medicine - Piperonyl Directive No Cutaneous as defined in butoxide 2001/82/EC) Spray Solution relevant national legislation

Belavit AD3E, Bela-Pharm VPA10445/006/ 176.47,50.00,10 Solution for - QA11JA LM: Licensed - Retinol Generic - Intramuscular solution for GmbH & Co. KG 001 0.00 injection Merchant as palmitate application use injection for milligram(s)/millil defined in - all-rac-alpha- (Article 13(1) of - Subcutaneous horses, cattle, itre relevant national Tocopheryl Directive No use pigs, and dogs legislation acetate 2001/82/EC) - Cholecalciferol concentrate

Veterinary Medicines Authorised/Transfer Pending Products Page 18 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Benakor 20 mg Le Vet BV VPA10816/005/ 20 mg/tablet Tablet - QC09AA07 POM: - Benazepril - Oral use tablets for dogs 003 Prescription Only hydrochloride Medicine as defined in relevant national legislation

Benakor 5 mg Le Vet BV VPA10816/005/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril - Oral use tablets for dogs 002 Prescription Only hydrochloride Medicine as defined in relevant national legislation

Benazecare Ecuphar NV VPA10491/006/ 20 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use Flavour 20 mg 002 Prescription Only hydrochloride application Tablets for Dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Benazecare Ecuphar NV VPA10491/006/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use Flavour 5 mg 001 Prescription Only hydochloride application Tablets for Dogs Medicine as (Article 13(1) of and Cats defined in Directive No relevant national 2001/82/EC) legislation

Benefortin LAVET VPA10482/001/ 2.5 mg/tablet Tablet - QC09AA07 POM: - Benazepril - Oral use Flavour 2.5 mg Pharmaceuticals 001 Prescription Only hydrochloride tablets for cats Ltd Medicine as and dogs defined in relevant national legislation

Benefortin LAVET VPA10482/001/ 20 mg/tablet Tablet - QC09AA07 POM: - Benazepril - Oral use Flavour 20 mg Pharmaceuticals 003 Prescription Only hydrochloride tablets for dogs Ltd Medicine as defined in relevant national legislation

Benefortin LAVET VPA10482/001/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril - Oral use Flavour 5 mg Pharmaceuticals 002 Prescription Only hydrochloride tablets for cats Ltd Medicine as and dogs defined in relevant national legislation

Betafuse 1 mg/g Norbrook VPA22664/129/ 1, 5 Gel - QD07CC01 POM: - Betamethasone Hybrid - Topical use + 5 mg/g gel for Laboratories 001 milligram(s)/gra Prescription Only valerate application dogs (Ireland) Limited m Medicine as - Fusidic acid (Article 13(3) of defined in hemihydrate Directive No relevant national 2001/82/EC) legislation

Betamox 150 Norbrook VPA22664/004/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin Full application - Intramuscular mg/ml Laboratories 001 milligram(s)/millil injection Prescription Only trihydrate (Article 12(3) of use Suspension for (Ireland) Limited itre Medicine as Directive No - Subcutaneous Injection defined in 2001/82/EC) use relevant national legislation

Betamox LA 150 Norbrook VPA22664/010/ 150 Suspension for - QJ01CA01 POM: - Amoxicillin Full application - Intramuscular mg/ml Laboratories 001 milligram(s)/millil injection Prescription Only trihydrate (Article 12(3) of use Suspension for (Ireland) Limited itre Medicine as Directive No - Subcutaneous Injection defined in 2001/82/EC) use relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 19 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Bexepril 2.5 mg Chanelle VPA10987/074/ 2.5 mg/tablet Film-coated - QC09AA07 POM: - Benazepril Generic - Oral use Film-coated Pharmaceuticals 001 tablet Prescription Only hydrochloride application tablet for dogs Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Bexepril 20 mg Chanelle VPA10987/074/ 20 mg/tablet Film-coated - QC09AA07 POM: - Benazepril Generic - Oral use Film-coated Pharmaceuticals 003 tablet Prescription Only hydrochloride application tablet for dogs Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Bexepril 5 mg Chanelle VPA10987/074/ 5 mg/tablet Film-coated - QC09AA07 POM: - Benazepril Generic, hybrid - Oral use Film-coated Pharmaceuticals 002 tablet Prescription Only hydrochloride or similar tablet for dogs Manufacturing Medicine as biological Limited defined in application relevant national (Article 13 of legislation Directive No 2001/82/EC) Big Cat Wormer Vetoquinol SA VPA10521/010/ 30,345 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel Informed - Oral use Film-Coated 001 Companion - Pyrantel consent Tablets Animal Medicine embonate application as defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Bilosin 200 Bimeda Animal VPA22033/036/ 200 Solution for - QJ01FA90 POM: - Tylosin - Intramuscular mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only use for Injection itre Medicine as defined in relevant national legislation

Bilovet 200 Bimeda Animal VPA22033/055/ 200 Solution for - QJ01FA90 POM: - Tylosin Generic - Intramuscular mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only application use for Injection for itre Medicine as (Article 13(1) of cattle and pigs defined in Directive No relevant national 2001/82/EC) legislation

Bimadine Bimeda Animal VPA22033/037/ 25 g/sachet Powder for oral - QJ01EQ03 POM: - Sulfadimidine Well-established - Oral use Powder for Oral Health Limited 001 suspension Prescription Only use application Suspension Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Bimastat Oral Bimeda Animal VPA22033/001/ 25/150 Oral suspension - QJ01RA02 POM: - Sulfadiazine Full application - Oral use Suspension Health Limited 001 milligram(s)/millil Prescription Only - Neomycin (Article 12(3) of itre Medicine as sulphate Directive No defined in 2001/82/EC) relevant national legislation

Bimectin 0.5% ECO Animal VPA22693/019/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin Informed - Topical use Cattle Pour-on Health Europe 001 Prescription Only consent Solution Limited Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Bimectin 1% w/v Bimeda Animal VPA22033/056/ 1.0 percent Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous Solution for Health Limited 001 weight/volume injection Prescription Only application use Injection Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 20 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Bimectin Horse Bimeda Animal VPA22033/049/ 18.7 Oral paste - QP54AA01 POM: - Ivermectin Generic - Oral use Oral Paste 18.7 Health Limited 001 milligram(s)/gra Prescription Only application mg/g m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Bimectin Plus Bimeda Animal VPA22033/002/ 10/100 Solution for - QP54AA51 POM: - Ivermectin Generic - Subcutaneous Solution for Health Limited 001 milligram(s)/millil injection Prescription Only - Clorsulon application use Injection itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Bimeprine 5 Bimeda Animal VPA22033/057/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Generic - Pour-on use mg/ml pour-on Health Limited 001 milligram(s)/millil Prescription Only application solution for cattle itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Bimotrim Co Bimeda Animal VPA22033/038/ 200, 40 Solution for - QJ01EW13 POM: - Trimethoprim ZZZ --Unknown- - Intramuscular Injection Health Limited 001 milligram(s)/millil injection Prescription Only - Sulfadoxine use itre Medicine as - Intravenous defined in use relevant national legislation

Bimoxyl LA 150 Bimeda Animal VPA22033/039/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin ZZZ Complete - Intramuscular mg/ml Health Limited 001 milligram(s)/millil injection Prescription Only trihydrate application use Suspension for itre Medicine as (stand-alone) - - Subcutaneous Injection defined in Council Directive use relevant national 81/851/EEC legislation

Bimoxyvet LA Laboratorios VPA10436/002/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin Generic - Intramuscular 150 mg/ml, Maymó, S.A. 001 milligram(s)/millil injection Prescription Only trihydrate application use Suspension for itre Medicine as (Article 13(1) of Injection for defined in Directive No cattle, sheep and relevant national 2001/82/EC) pigs legislation

Bimprocil 300 Bimeda Animal VPA22033/076/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin Generic - Intramuscular mg/ml Health Limited 001 milligram(s)/millil injection Prescription Only procaine application use suspension for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle, sheep and relevant national 2001/82/EC) pigs legislation

Bioamoxi 500 V.M.D. n.v/s.a. VPA10817/001/ 500 Powder for oral - QJ01CA04 POM: - Amoxicillin Well-established - Oral use mg/g powder for 001 milligram(s)/gra solution Prescription Only use application oral solution for m Medicine as (Article 13a of chicken defined in Directive No relevant national 2001/82/EC) legislation

Biocillin 1000 Bela-Pharm VPA10445/002/ 1000 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - Oral use mg/g Powder for GmbH & Co. KG 001 milligram(s)/gra in drinking water Prescription Only trihydrate application use in drinking m Medicine as (Article 13(1) of water for defined in Directive No chickens, ducks relevant national 2001/82/EC) and turkeys legislation

Bioestrovet Vetoquinol VPA10983/043/ 0.250 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular 0.250 mg/ml Ireland Limited 001 milligram(s)/millil injection Prescription Only sodium application use solution for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 21 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration BIOSUIS Bioveta, a.s. VPA22028/003/ . Suspension for - QI09AL01 POM: - Porcine Full application - Intramuscular ParvoEry 001 injection Prescription Only parvovirus (Article 12(3) of use suspension for Medicine as inactivated Directive No injection for pigs defined in - erysipelothrix 2001/82/EC) relevant national rhusiopathiae, legislation inactivated

BIOSUIS Salm Bioveta, a.s. VPA22028/001/ . Emulsion for - QI09AB14 POM: - Salmonella Full application - Intramuscular emulsion for 001 injection Prescription Only enterica subsp. (Article 12(3) of use injection for pigs Medicine as enterica sv. Directive No defined in Typhimurium 2001/82/EC) relevant national (wild type, legislation fagotype: DT104) - Salmonella enterica subsp. enterica sv. Derby (wild type, PFGE type: De1) - Salmonella enterica subsp. enterica sv. Infantis (wild type)

Bisolvon 10mg/g Boehringer VPA10454/002/ 10 Oral powder - QR05CB02 POM: - Bromhexine - Oral use Oral Powder Ingelheim 001 milligram(s)/gra Prescription Only hydrochloride Vetmedica m Medicine as GmbH defined in relevant national legislation

Blackleg Vaccin Zoetis Belgium VPA10387/002/ . Suspension for - QI02AB01 LM: Licensed - Clostridium Full application - Subcutaneous S.A. 001 injection - QI04AB01 Merchant as chauvoei whole (Article 12(3) of use defined in culture, Directive No relevant national inactivated 2001/82/EC) legislation

BLACKLEG Intervet Ireland VPA10996/142/ . Suspension for - QI02AB01 LM: Licensed - Clostridium Full application - Subcutaneous VACCINE Limited 001 injection - QI04AB01 Merchant as chauvoei cells (Article 12(3) of use defined in and equivalent Directive No relevant national toxoid of strain 2001/82/EC) legislation 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 Blast LHV Bonapp HOVR10466/00 . Oral solution LM: Licensed - Calcarea Simplified - Oral use 3/001 Merchant as carbonica Registration of a defined in - Silica Veterinary relevant national - Carbo Homeopathic legislation vegetabilis Medicinal - Phytolacca Product (Article decandra 16, Directive - Solidago 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 22 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration BLOCKADE 0.25 DeLaval NV VPA10827/002/ 0.25 percent Teat dip solution - QG52A LM: Licensed - Available iodine Full application - Topical use % w/w iodine 001 weight/weight Merchant as (Article 12(3) of teat dip solution defined in Directive No relevant national 2001/82/EC) legislation

Bob Martin Clear The Bob Martin VPA10881/008/ 1.9/4.9 Shampoo - QP53AC CAM: - Piperonyl ZZZ Complete - Topical use Flea Shampoo Company 001 milligram(s)/gra Companion butoxide application for Dogs & m Animal Medicine - Pyrethrum pale (stand-alone) - Puppies 1.9 as defined in extract 25% Council Directive mg/g / 4.9 mg/g relevant national 81/851/EEC legislation

Bob Martin Clear The Bob Martin VPA10881/001/ 100 mg/tablet Coated tablet - QP52AX01 CAM: - Nitroscanate - Oral use Wormer 100 mg Company 001 Companion Film Coated Animal Medicine Tablets for Small as defined in Dogs and relevant national Puppies legislation

Bob Martin Clear The Bob Martin VPA10881/002/ 500 mg/tablet Coated tablet - QP52AX01 CAM: - Nitroscanate - Oral use Wormer 500 mg Company 001 Companion Film Coated Animal Medicine Tablets for Dogs as defined in relevant national legislation

Bob Martin Easy The Bob Martin VPA10881/006/ 222.2 Granules - QP52AC13 CAM: - Fenbendazole Informed - Oral use to Use Wormer Company 001 milligram(s)/gra Companion consent Granules for m Animal Medicine application Cats as defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Bob Martin Easy Chanelle VPA10987/116/ 222.2 Granules - QP52AC13 CAM: - Fenbendazole - Oral use to Use Wormer Pharmaceuticals 002 milligram(s)/gra Companion Granules for Manufacturing m Animal Medicine Large Dogs Limited as defined in relevant national legislation

Bob Martin Easy Chanelle VPA10987/116/ 222.2 Granules - QP52AC13 CAM: - Fenbendazole - Oral use to Use Wormer Pharmaceuticals 001 milligram(s)/gra Companion Granules for Manufacturing m Animal Medicine Small Dogs Limited as defined in relevant national legislation

Bob Martin Flea The Bob Martin VPA10881/010/ 1.28,1.57 Cutaneous - QP53AC51 CAM: - Pyrethrum pale - Topical use Spray cutaneous Company 001 percent spray, solution Companion extract 25% spray solution weight/volume Animal Medicine - Piperonyl as defined in butoxide relevant national legislation

Boflox flavour 20 LIVISTO Int'l, VPA10425/004/ 20 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use mg tablets for S.L. 001 Prescription Only application dogs and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Boflox flavour 80 LIVISTO Int'l, VPA10425/004/ 80 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use mg tablets for S.L. 002 Prescription Only application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 23 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Boflox, 100 Industrial VPA10509/003/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular mg/ml solution Veterinaria, S.A. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

BONHAREN IVN Contipro a.s. VPA22837/001/ 10 Solution for - QM09AX01 VPO: Veterinary - Sodium Generic - Intravenous 10 mg/ml 001 milligram(s)/millil injection Practitioner Only hyaluronate application use solution for itre as defined in (Article 13(1) of injection for relevant national Directive No horses and dogs legislation 2001/82/EC)

Borgal 24% Virbac S.A. VPA10988/082/ 200, 40 Solution for - QJ01EW13 POM: - Sulfadoxine Full application - Intramuscular Solution for 001 milligram(s)/millil injection Prescription Only - Trimethoprim (Article 12(3) of use Injection itre Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national - Subcutaneous legislation use

Bovaclox DC Norbrook VPA22664/005/ 500, 250 Intramammary - QJ51RC POM: - Cloxacillin Full application - Intramammary Intramammary Laboratories 001 mg/syringe suspension Prescription Only benzathine (Article 12(3) of use Suspension (Ireland) Limited Medicine as - Ampicillin Directive No defined in trihydrate 2001/82/EC) relevant national legislation

Bovaclox DC Norbrook VPA22664/038/ 600, 300 Intramammary - QJ51CR50 POM: - Cloxacillin Full application - Intramammary Xtra Laboratories 001 mg/syringe suspension Prescription Only benzathine (Article 12(3) of use (Ireland) Limited Medicine as - Ampicillin Directive No defined in trihydrate 2001/82/EC) relevant national legislation

BOVALTO Boehringer VPA10454/028/ . Suspension for - QI02AB04 POM (E): - Mannheimia Full application - Intramuscular PASTOBOV Ingelheim 001 injection Prescription Only haemolytica type (Article 12(3) of use Vetmedica Exempt as 1a antigen Directive No - Subcutaneous GmbH defined in leucotoxin 2001/82/EC) use relevant national legislation

BOVALTO Respi Boehringer VPA10454/029/ . Suspension for - QI02AL POM (E): - Inactivated Full application - Subcutaneous 3 suspension for Ingelheim 001 injection Prescription Only bovine (Article 12(3) of use injection Vetmedica Exempt as respiratory Directive No GmbH defined in syncytial virus, 2001/82/EC) relevant national strain bio-24 legislation - Inactivated bovine parainfluenza 3 virus, strain bio- 23 - Inactivated mannheimia (pasteurella) haemolyica, a1 strain dsm 5283 BOVALTO Respi Boehringer VPA10454/029/ . Suspension for - QI02AL POM (E): - Inactivated Full application - Subcutaneous 4 suspension for Ingelheim 002 injection Prescription Only bovine (Article 12(3) of use injection Vetmedica Exempt as respiratory Directive No GmbH defined in syncytial virus, 2001/82/EC) relevant national strain bio-24 legislation - Inactivated bovine parainfluenza 3 virus, strain bio- 23 - Inactivated mannheimia haemolytica serotype a1 strain dsm 5283 - Inactivated bovine viral diarrhoea virus, strain bio-25

Veterinary Medicines Authorised/Transfer Pending Products Page 24 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration BOVALTO Boehringer VPA10454/029/ . Nasal spray, - QI02AD07 POM (E): - Bovine Full application - Nasal use RESPI Ingelheim 003 lyophilisate and Prescription Only respiratory (Article 12(3) of INTRANASAL, Vetmedica solvent for Exempt as syncytial virus, Directive No nasal spray, GmbH suspension defined in live 2001/82/EC) lyophilisate and relevant national - Bovine solvent for legislation parainfluenza suspension virus 3 attenuated Bovex 2.265% Chanelle VPA10987/039/ 2.265 percent Oral suspension - QP52AC02 POM: - Oxfendazole - Oral use Pharmaceuticals 001 weight/volume Prescription Only Manufacturing Medicine as Limited defined in relevant national legislation

Bovi.BLI.Compl Galway HOVR10537/00 . Oral solution LM: Licensed Simplified - Oral use ex Homoeopathics 5/001 Merchant as Registration of a (Manufacturing) defined in Veterinary Limited relevant national Homeopathic legislation Medicinal Product (Article 16, Directive 2001/82/EC) Bovi.BLS.Compl Galway HOVR10537/00 . Oral solution LM: Licensed Simplified - Oral use ex Homoeopathics 4/001 Merchant as Registration of a (Manufacturing) defined in Veterinary Limited relevant national Homeopathic legislation Medicinal Product (Article 16, Directive 2001/82/EC) BOVICEF DC Zoetis Belgium VPA10387/003/ 250 mg/syringe Intramammary - QJ51DB90 POM: - Cefalonium Hybrid - Intramammary 250 mg S.A. 001 suspension Prescription Only dihydrate application use Intramammary Medicine as (Article 13(3) of Suspension for defined in Directive No Cattle relevant national 2001/82/EC) legislation

Bovicox 50 J. & M. VPA10954/011/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml oral Veterinary 001 milligram(s)/millil Prescription Only application suspension for Services Ltd itre Medicine as (Article 13(1) of cattle and sheep defined in Directive No relevant national 2001/82/EC) legislation

BOVIDEC Benchmark VPA22980/001/ . Suspension for - QI02AA01 POM (E): - Bovine viral - Subcutaneous Animal Health 001 injection Prescription Only diarrhoea (bvd) use Norway AS Exempt as virus strain (trading as defined in ky1203nc Benchmark relevant national (inactivated): Animal Health) legislation

Bovidip 2 %w/v DeLaval NV VPA10827/003/ 2 percent Teat dip/spray - QG52A LM: Licensed - Available iodine Well-established - Topical use Concentrate for 001 weight/volume solution Merchant as use application Teat Dip or defined in (Article 13a of Spray Solution relevant national Directive No for bovine legislation 2001/82/EC)

BOVIGEN FORTE VPA10806/004/ . Emulsion for - QI02AL01 POM: - Bovine Full application - Intramuscular SCOUR Healthcare Ltd 001 injection Prescription Only coronavirus (Article 12(3) of use Emulsion for Medicine as strain c-197 Directive No injection for defined in (inactivated) 2001/82/EC) cattle relevant national - Bovine legislation rotavirus strain TM-91, serotype G6P1 (inactivated). - Escherichia coli strain EC/17, (inactivated) expressing F5(K99) adhesin

Veterinary Medicines Authorised/Transfer Pending Products Page 25 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Bovilis Bovipast Intervet Ireland VPA10996/152/ . Suspension for - QI02AL04 POM (E): - Inactivated Full application - Subcutaneous RSP suspension Limited 001 injection Prescription Only bovine (Article 12(3) of use for injection for Exempt as respiratory Directive No cattle defined in syncytial virus 2001/82/EC) relevant national strain ev908 legislation - Inactivated Parainfluenza-3- virus, strain SF-4 Reisinger - Inactivated mannheimia (pasteurella) haemolyticaA1, strain M4/1 Bovilis Bovivac Intervet Ireland VPA10996/165/ . Suspension for - QI02AB POM (E): - Salmonella Full application - Subcutaneous Limited 001 injection Prescription Only dublin strain (Article 12(3) of use Exempt as s342/70 formalin Directive No defined in inactivated 2001/82/EC) relevant national - Salmonella legislation typhimurium strain s341/70 formalin inactivated

Bovilis BVD Intervet Ireland VPA10996/271/ . Suspension for - QI02AA01 POM (E): - Inactivated Full application - Intramuscular Suspension for Limited 001 injection Prescription Only antigen of (Article 12(3) of use injection for Exempt as cytopathogenic Directive No cattle defined in BVDV strain C- 2001/82/EC) relevant national 86 legislation

Bovilis Huskvac Intervet Ireland VPA10996/081/ . Oral suspension - QI02AN01 POM (E): - Inactivated Full application - Oral use Limited 001 Prescription Only cells and (Article 12(3) of Exempt as equivalent toxoid Directive No defined in of irradiated 3rd 2001/82/EC) relevant national stage of legislation dictyocaulus vivipatrous

Bovilis IBR Intervet Ireland VPA10996/200/ 60 enzyme- Suspension for - QI02AA03 POM (E): - Inactivated Immunological - Intramuscular marker inac Limited 001 linked injection Prescription Only antigen of BHV-1 veterinary use Suspension for immunosorbent Exempt as (gE) strain GK/D medicinal injection for assay unit defined in product cattle relevant national application legislation (Article 13d of Directive No 2001/82/EC) Bovilis IBR Intervet Ireland VPA10996/172/ . Lyophilisate and - QI02AD01 POM (E): - Glycoprotein E Full application - Intramuscular marker live, Limited 001 solvent for Prescription Only deficient (gE-) (Article 12(3) of use lyophilisate and suspension for Exempt as Bovine Herpes Directive No - ZZZ Intranasal solvent for injection defined in Virus Type 1 2001/82/EC) use suspension for relevant national (BHV-1), strain cattle legislation GK/D (gE-)1

Bovilis Intervet Ireland VPA10996/276/ . Lyophilisate and - QI02AD07 POM (E): - Bovine Full application - Nasal use INtranasal RSP Limited 001 solvent for Prescription Only parainfluenza (Article 12(3) of Live, nasal suspension for Exempt as virus type 3 (live) Directive No spray, nasal defined in strain INT2-2013 2001/82/EC) lyophilisate and administration relevant national - Bovine solvent for legislation respiratory suspension for syncytial virus cattle (live) strain Jencine-2013

Veterinary Medicines Authorised/Transfer Pending Products Page 26 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Bovilis Ringvac Intervet Ireland VPA10996/284/ . Lyophilisate and - QI02AP01 POM: - Attenuated Full application - Intramuscular lyophilisate and Limited 001 solvent for Prescription Only micronidia of (Article 12(3) of use solvent for suspension for Medicine as trichophyton Directive No suspension for injection defined in verrucosum 2001/82/EC) injection for relevant national strain ltf-130 cattle legislation - Attenuated micronidia of trichophyton verrucosum strain ltf-130 - Attenuated micronidia of trichophyton verrucosum strain ltf-130 Bovilis Rotavec Intervet Ireland VPA10996/216/ . Emulsion for - QI02AL01 POM: - Bovine Full application - Intramuscular Corona emulsion Limited 001 injection Prescription Only rotavirus, strain (Article 12(3) of use for injection for Medicine as UK-Compton, Directive No cattle defined in serotype G6 P5 2001/82/EC) relevant national (inactivated) legislation - Bovine coronavirus - E.coli, f5 adhesin (k99) Bovimast DC, Bimeda Animal VPA22033/003/ 500 mg/syringe Intramammary - QJ51CF POM: - Cloxacillin Informed - Intramammary 500 mg Health Limited 001 suspension Prescription Only benzathine consent use cloxacillin/syring Medicine as application e, Intramammary defined in (Article 13c of suspension relevant national Directive No legislation 2001/82/EC)

Bovimec 10 Bimeda Animal VPA22033/050/ 10 Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous mg/ml solution Health Limited 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of cattle defined in Directive No relevant national 2001/82/EC) legislation

Bovimectin 1 % Bimeda Animal VPA22033/051/ 1.0 percent Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous solution for Health Limited 001 weight/volume injection Prescription Only application use injection for Medicine as (Article 13(1) of cattle defined in Directive No relevant national 2001/82/EC) legislation

Bovipour 5 Chanelle VPA10987/162/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin Generic - Topical use mg/ml Pour-on Pharmaceuticals 001 milligram(s)/millil Prescription Only application Solution for Manufacturing itre Medicine as (Article 13(1) of Cattle Limited defined in Directive No relevant national 2001/82/EC) legislation

Bovis LHV Bonapp HOVR10466/00 . Oral solution LM: Licensed - Calcarea Simplified - Oral use 2/001 Merchant as carbonica Registration of a defined in - Atropa Veterinary relevant national belladonna Homeopathic legislation - Allium cepa oil Medicinal - Euphrasia Product (Article officinalis 16, Directive - Carbo 2001/82/EC) vegetabilis - Solidago virgaurea Boviseal Dry cow Zoetis Belgium VPA10387/101/ 2.6 gram(s) Intramammary - QG52X LM: Licensed - Bismuth Full application - Intramammary intramammary S.A. 001 suspension Merchant as subnitrate, heavy (Article 12(3) of use suspension defined in Directive No relevant national 2001/82/EC) legislation

Bovitec Plus Oral J. & M. VPA10954/009/ 150 Oral suspension - QP52AC11 POM: - Albendazole Informed - Oral use Suspension Veterinary 001 milligram(s)/millil Prescription Only consent Services Ltd itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 27 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Britt LHV Bonapp HOVR10466/00 Oral solution LM: Licensed - Bellis perennis - Oral use 8/001 Merchant as - Calcarea defined in carbonica relevant national - Calendula legislation officinalis - Solidago - Atropa belladonna - Carbo vegetabilis Bromhex-Air Pharmanovo VPA10420/002/ 25 Oral powder - QR05CB02 POM: - Bromhexine Hybrid - In drinking forte 25 mg/g Veterinärarznei 001 milligram(s)/gra Prescription Only hydrochloride application water use oral powder for mittel GmbH m Medicine as (Article 13(3) of - In-feed use cattle, pigs, defined in Directive No chickens, turkeys relevant national 2001/82/EC) and ducks legislation

BRONCHI- Zoetis Belgium VPA10387/004/ 2.1x 10^6 - 5.5 x Lyophilisate and - QI07AE01 POM: - Bordetella Full application - ZZZ Intranasal SHIELD, S.A. 001 10^ 8 colony solvent for nasal Prescription Only bronchiseptica, (Article 12(3) of use lyophilisate and forming drops, Medicine as live, attenuated Directive No solvent for unit(s)/millilitre suspension defined in strain 92b 2001/82/EC) suspension for relevant national nasal drops for legislation dogs Bupaq Multidose Richter Pharma VPA10801/005/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Generic - Intramuscular 0.3 mg/ml AG 001 milligram(s)/millil injection Practitioner Only application use Solution for itre as defined in (Article 13(1) of - Intravenous Injection for relevant national Directive No use Dogs and Cats legislation 2001/82/EC)

Buprecare 0.3 Ecuphar NV VPA10491/004/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Generic - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for Injection for itre as defined in (Article 13(1) of Dogs and Cats relevant national Directive No legislation 2001/82/EC)

Buprecare Ecuphar NV VPA10491/004/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Generic - Intramuscular Multidose 0.3 002 milligram(s)/millil injection Practitioner Only hydrochloride application use mg/ml Solution itre as defined in (Article 13(1) of - Intravenous for Injection for relevant national Directive No use Dogs and Cats legislation 2001/82/EC)

Buprefelican Le Vet Beheer VPA10475/021/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Generic - Intramuscular Multidose 0.3 B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use mg/ml solution itre as defined in (Article 13(1) of - Intravenous for injection for relevant national Directive No use dogs and cats legislation 2001/82/EC)

Buscopan Boehringer VPA10454/004/ 4/500 Solution for - QA03DB04 POM: - - Intramuscular Compositum Ingelheim 001 milligram(s)/millil injection Prescription Only Butylscopolamin use Solution for Vetmedica itre Medicine as e bromide - Intravenous Injection GmbH defined in - Metamizole use relevant national legislation

Busol 0.004 T.P. Whelehan VPA10953/003/ 0.004 Solution for - QH01CA90 POM: - Buserelin Well-established - Intramuscular mg/ml solution Son & Co. Ltd., 001 milligram(s)/millil injection Prescription Only acetate use application use for injection for itre Medicine as (Article 13a of - Intravenous cattle, horses, defined in Directive No use rabbits relevant national 2001/82/EC) - Subcutaneous legislation use

Butador 10 Richter Pharma VPA10801/004/ 10 Solution for - QN02AF01 POM: - Butorphanol Generic - Intramuscular mg/ml solution AG 001 milligram(s)/millil injection Prescription Only (equivalent to application use for injection for itre Medicine as butorphanol (Article 13(1) of - Intravenous horses, dogs and defined in tartrate usp 14.6 Directive No use cats relevant national mg) 2001/82/EC) - Subcutaneous legislation - Butorphanol use (equivalent to 14.58 mg Butorphanol tartrate)

Veterinary Medicines Authorised/Transfer Pending Products Page 28 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Butasal 100 Interchemie VPA22812/003/ 100.0 + 0.05 Solution for - QA12CX99 POM: - Hybrid - Intramuscular mg/ml + 0.05 Werken De 001 milligram(s)/millil injection Prescription Only Cyanocobalamin application use mg/ml solution Adelaar Eesti AS itre Medicine as - Butafosfan (Article 13(3) of - Intravenous for injection for defined in Directive No use horses, cattle, relevant national 2001/82/EC) - Subcutaneous dogs and cats legislation use

Butox 7.5 mg/ml Intervet Ireland VPA10996/103/ 7.5 Pour-on - QP53AC11 POM: - Deltamethrin - Topical use Pour On Limited 001 milligram(s)/millil suspension Prescription Only Suspension itre Medicine as defined in relevant national legislation

ByeMite 500 Elanco GmbH VPA22020/049/ 500 Concentrate for - QP53AF01 POM: - Phoxim Generic - ZZZ Spray mg/ml 001 milligram(s)/millil cutaneous spray, Prescription Only application concentrate for itre emulsion Medicine as (Article 13(1) of spraying defined in Directive No emulsion for relevant national 2001/82/EC) laying hens legislation

Cadorex 300 LIVISTO Int'l, VPA10425/002/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular mg/ml solution S.L. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle, sheep and defined in Directive No use pigs relevant national 2001/82/EC) legislation

Calcibel Bela-Pharm VPA10445/003/ 240/60/60 Solution for - QA12AX POM: - Calcium Hybrid - Intravenous 240/60/60 mg/ml GmbH & Co. KG 001 milligram(s)/millil infusion Prescription Only gluconate for application use solution for itre Medicine as injection (Article 13(3) of infusion for defined in - Magnesium Directive No horses, cattle, relevant national chloride 2001/82/EC) sheep, goats and legislation hexahydrate pigs - Boric acid Calciject 40 + 3 Norbrook VPA22664/032/ 332, 30, 68 Solution for - QA12 LM: Licensed - Calcium - Intravenous Solution for Laboratories 001 milligram(s)/millil injection Merchant as gluconate use Injection (Ireland) Limited itre defined in - Magnesium - Subcutaneous relevant national hypophosphite use legislation hexahydrate - Boric acid Calciject 40 Norbrook VPA22664/031/ 400,68 Solution for - QA12A LM: Licensed - Calcium ZZZ Complete - Intravenous Solution for Laboratories 001 milligram(s)/millil injection Merchant as borogluconate application use Injection (Ireland) Limited itre defined in - Boric acid (stand-alone) - - Subcutaneous relevant national Council Directive use legislation 81/851/EEC

Calciject LV Norbrook VPA22664/044/ 388.5, 73.4, Solution for - QA12 LM: Licensed - Boric acid - Intravenous Solution for Laboratories 001 65.0, 13.2 injection Merchant as - Calcium use Injection (Ireland) Limited milligram(s)/millil defined in gluconate - Subcutaneous itre relevant national - Magnesium use legislation chloride hexahydrate - Calcium hydroxide Calciject PMD Norbrook VPA22664/029/ 166, 34, 200, 50 Solution for - QA12AA20 LM: Licensed - Boric acid - Intravenous Solution for Laboratories 001 milligram(s)/millil injection Merchant as - Calcium use Injection (Ireland) Limited itre defined in gluconate - Subcutaneous relevant national - Dextrose use legislation Monohydrate - Magnesium hypophosphite hexahydrate Calcipharm 40 Chem-Pharm VPA10823/015/ 332, 68
Solution for - QA12AA LM: Licensed - Calcium Informed - Intravenous Solution for 001 milligram(s)/millil injection Merchant as gluconate consent use Injection itre defined in - Boric acid application - Subcutaneous relevant national (Article 13c of use legislation Directive No 2001/82/EC) Calcipharm PMD Chem-Pharm VPA10823/014/ 166, 50, 200, Solution for - QA12 LM: Licensed - Calcium Informed - Intravenous Solution for 001 34
injection Merchant as gluconate consent use Injection milligram(s)/millil defined in - Magnesium application - Subcutaneous itre relevant national hypophosphite (Article 13c of use legislation - Dextrose Directive No monohydrate 2001/82/EC) - Boric acid

Veterinary Medicines Authorised/Transfer Pending Products Page 29 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Calcitat 25, aniMedica VPA10826/001/ 1.55, 21.45, Solution for - QA12AA LM: Licensed - Calcium Well-established - Intravenous solution for GmbH 001 0.66, 3.25 injection/infusion Merchant as gluconate use application use infusion and grams/100 defined in monohydrate (Article 13a of - Subcutaneous injection in cattle millilitres relevant national - Calcium Directive No use legislation borogluconate 2001/82/EC) - Calcium hydroxide - Magnesium chloride hexahydrate Calcitat 50, aniMedica VPA10826/001/ 3.10, 42.960, Solution for - QA12AA LM: Licensed - Calcium - Intravenous solution for GmbH 002 1.32, 6.50 injection/infusion Merchant as gluconate use infusion and grams/100 defined in monohydrate - Subcutaneous injection in cattle millilitres relevant national - Calcium use legislation borogluconate - Calcium hydroxide - Magnesium chloride hexahydrate Calcivet Solution Norbrook VPA22664/054/ 332, 68, 30 Solution for - QA12A LM: Licensed - Calcium Informed - Intravenous for Injection for Laboratories 001 milligram(s)/millil injection Merchant as gluconate consent use Cattle (Ireland) Limited itre defined in - Boric acid application - Subcutaneous relevant national - Magnesium (Article 13c of use legislation hypophosphite Directive No hexahydrate 2001/82/EC) Calicide, Trouw VPA10862/001/ 1000 Premix for - QP53BC03 POM: - Technical Full application - Oral use Teflubenzuron Aquaculture Ltd 001 gram(s)/kilogra medicated Prescription Only teflubenzuron (Article 12(3) of 1000 g/kg (T/A Skretting) m(s) feeding stuff Medicine as Directive No Premix for defined in 2001/82/EC) medicated relevant national feeding stuff legislation

Calmafusion, Interchemie VPA22812/001/ 380.0, 60.0, 50.0 Solution for - QA12AX POM: - Calcium Generic - Intravenous 380mg/60mg/50 Werken De 001 milligram(s)/millil infusion Prescription Only gluconate for application use mg, solution for Adelaar Eesti AS itre Medicine as injection (Article 13(1) of infusion for defined in - Magnesium Directive No cattle, sheep and relevant national chloride 2001/82/EC) pigs legislation hexahydrate - Boric acid Canaural ear Dechra VPA10803/003/ . Ear drops, - QS02CA01 POM: - Diethanolamine ZZZ --Unknown- - Auricular use drops, Veterinary 001 suspension Prescription Only Fusidate suspension for Products A/S Medicine as - Framycetin dogs and cats defined in sulphate relevant national - Nystatin legislation - Prednisolone

Canergy 100 mg Le Vet Beheer VPA10475/016/ 100 mg/tablet Tablet - QC04AD90 POM: - Propentofylline Generic - Oral use tablets for dogs B.V. 001 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Canidryl 100 mg Chanelle VPA10987/064/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for dogs Pharmaceuticals 003 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Canidryl 20 mg Chanelle VPA10987/064/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for dogs Pharmaceuticals 001 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Canidryl 50 mg Chanelle VPA10987/064/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for dogs Pharmaceuticals 002 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 30 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Caninsulin 40 Intervet Ireland VPA10996/048/ 40 international Suspension for - QA10AC03 POM: - Insulin - Subcutaneous IU/ml Limited 001 unit(s)/millilitre injection Prescription Only use Suspension for Medicine as Injection defined in relevant national legislation

Canishield 0.77 Beaphar B.V. VPA10455/003/ 0.77 Medicated collar - QP53AC11 POM: - Deltamethrin Hybrid - Cutaneous use g medicated 002 gram(s)/collar Prescription Only application collar for small Medicine as (Article 13(3) of and medium defined in Directive No sized dogs relevant national 2001/82/EC) legislation

Canishield 1.04 Beaphar B.V. VPA10455/003/ 1.04 gram(s) Collar - QP53AC11 POM: - Deltamethrin Hybrid - Cutaneous use g medicated 001 Prescription Only application collar for large Medicine as (Article 13(3) of sized dogs defined in Directive No relevant national 2001/82/EC) legislation

CANIXIN DHPPi Virbac S.A. VPA10988/101/ . cell culture Lyophilisate and - QI07AD04 POM: - Canine Full application - Subcutaneous lyophilisate and 001 infective dose 50 solvent for Prescription Only distemper virus (Article 12(3) of use solvent for suspension for Medicine as (lederle strain) Directive No suspension for injection defined in - Canine 2001/82/EC) injection for dogs relevant national parvovirus (cpv legislation 780916 strain) - Canine adenovirus type 2 (manhattan strain) - Canine parainfluenza (manhattan strain) CANIXIN Virbac S.A. VPA10988/101/ . Lyophilisate and - QI07AI02 POM: - Canine Full application - Subcutaneous DHPPi/L 002 suspension for Prescription Only distemper virus (Article 12(3) of use lyophilisate suspension for Medicine as - Canine Directive No suspension for injection defined in adenovirus type 2001/82/EC) injection for dogs relevant national 2 legislation - Canine parvovirus - Canine parainfluenza - L.canicola - L. icterohaemorrha giae Canixin L Virbac S.A. VPA10988/102/ . Suspension for - QI07AB01 POM: - Leptospira Full application - Subcutaneous suspension for 001 injection Prescription Only interrogans (Article 12(3) of use injection for dogs Medicine as serogroup Directive No defined in icterohaemorrag 2001/82/EC) relevant national iae, inactivated legislation - Leptospira interrogans serogroup canicola, inactivated

CANIXIN Pi/L Virbac S.A. VPA10988/103/ . Lyophilisate and - QI07AI08 POM: - Canine Full application - Subcutaneous lyophilisate and 001 suspension for Prescription Only Parainfluenza, (Article 12(3) of use suspension for suspension for Medicine as live Directive No suspension for injection defined in - Leptospira 2001/82/EC) injection for dogs relevant national interrogans legislation serogroup canicola, inactivated - Leptospira interrogans serogroup icterohaemorrag iae, inactivated

Veterinary Medicines Authorised/Transfer Pending Products Page 31 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Cardisure Eurovet Animal VPA10989/059/ 5 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use flavoured 5 mg Health B.V. 003 Prescription Only application Tablets For dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Cardisure 3.5 Dechra VPA22622/026/ 3.5 Oral solution - QC01CE90 POM: - Pimobendan Hybrid - Oral use mg/ml Oral Regulatory B.V. 001 milligram(s)/millil Prescription Only application Solution for Dog itre Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Cardisure Eurovet Animal VPA10989/059/ 1.25 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use flavoured 1.25 Health B.V. 001 Prescription Only application mg Tablets For Medicine as (Article 13(1) of dogs defined in Directive No relevant national 2001/82/EC) legislation

Cardisure Eurovet Animal VPA10989/059/ 10 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use flavoured 10 mg Health B.V. 004 Prescription Only application Tablets For dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Cardisure Eurovet Animal VPA10989/059/ 2.5 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use flavoured 2.5 mg Health B.V. 002 Prescription Only application Tablets For dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carofertin 10 V.M.D. n.v. VPA16142/004/ 10 Emulsion for - QA11CA02 POM: - Betacarotene Generic - Intramuscular mg/ml Emulsion 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of cattle and pigs defined in Directive No relevant national 2001/82/EC) legislation

Carporal 160 mg Le Vet Beheer VPA10475/019/ 160 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use tablets for dogs B.V. 002 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carporal 40 mg Le Vet Beheer VPA10475/019/ 40 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use tablets for dogs B.V. 001 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carprieve 100 Norbrook VPA22664/091/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use mg Flavoured Laboratories 003 Prescription Only application Tablets for Dogs (Ireland) Limited Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carprieve 100 Norbrook VPA22664/071/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use mg Tablets for Laboratories 003 Prescription Only application Dogs (Ireland) Limited Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 32 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Carprieve 20 mg Norbrook VPA22664/091/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Flavoured Laboratories 001 Prescription Only application Tablets for Dogs (Ireland) Limited Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carprieve 20 mg Norbrook VPA22664/071/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for Dogs Laboratories 001 Prescription Only application (Ireland) Limited Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carprieve 5 Norbrook VPA22664/069/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous %w/v Small Laboratories 001 milligram(s)/millil injection Prescription Only application use Animal Solution (Ireland) Limited itre Medicine as (Article 13(1) of - Subcutaneous for Injection defined in Directive No use relevant national 2001/82/EC) legislation

Carprieve 50 mg Norbrook VPA22664/091/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Flavoured Laboratories 002 Prescription Only application Tablets for Dogs (Ireland) Limited Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carprieve 50 mg Norbrook VPA22664/071/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for Dogs Laboratories 002 Prescription Only application (Ireland) Limited Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carprieve 50 Norbrook VPA22664/080/ 50 Solution for - QM01AE91 POM: - Carprofen Well-established - Intravenous mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only use application use for Injection for (Ireland) Limited itre Medicine as (Article 13a of - Subcutaneous Cattle defined in Directive No use relevant national 2001/82/EC) legislation

Carprodolor 50 Le Vet Beheer VPA10475/003/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle defined in Directive No use relevant national 2001/82/EC) legislation

Carprodyl F 100 Ceva Santé VPA10815/003/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use mg, tablets for Animale 003 Prescription Only application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carprodyl F 20 Ceva Santé VPA10815/003/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use mg, tablets for Animale 001 Prescription Only application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carprodyl F 50 Ceva Santé VPA10815/003/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use mg, tablets for Animale 002 Prescription Only application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 33 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Carprodyl Quadri Ceva Santé VPA10815/045/ 120 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use 120 mg Animale 002 Prescription Only application chewable tablets Medicine as (Article 13(1) of for dogs defined in Directive No relevant national 2001/82/EC) legislation

Carprodyl Quadri Ceva Santé VPA10815/045/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use 50 mg tablets for Animale 001 Prescription Only application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Carprofelican 50 Le Vet Beheer VPA10475/007/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous dogs and cats defined in Directive No use relevant national 2001/82/EC) legislation

Carprofen KRKA Krka, d.d., Novo VPA10774/019/ 50 Solution for - QM01AE91 POM: - Carprofen for Generic - Intravenous 50 mg/ml mesto 001 milligram(s)/millil injection Prescription Only veterinary use application use solution for itre Medicine as (Article 13(1) of - Subcutaneous injection for dogs defined in Directive No use and cats relevant national 2001/82/EC) legislation

Carprogesic 20 Norbrook VPA22664/079/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use mg Tablets for Laboratories 001 Prescription Only dogs (Ireland) Limited Medicine as defined in relevant national legislation

Carprogesic 50 Norbrook VPA22664/079/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use mg Tablets for Laboratories 002 Prescription Only dogs (Ireland) Limited Medicine as defined in relevant national legislation

Carprox vet 100 Krka, d.d., Novo VPA10774/006/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use mg tablets for mesto 003 Prescription Only dogs Medicine as defined in relevant national legislation

Carprox vet 20 Krka, d.d., Novo VPA10774/006/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use mg tablets for mesto 001 Prescription Only dogs Medicine as defined in relevant national legislation

Carprox vet 50 Krka, d.d., Novo VPA10774/006/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use mg tablets for mesto 002 Prescription Only dogs Medicine as defined in relevant national legislation

Carprox vet 50 Krka, d.d., Novo VPA10774/005/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous dogs and cats defined in Directive No use relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 34 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Cartrophen Vet Maperath Herbal VPA22748/001/ 100 Solution for - QM01AX90 VPO: Veterinary - Pentosan Full application - Subcutaneous 100 mg/ml Limited 001 milligram(s)/millil injection Practitioner Only polysulphate (Article 12(3) of use Solution for itre as defined in sodium Directive No Injection. relevant national 2001/82/EC) legislation

Catobevit 100 Krka, d.d., Novo VPA10774/052/ 100, 0.05 Solution for - QA12CX99 POM: - Butafosfan Generic, hybrid - Intramuscular mg/ml + 0.05 mesto 001 milligram(s)/millil injection Prescription Only - or similar use mg/ml solution itre Medicine as Cyanocobalamin biological - Intravenous for injection for defined in application use cattle, horses, relevant national (Article 13 of - Subcutaneous dogs and cats legislation Directive No use 2001/82/EC) Cazitel 230/20 Chanelle VPA10987/102/ 230, 20 Film-coated - QP52AA51 CAM: - Praziquantel Hybrid - Oral use mg Flavoured Pharmaceuticals 001 mg/tablet tablet Companion - Pyrantel application Film-Coated Manufacturing Animal Medicine embonate (Article 13(3) of Tablets for Cats Limited as defined in Directive No relevant national 2001/82/EC) legislation

Cazitel Plus Chanelle VPA10987/077/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use Tablets for Dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application Manufacturing Animal Medicine embonate (Article 10(3) of Limited as defined in - Febantel Directive No relevant national 2001/83/EC) legislation

Cazitel Plus XL Chanelle VPA10987/077/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Febantel application Manufacturing - QP52AF02 Animal Medicine - Pyrantel (Article 13(3) of Limited as defined in embonate Directive No relevant national 2001/82/EC) legislation

C-DIP Kilco VPA10948/002/ 0.5 percent Teat dip/spray - QD08AC02 LM: Licensed - Chlorhexidine - Topical use (International) 001 weight/volume solution Merchant as gluconate Ltd. defined in relevant national legislation

CEEMAST Dry Bimeda Animal VPA22033/004/ 500/500 Intramammary - QJ51RD01 POM: - Cefalexin Informed - Intramammary Cow Health Limited 001 mg/syringe suspension Prescription Only - consent use Intramammary Medicine as Dihydrostreptom application Suspension defined in ycin sulfate (Article 13c of relevant national Directive No legislation 2001/82/EC)

Cefabactin 1000 Le Vet Beheer VPA10475/024/ 1000 milligram(s Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use mg tablets for B.V. 004 Prescription Only monohydrate application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Cefabactin 250 Le Vet Beheer VPA10475/024/ 250 milligram(s) Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use mg tablets for B.V. 002 Prescription Only monohydrate application dogs and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Cefabactin 50 Le Vet Beheer VPA10475/024/ 50 milligram(s) Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use mg tablets for B.V. 001 Prescription Only monohydrate application dogs and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 35 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Cefabactin 500 Le Vet Beheer VPA10475/024/ 500 milligram(s) Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use mg tablets for B.V. 003 Prescription Only monohydrate application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Cefaseptin 300 Vetoquinol VPA10983/044/ 300 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Hybrid - Oral use mg tablets for Ireland Limited 002 Prescription Only application dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Cefaseptin 75 Vetoquinol VPA10983/044/ 75 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Hybrid - Oral use mg tablets for Ireland Limited 001 Prescription Only application dogs and cats Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Cefaseptin 750 Vetoquinol VPA10983/044/ 750 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Hybrid - Oral use mg tablets for Ireland Limited 003 Prescription Only application dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

CEFAVEX 50 SP Veterinaria, VPA10790/005/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular mg/ml, S.A. 001 milligram(s)/millil injection Prescription Only (hydrochloride) application use suspension for itre Medicine as (Article 13(1) of - Subcutaneous injection for pigs defined in Directive No use and cattle relevant national 2001/82/EC) legislation

Cefenil RTU, 50 Norbrook VPA22664/099/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular mg/ml, Laboratories 001 milligram(s)/millil injection Prescription Only Hydrochloride application use Suspension for (Ireland) Limited itre Medicine as (Article 13(1) of - Subcutaneous Injection for Pigs defined in Directive No use and Cattle relevant national 2001/82/EC) legislation

Ceffect 25 mg/ml Emdoka bvba VPA10534/003/ 25 Suspension for - QJ01DE90 POM: - Cefquinome Generic - Intramuscular suspension for 001 milligram(s)/millil injection Prescription Only sulphate application use injection for itre Medicine as (Article 13(1) of cattle and pigs defined in Directive No relevant national 2001/82/EC) legislation

Ceffect LC, 75 Emdoka bvba VPA10534/005/ 75 mg/syringe Intramammary - QJ01DE90 POM: - Cefquinome Generic - Intramammary mg, 001 ointment Prescription Only sulphate application use intramammary Medicine as (Article 13(1) of ointment for defined in Directive No lactating cows relevant national 2001/82/EC) legislation

Cefimam DC, Norbrook VPA22664/123/ 150 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Generic - Intramammary 150 mg Laboratories 001 ointment Prescription Only sulphate application use Intramammary (Ireland) Limited Medicine as (Article 13(1) of Ointment for Dry defined in Directive No Cows relevant national 2001/82/EC) legislation

Cefimam LC, 75 Norbrook VPA22664/120/ 75 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Generic - Intramammary mg Laboratories 001 ointment Prescription Only sulphate application use Intramammary (Ireland) Limited Medicine as (Article 13(1) of Ointment for defined in Directive No Lactating Cows relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 36 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration CEFOKEL 50 Kela n.v. VPA10981/015/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular mg/ml, 001 milligram(s)/millil injection Prescription Only Hydrochloride application use suspension for itre Medicine as (Article 13(1) of - Subcutaneous injection for pigs defined in Directive No use and cattle relevant national 2001/82/EC) legislation

Cefquinome Norbrook VPA22664/122/ 150 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Generic - Intramammary Norbrook DC, Laboratories 001 ointment Prescription Only sulphate application use 150 mg (Ireland) Limited Medicine as (Article 13(1) of Intramammary defined in Directive No Ointment for Dry relevant national 2001/82/EC) Cows legislation

Cefquinome Norbrook VPA22664/121/ 75 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Generic - Intramammary Norbrook LC, 75 Laboratories 001 ointment Prescription Only sulphate application use mg (Ireland) Limited Medicine as (Article 13(1) of Intramammary defined in Directive No Ointment for relevant national 2001/82/EC) Lactating Cows legislation

Ceftiocyl 50 Vetoquinol VPA10983/045/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular mg/ml, Ireland Limited 001 milligram(s)/millil injection Prescription Only application use suspension for itre Medicine as (Article 13(1) of - Subcutaneous injection for defined in Directive No use cattle and pigs relevant national 2001/82/EC) legislation

Ceftiocyl Fluid 50 Vetoquinol VPA10983/046/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular mg/ml, Ireland Limited 001 milligram(s)/millil injection Prescription Only application use suspension for itre Medicine as (Article 13(1) of injection for pigs defined in Directive No and cattle relevant national 2001/82/EC) legislation

Cemay 50 mg/ml Laboratorios VPA10436/001/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular suspension for Maymó, S.A. 001 milligram(s)/millil injection Prescription Only application use injection for pigs itre Medicine as (Article 13(1) of - Subcutaneous and cattle defined in Directive No use relevant national 2001/82/EC) legislation

Cephacare Ecuphar NV VPA10491/005/ 1000 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use Flavour 1000 mg 004 Prescription Only monohydrate application Tablets for Dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Cephacare Ecuphar NV VPA10491/005/ 250 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use flavour 250 mg 002 Prescription Only monohydrate application tablets for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Cephacare Ecuphar NV VPA10491/005/ 50 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use flavour 50 mg 001 Prescription Only monohydrate application tablets for cats Medicine as (Article 13(1) of and dogs defined in Directive No relevant national 2001/82/EC) legislation

Cephacare Ecuphar NV VPA10491/005/ 500 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use flavour 500 mg 003 Prescription Only monohydrate application tablets for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 37 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Cephaguard DC Virbac S.A. VPA10988/083/ 150 mg/syringe Intramammary - QJ51DA92 POM: - Cefquinome Full application - Intramammary 150 mg 001 ointment Prescription Only (Article 12(3) of use intramammary Medicine as Directive No ointment defined in 2001/82/EC) relevant national legislation

Ceporex 18 Intervet Ireland VPA10996/223/ 18 percent Suspension for - QJ01DB01 POM: - Cefalexin ZZZ Complete - Intramuscular %w/v Limited 001 weight/volume injection Prescription Only Sodium application use Suspension for Medicine as (stand-alone) - - Subcutaneous Injection defined in Council Directive use relevant national 81/851/EEC legislation

Cepralock 2.6 g Intervet Ireland VPA10996/287/ 2.6 gram(s) Intramammary - QG52X LM: Licensed - Bismuth Hybrid - Intramammary intramammary Limited 001 suspension Merchant as subnitrate, heavy application use suspension for defined in (Article 13(3) of Dry Cows relevant national Directive No legislation 2001/82/EC)

Cepravin Dry Intervet Ireland VPA10996/224/ 250 mg/syringe Intramammary - QJ51DA90 POM: - Cefalonium Full application - Intramammary Cow Limited 001 suspension Prescription Only dihydrate (Article 12(3) of use Intramammary Medicine as Directive No Suspension defined in 2001/82/EC) relevant national legislation

Cepritect 250 mg Norbrook VPA22664/142/ 250 mg/syringe Intramammary - QJ51DB90 POM: - Cefalonium Hybrid - Intramammary Intramammary Laboratories 001 suspension Prescription Only dihydrate application use Suspension for (Ireland) Limited Medicine as (Article 13(3) of Dry Cows defined in Directive No relevant national 2001/82/EC) legislation

Cevac IBD 2512 Ceva Santé VPA10815/020/ . Lyophilisate for - QI01AD09 POM: - Live infectious Similar biological - Oral use L lyophilisate for Animale 001 suspension Prescription Only bursal disease application oral suspension Medicine as (ibd) virus strain, (Article 13(4) of for chickens defined in winterfield 2512, Directive No relevant national g-61 2001/82/EC) legislation

CEVAC IBird Ceva Santé VPA10815/022/ . Lyophilisate for - QI01AD07 POM: - Live attenuated Full application - In drinking lyophilisate for Animale 001 suspension Prescription Only infectious (Article 12(3) of water use suspension for Medicine as bronchitis (ib) Directive No - ZZZ Spray chickens defined in virus, strain 1/96, 2001/82/EC) relevant national variant subtype legislation

CEVAC MASS L CEVA-Phylaxia VPA10463/004/ . Lyophilisate for - QI01AD07 POM: - Live attenuated Full application - Nebulisation lyophilisate for Veterinary 001 suspension Prescription Only infectious (Article 12(3) of use oculonasal Biologicals Co. Medicine as bronchitis Directive No suspension for Ltd defined in disease virus, 2001/82/EC) chickens relevant national Massachusetts legislation type, strain B48

Cevac MD HVT CEVA-Phylaxia VPA10463/005/ . Suspension and - QI01AD03 POM: - Turkey Full application - In ovo suspension and Veterinary 001 solvent for Prescription Only herpesirus, live (Article 12(3) of - Subcutaneous solvent for Biologicals Co. suspension for Medicine as Directive No use suspension for Ltd injection defined in 2001/82/EC) injection for relevant national chickens legislation

Cevac MD CEVA-Phylaxia VPA10463/007/ 800-5000 plaque Concentrate and - QI01AD03 POM: - Marek's Full application - Subcutaneous Rispens Veterinary 001 forming unit solvent for Prescription Only disease virus (Article 12(3) of use concentrate and Biologicals Co. suspension for Medicine as strain cvi 988 live Directive No solvent for Ltd injection defined in 2001/82/EC) suspension for relevant national injection for legislation chickens Cevac Meta L CEVA-Phylaxia VPA10463/003/ . Lyophilisate for - QI01AD01 POM: - Avian Full application - Nebulisation lyophilisate for Veterinary 001 suspension Prescription Only metapneumovir (Article 12(3) of use suspension for Biologicals Co. Medicine as us, subtype B, Directive No - Ocular use chickens Ltd defined in CRR126 strain 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 38 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration CEVAC Ceva Santé VPA10815/005/ . Lyophilisate and - QI01AD09 POM: - Live, Full application - In ovo TRANSMUNE Animale 001 solvent for Prescription Only attenuated (Article 12(3) of - Subcutaneous lyophilisate for suspension for Medicine as infectious bursal Directive No use suspension for injection defined in disease (IBD) 2001/82/EC) injection with relevant national virus, strain solvent for legislation winterfield 2512, chickens G-61

Cevaxel-RTU 50 Ceva Santé VPA10815/016/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular mg/ml, Animale 001 milligram(s)/millil injection Prescription Only application use suspension for itre Medicine as (Article 13(1) of - Subcutaneous injection for defined in Directive No use cattle and pigs relevant national 2001/82/EC) legislation

Cevazuril 50 Ceva Santé VPA10815/007/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml, oral Animale 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(1) of piglets and defined in Directive No calves relevant national 2001/82/EC) legislation

Chan Broad Chanelle VPA10987/010/ 22.5/15 Oral suspension - QP52AE01 POM: - Rafoxanide - Oral use Spec Oral Pharmaceuticals 001 milligram(s)/millil - QP52AG05 Prescription Only - Levamisole Suspension Manufacturing itre Medicine as hydrochloride Limited defined in relevant national legislation

Chan Pen Strep Chanelle VPA10987/054/ 200, 200 Suspension for - QJ01RA01 POM: - Procaine Informed - Intramuscular Suspension for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only benzylpenicillin consent use Injection Manufacturing itre Medicine as - application Limited defined in Dihydrostreptom (Article 13c of relevant national ycin Directive No legislation 2001/82/EC)

Chanacycline LA Chanelle VPA10987/023/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular Solution for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only use Injection Manufacturing itre Medicine as Limited defined in relevant national legislation

Chanatol Oral Chanelle VPA10987/033/ 0.099, 99 Oral solution - QA16QA LM: Licensed - Cobalt sulphate - Oral use Solution Pharmaceuticals 001 percent Merchant as heptahydrate Manufacturing weight/volume defined in - Propylene Limited relevant national glycol legislation

Chanaverm Plus Chanelle VPA10987/008/ 1.5 percent Oral solution - QP52AE51 POM: - Levamisole - Oral use Oral Solution Pharmaceuticals 001 weight/volume Prescription Only hydrochloride Manufacturing Medicine as Limited defined in relevant national legislation

Chanazine 10% Chanelle VPA10987/031/ 100 Solution for - QN05CM92 VPO: Veterinary - Xylazine base - Intramuscular Solution for Pharmaceuticals 001 milligram(s)/millil injection Practitioner Only use Injection Manufacturing itre as defined in - Intravenous Limited relevant national use legislation

Chanazine 2% Chanelle VPA10987/030/ 20 Solution for - QN05CM92 VPO: Veterinary - Xylazine base - Intramuscular Solution for Pharmaceuticals 001 milligram(s)/millil injection Practitioner Only use Injection Manufacturing itre as defined in - Intravenous Limited relevant national use legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 39 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Chanectin 0.5% Chanelle VPA10987/154/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin Generic, hybrid - Topical use w/v Pour-on Pharmaceuticals 001 weight/volume Prescription Only or similar Solution Manufacturing Medicine as biological Limited defined in application relevant national (Article 13 of legislation Directive No 2001/82/EC) Chanectin 1 % Chanelle VPA10987/149/ 1.0 percent Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous Solution for Pharmaceuticals 001 weight/volume injection Prescription Only use Injection for Manufacturing Medicine as Cattle Limited defined in relevant national legislation

Chanil 34 mg/ml Chanelle VPA10987/114/ 34 Oral suspension - QP52AG06 POM: - Oxyclozanide Generic - Oral use oral suspension Pharmaceuticals 001 milligram(s)/millil Prescription Only application for cattle Manufacturing itre Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Chanimec 0.5% Chanelle VPA10987/155/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin - Topical use w/v Pour-on Pharmaceuticals 001 weight/volume Prescription Only Solution Manufacturing Medicine as Limited defined in relevant national legislation

CHANIMEC 0.8 Chanelle VPA10987/081/ 0.8 Oral solution - QP54AA01 POM: - Ivermectin Hybrid - Oral use mg/ml Oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application Solution for Manufacturing itre Medicine as (Article 13(3) of Sheep Limited defined in Directive No relevant national 2001/82/EC) legislation

Chanimec 10 Chanelle VPA10987/145/ 10 Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous mg/ml solution Pharmaceuticals 001 milligram(s)/millil injection Prescription Only application use for injection for Manufacturing itre Medicine as (Article 13(1) of Cattle and Pigs Limited defined in Directive No relevant national 2001/82/EC) legislation

Chanimec Super Chanelle VPA10987/091/ 10 Solution for - QP54AA51 POM: - Ivermectin Generic - Subcutaneous Solution for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only - Clorsulon application use Injection Manufacturing itre Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Chanonil Combo Chanelle VPA10987/128/ 134, 120.6 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 134 mg/120.6 Pharmaceuticals 002 mg/pipette Prescription Only - (S)-methoprene application mg Spot-on Manufacturing Medicine as (Article 13(3) of Solution for Limited defined in Directive No Medium Dogs relevant national 2001/82/EC) legislation

Chanonil Combo Chanelle VPA10987/128/ 268, 241.2 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 268 mg/241.2 Pharmaceuticals 003 mg/pipette Prescription Only - (S)-methoprene application mg Spot-on Manufacturing Medicine as (Article 13(3) of Solution for Limited defined in Directive No Large Dogs relevant national 2001/82/EC) legislation

Chanonil Combo Chanelle VPA10987/128/ 402, 361.8 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 402 mg/361.8 Pharmaceuticals 004 mg/pipette Prescription Only - (S)-methoprene application mg Spot-on Manufacturing Medicine as (Article 13(3) of Solution for Extra Limited defined in Directive No Large Dogs relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 40 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Chanonil Combo Chanelle VPA10987/127/ 50, 60 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 50 mg/60 mg Pharmaceuticals 001 mg/pipette Prescription Only - (S)-methoprene application Spot-on Solution Manufacturing Medicine as (Article 13(3) of for Cats and Limited defined in Directive No Ferrets relevant national 2001/82/EC) legislation

Chanonil Combo Chanelle VPA10987/128/ 67, 60.3 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 67 mg/60.3 mg Pharmaceuticals 001 mg/pipette Prescription Only - (S)-methoprene application Spot-on Solution Manufacturing Medicine as (Article 13(3) of for Small Dogs Limited defined in Directive No relevant national 2001/82/EC) legislation

Chanoprim Chanelle VPA10987/029/ 40/200 Solution for - QJ01EW10 POM: - Trimethoprim Informed - Intramuscular Solution for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only - Sulfadiazine consent use Injection Manufacturing itre Medicine as application Limited defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Chanox Multi 50 Chanelle VPA10987/132/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application suspension for Manufacturing itre Medicine as (Article 13(1) of Piglets, Calves Limited defined in Directive No and Lambs relevant national 2001/82/EC) legislation

Chloromed 150 Univet Limited VPA10990/041/ 150 Oral powder - QJ01AA03 POM: - Generic - Oral use mg/g Oral 001 milligram(s)/gra Prescription Only Chlortetracycline application Powder for m Medicine as hydrochloride (Article 13(1) of Calves defined in Directive No relevant national 2001/82/EC) legislation

Chloromed 150 Univet Limited VPA10990/042/ 150 Oral powder - QJ01AA03 POM: - Generic - Oral use mg/g Oral 001 milligram(s)/gra Prescription Only Chlortetracycline application Powder for Pigs m Medicine as hydrochloride (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Chloromed 150 Univet Limited VPA10990/040/ 150 Premix for - QJ01AA03 POM: - Generic - Oral use mg/g Premix for 001 milligram(s)/gra medicated Prescription Only Chlortetracycline application medicated m feeding stuff Medicine as hydrochloride (Article 13(1) of feeding stuff for defined in Directive No calves relevant national 2001/82/EC) legislation

Chloromed 150 Univet Limited VPA10990/043/ 150 Premix for - QJ01AA03 POM: - Generic - Oral use mg/g premix for 001 milligram(s)/gra medicated Prescription Only Chlortetracycline application medicated m feeding stuff Medicine as hydrochloride (Article 13(1) of feeding stuff for defined in Directive No pigs relevant national 2001/82/EC) legislation

Chlorsol 50 % Vetoquinol VPA10983/047/ 50 percent Powder for oral - QJ01AA03 POM: - - Oral use Powder for Oral Ireland Limited 001 weight/weight solution Prescription Only Chlortetracycline Solution Medicine as defined in relevant national legislation

Chorulon 1500 Intervet Ireland VPA10996/021/ 1500 Powder and - QG03GA01 POM: - Chorionic Full application - Intramuscular IU Powder and Limited 001 international solvent for Prescription Only gonadotrophin (Article 12(3) of use solvent for unit(s) solution for Medicine as Directive No - Intravenous solution for injection defined in 2001/82/EC) use injection relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 41 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Chronogest CR Intervet Ireland VPA10996/011/ 20 mg/sponge Medicated - QG03D POM: - Flugestone Full application - Vaginal use 20 mg controlled Limited 001 sponge Prescription Only acetate (Article 12(3) of release vaginal Medicine as Directive No sponge for defined in 2001/82/EC) sheep relevant national legislation

CIDR 1.38 g Zoetis Belgium VPA10387/006/ 1.38 gram(s) Vaginal delivery - QG03DA04 VPO: Veterinary - Progesterone Hybrid - Vaginal use Vaginal Delivery S.A. 001 system Practitioner Only - Progesterone application System for Cattl as defined in (Article 13(3) of relevant national Directive No legislation 2001/82/EC)

Cirbloc emulsion CEVA-Phylaxia VPA10463/001/ . Emulsion for - QI09AA07 POM: - Inactivated Full application - Intramuscular for injection for Veterinary 001 injection Prescription Only antigen of pcv (Article 12(3) of use pigs Biologicals Co. Medicine as type 2b, strain Directive No Ltd defined in rm 2001/82/EC) relevant national legislation

Citramox 1000 Laboratorios VPA10786/005/ 1000 Powder for use - QJ01CA04 POM: - Amoxicillin Hybrid - In drinking mg/g powder for Karizoo S.A. 002 milligram(s)/gra in drinking water Prescription Only trihydrate application water use use in drinking m Medicine as (Article 10(3) of water for defined in Directive No chickens, ducks, relevant national 2001/83/EC) turkeys and pigs legislation

Citramox 500 Laboratorios VPA10786/005/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - Oral use mg/g powder for Karizoo S.A. 001 milligram(s)/gra in drinking water Prescription Only trihydrate application use in drinking m Medicine as (Article 13(1) of water for defined in Directive No chickens, relevant national 2001/82/EC) turkeys, ducks legislation and pigs CITRAMOX L.A. Laboratorios VPA10786/006/ 150 Solution for - QJ01CA04 POM: - Amoxicillin Generic - Intramuscular 150 mg/ml Karizoo S.A. 001 milligram(s)/millil injection Prescription Only trihydrate application use suspension for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle and pigs relevant national 2001/82/EC) legislation

Cladaxxa 200 Krka, d.d., Novo VPA10774/071/ 200,50 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use mg/50 mg mesto 002 Prescription Only trihydrate application chewable tablets Medicine as - Potassium (Article 13(1) of for cats and dog defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Cladaxxa 40 Krka, d.d., Novo VPA10774/071/ 40,10 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use mg/10 mg mesto 001 Prescription Only trihydrate application chewable tablets Medicine as - Potassium (Article 13(1) of for cats and dog defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Cladaxxa 400 Krka, d.d., Novo VPA10774/071/ 400,100 Chewable tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use mg/100 mg mesto 003 mg/tablet Prescription Only trihydrate application chewable tablets Medicine as - Potassium (Article 13(3) of for dogs defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Clavaseptin 250 Vetoquinol VPA10983/048/ 250 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use mg palatable Ireland Limited 002 Prescription Only - Clavulanic acid tablets for dogs Medicine as defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 42 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Clavaseptin 50 Vetoquinol VPA10983/048/ 50 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use mg palatable Ireland Limited 001 Prescription Only - Clavulanic acid tablets for dogs Medicine as and cats defined in relevant national legislation

Clavaseptin 500 Vetoquinol VPA10983/048/ 500 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use mg palatable Ireland Limited 003 Prescription Only - Clavulanic acid tablets for dogs Medicine as defined in relevant national legislation

Clavaseptin 62.5 Vetoquinol VPA10983/048/ 50, 12.5 Tablet - QJ01CR02 POM: - Amoxicillin Well-established - Oral use mg Palatable Ireland Limited 004 mg/tablet Prescription Only - Clavulanic acid use application tablets for dogs Medicine as (Article 13a of and cats defined in Directive No relevant national 2001/82/EC) legislation

Clavubactin Le Vet Beheer VPA10475/014/ 250, 62.5 Tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use 250/62.5 mg B.V. 002 mg/tablet Prescription Only - Clavulanic acid application tablets for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Clavubactin Le Vet Beheer VPA10475/014/ 50, 12.5 Tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use 50/12.5 mg B.V. 001 mg/tablet Prescription Only - Clavulanic acid application tablets for cats Medicine as (Article 13(3) of and dogs defined in Directive No relevant national 2001/82/EC) legislation

Clavubactin Le Vet Beheer VPA10475/014/ 500, 125 Tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use 500/125 mg B.V. 003 mg/tablet Prescription Only - Clavulanic acid application tablets for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Clavucill V.M.D. n.v/s.a. VPA10817/002/ 200, 50 Tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use 200mg/50mg, 002 mg/tablet Prescription Only trihydrate application tablets for dogs Medicine as - Potassium (Article 13(1) of defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Clavucill V.M.D. n.v/s.a. VPA10817/002/ 40, 10 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use 40mg/10mg, 001 Prescription Only trihydrate application tablets for dogs Medicine as - Potassium (Article 13(1) of and cats defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Clavudale 200 Dechra VPA22622/005/ 200, 50 Tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use mg/50 mg tablets Regulatory B.V. 002 mg/tablet Prescription Only trihydrate application for dogs Medicine as - Potassium (Article 13(1) of defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Clavudale 40 Dechra VPA22622/005/ 40, 10 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use mg/10 mg tablets Regulatory B.V. 001 Prescription Only trihydrate application for cats and dog Medicine as - Potassium (Article 13(1) of defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 43 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Clavudale 400 Dechra VPA22622/005/ 400, 100 Tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use mg/100 mg Regulatory B.V. 003 mg/tablet Prescription Only trihydrate application tablets for dogs Medicine as - Potassium (Article 13(1) of defined in clavulanate Directive No relevant national 2001/82/EC) legislation

CLIK 5% Pour- Elanco GmbH VPA22020/021/ 5 percent Pour-on - QP53AX POM: - Dicyclanil Full application - Topical use on Suspension 001 weight/volume suspension Prescription Only (Article 12(3) of for Sheep Medicine as Directive No defined in 2001/82/EC) relevant national legislation

CLiK Extra 65 Elanco GmbH VPA22020/022/ 65 Pour-on - QP53AX24 POM: - Dicyclanil Full application - Topical use mg/ml Pour-On 001 milligram(s)/millil suspension Prescription Only (Article 12(3) of Suspension for itre Medicine as Directive No Sheep defined in 2001/82/EC) relevant national legislation

CLiKZiN 12.5 Elanco GmbH VPA22020/023/ 12.5 Pour-on - QP53AX24 POM: - Dicyclanil Full application - Topical use mg/ml Pour-On 001 milligram(s)/millil suspension Prescription Only (Article 12(3) of Suspension for itre Medicine as Directive No Sheep defined in 2001/82/EC) relevant national legislation

Clinacin 150 mg Chanelle VPA10987/144/ 150 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin - Oral use Tablets for Dogs Pharmaceuticals 003 Prescription Only hydrochloride Manufacturing Medicine as Limited defined in relevant national legislation

Clinacin 25 mg Chanelle VPA10987/144/ 25 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Well-established - Oral use Tablets Pharmaceuticals 004 Prescription Only (as clindamycin use application Manufacturing Medicine as hydrochloride) (Article 13a of Limited defined in Directive No relevant national 2001/82/EC) legislation

Clinacin 25 mg Chanelle VPA10987/144/ 25 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin - Oral use Tablets for Dogs Pharmaceuticals 002 Prescription Only hydrochloride Manufacturing Medicine as Limited defined in relevant national legislation

Clinacin 300 mg Chanelle VPA10987/144/ 300 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Well-established - Oral use Tablets for Dogs Pharmaceuticals 005 Prescription Only hydrochloride use application Manufacturing Medicine as (Article 13a of Limited defined in Directive No relevant national 2001/82/EC) legislation

Clinacin 75 mg Chanelle VPA10987/144/ 75 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin - Oral use Tablets for Dogs Pharmaceuticals 001 Prescription Only hydrochloride Manufacturing Medicine as Limited defined in relevant national legislation

Clindabactin 220 Dechra VPA22622/028/ 220 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Hybrid - Oral use mg chewable Regulatory B.V. 001 Prescription Only application tablets for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 44 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Clindabactin 440 Dechra VPA22622/028/ 440 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Hybrid - Oral use mg chewable Regulatory B.V. 002 Prescription Only application tablets for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Clindabactin 55 Dechra VPA22622/027/ 55 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Hybrid - Oral use mg chewable Regulatory B.V. 001 Prescription Only application tablets for dogs Medicine as (Article 13(3) of and cats defined in Directive No relevant national 2001/82/EC) legislation

Clindacutin 10 Dechra VPA22622/031/ 10 Ointment - QD06AX POM: - Clindamycin Hybrid - Cutaneous use mg/g ointment Regulatory B.V. 001 milligram(s)/gra Prescription Only application for dogs m Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Clindacyl 150 mg Vetoquinol VPA10983/049/ 150 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Informed - Oral use Tablets for Dogs Ireland Limited 003 Prescription Only hydrochloride consent Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Clindacyl 25 mg Vetoquinol VPA10983/049/ 25 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Informed - Oral use Tablets for dogs Ireland Limited 001 Prescription Only hydrochloride consent and cats Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Clindacyl 300 mg Chanelle VPA10987/161/ 300 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Well-established - Oral use Tablets for Dogs Pharmaceuticals 001 Prescription Only (as clindamycin use application Manufacturing Medicine as hydrochloride) (Article 13a of Limited defined in Directive No relevant national 2001/82/EC) legislation

Clindacyl 75 mg Vetoquinol VPA10983/049/ 75 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Informed - Oral use Tablets for dogs Ireland Limited 002 Prescription Only hydrochloride consent Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Clindaseptin 150 Chanelle VPA10987/163/ 150 Milligrams Capsule - QJ01FF01 POM: - Clindamycin Full application - Oral use mg capsules for Pharmaceuticals 003 per capsule Prescription Only hydrochloride (Article 12(3) of dogs Manufacturing Medicine as Directive No Limited defined in 2001/82/EC) relevant national legislation

Clindaseptin 25 Chanelle VPA10987/163/ 25 Milligrams per Capsule - QJ01FF01 POM: - Clindamycin Full application - Oral use mg capsules for Pharmaceuticals 001 capsule Prescription Only hydrochloride (Article 12(3) of dogs Manufacturing Medicine as Directive No Limited defined in 2001/82/EC) relevant national legislation

Clindaseptin 25 Chanelle VPA10987/097/ 25 Oral solution - QJ01FF01 POM: - Clindamycin Generic - Oral use mg/ml oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application solution for cats Manufacturing itre Medicine as (Article 13(1) of and dogs Limited defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 45 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Clindaseptin 300 Chanelle VPA10987/163/ 300 Milligrams Capsule - QJ01FF01 POM: - Clindamycin Full application - Oral use mg capsules for Pharmaceuticals 004 per capsule Prescription Only hydrochloride (Article 12(3) of dogs Manufacturing Medicine as Directive No Limited defined in 2001/82/EC) relevant national legislation

Clindaseptin 75 Chanelle VPA10987/163/ 75 Milligrams per Capsule - QJ01FF01 POM: - Clindamycin Full application - Oral use mg capsules for Pharmaceuticals 002 capsule Prescription Only hydrochloride (Article 12(3) of dogs Manufacturing Medicine as Directive No Limited defined in 2001/82/EC) relevant national legislation

Closamectin 5 Norbrook VPA22664/088/ 5, 200 Pour-on solution - QP54AA51 POM: - Ivermectin Full application - Topical use mg/ml + 200 Laboratories 001 milligram(s)/millil Prescription Only - Closantel (Article 12(3) of mg/ml Pour-On (Ireland) Limited itre Medicine as sodium Directive No Solution for defined in 2001/82/EC) Cattle relevant national legislation

Closamectin Norbrook VPA22664/083/ 5, 125 Solution for - QP54AA51 POM: - Ivermectin Fixed - Subcutaneous Solution for Laboratories 001 milligram(s)/millil injection Prescription Only - Closantel combination use Injection for (Ireland) Limited itre Medicine as sodium dihydrate application Cattle and defined in (Article 13b of Sheep relevant national Directive No legislation 2001/82/EC)

Closiver 5 Norbrook VPA22664/084/ 5, 125 Solution for - QP54AA51 POM: - Ivermectin Fixed - Subcutaneous mg/ml/125 mg/ml Laboratories 001 milligram(s)/millil injection Prescription Only - Closantel combination use Solution for (Ireland) Limited itre Medicine as sodium dihydrate application Injection for defined in (Article 13b of Cattle and relevant national Directive No Sheep legislation 2001/82/EC)

Closivet 5 mg/ml Norbrook VPA22664/102/ 5, 200 Pour-on solution - QP54AA51 POM: - Ivermectin Informed - Topical use + 200 mg/ml Laboratories 001 milligram(s)/millil Prescription Only - Closantel consent Pour-On Solution (Ireland) Limited itre Medicine as sodium dihydrate application for Cattle defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Cobactan 2.5% Intervet Ireland VPA10996/104/ 2.5 percent Suspension for - QJ01DE90 POM: - Cefquinome Full application - Intramuscular w/v Suspension Limited 001 weight/volume injection Prescription Only sulphate (Article 12(3) of use for Injection Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Cobactan LC, 75 Intervet Ireland VPA10996/105/ 75 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Full application - Intramammary mg, Limited 001 ointment Prescription Only sulphate (Article 12(3) of use intramammary Medicine as Directive No ointment for defined in 2001/82/EC) lactating cattle relevant national legislation

Cobalt Super Chanelle VPA10987/032/ 2.1 Oral solution - QV06D LM: Licensed - Cobalt sulphate - Oral use Oral Solution Pharmaceuticals 001 milligram(s)/millil Merchant as heptahydrate 2.1mg/ml Manufacturing itre defined in Limited relevant national legislation

Coccibal 400 SP Veterinaria, VPA10790/012/ 400 Solution for use - QP51AX09 POM: - Amprolium Hybrid - In drinking mg/ml solution S.A. 002 milligram(s)/millil in drinking water Prescription Only hydrochloride application water use for use in itre Medicine as (Article 13(3) of drinking water defined in Directive No for chickens and relevant national 2001/82/EC) turkeys legislation

Coccibal, 200 SP Veterinaria, VPA10790/012/ 200 Oral solution - QP51AX09 POM: - Amprolium (as Hybrid - Oral use mg/ml solution S.A. 001 milligram(s)/millil Prescription Only hydrochloride) application for use in itre Medicine as (Article 13(3) of drinking water for defined in Directive No chicken and relevant national 2001/82/EC) turkeys legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 46 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Coglapix Ceva Santé VPA10815/030/ . Suspension for - QI09AB07 POM (E): - Actinobacillus Full application - Intramuscular suspension for Animale 001 injection Prescription Only pleuropneumoni (Article 12(3) of use injection for pigs. Exempt as ae strain nt3 Directive No defined in - Actinobacillus 2001/82/EC) relevant national pleurpneumonia legislation e strain szii - Actinobacillus pleuropneumoni ae strain po - Actinobacillus pleuropneumoni ae strain u3 - Actinobacillus pleuropneumoni ae strain b4 Colfive LIVISTO Int'l, VPA10425/001/ 5,000,000 Oral solution - QA07AA10 POM: - Colistin sulfate Hybrid - Oral use 5,000,000 IU/ml S.L. 001 international Prescription Only application concentrate for unit(s)/millilitre Medicine as (Article 13(3) of oral solution for defined in Directive No calves, pigs, relevant national 2001/82/EC) lambs, chickens legislation and turkeys Coliscour 2 000 Ceva Santé VPA10815/006/ 2,000,000 Oral solution - QA07AA10 POM: - Colistin Generic - Oral use 000 IU/ml, Animale 001 international Prescription Only application concentrate for unit(s)/millilitre Medicine as (Article 13(1) of oral solution, defined in Directive No pigs, poultry relevant national 2001/82/EC) legislation

COLMYC 25 SP Veterinaria, VPA10790/003/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml ORAL S.A. 001 milligram(s)/millil Prescription Only application SOLUTION for itre Medicine as (Article 13(1) of calves defined in Directive No relevant national 2001/82/EC) legislation

Colombovac Zoetis Belgium VPA10387/007/ . Suspension for - QI01EA01 POM (E): - Inactivated Full application - Subcutaneous PMV S.A. 001 injection Prescription Only newcastle (Article 12(3) of use Exempt as disease virus Directive No defined in strain la sota 2001/82/EC) relevant national legislation

Colvasone 2 Norbrook VPA22664/028/ 2 Solution for - QH02AB02 POM: - Full application - Intramuscular mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only Dexamethasone (Article 12(3) of use for injection (Ireland) Limited itre Medicine as sodium Directive No - Intravenous defined in phosphate 2001/82/EC) use relevant national legislation

Combiclav Norbrook VPA22664/143/ 200, 50, 10 Intramammary - QJ51RV01 POM: - Amoxicillin Hybrid - Intramammary Intramammary Laboratories 001 mg/syringe suspension Prescription Only trihydrate application use Suspension for (Ireland) Limited Medicine as - Prednisolone (Article 13(3) of Lactating Cows defined in - Potassium Directive No relevant national clavulanate 2001/82/EC) legislation

Combizole Oral Bimeda Animal VPA22033/006/ 25.0/37.5 Oral suspension - QP52A POM: - Fenbendazole Informed - Oral use Suspension Health Limited 001 milligram(s)/millil Prescription Only - Levamisole consent itre Medicine as hydrochloride application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Comfortan 10 Eurovet Animal VPA10989/069/ 10 Solution for - QN02AC90 VPO: Veterinary - Methadone Hybrid - Intramuscular mg/ml solution Health B.V. 001 milligram(s)/millil injection Practitioner Only application use for injection for itre as defined in (Article 13(3) of - Intravenous dogs and cats relevant national Directive No use legislation 2001/82/EC) - Subcutaneous use

Veterinary Medicines Authorised/Transfer Pending Products Page 47 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration CONTINENCE FATRO S.p.A. VPA10836/008/ 40 Syrup - QG04BX91 POM: - Generic - Per Oral 40 mg/ml syrup 001 milligram(s)/millil Prescription Only Phenylpropanol application for dogs itre Medicine as amine (Article 13(1) of defined in hydrochloride Directive No relevant national 2001/82/EC) legislation

Co-op Teat Dip Kilco Chemicals VPA10929/001/ 20 Teat dip/spray - QD08AG03 LM: Licensed - Iodine Informed - Topical use (Ire.) Limited 001 milligram(s)/millil solution Merchant as consent itre defined in application relevant national (Article 13c of legislation Directive No 2001/82/EC) Copasure 2 g Animax Limited VPA10834/001/ 2 g/capsule Capsule - QA12C LM: Licensed - Copper oxide ZZZ Complete - Oral use capsules 001 Merchant as application defined in (stand-alone) - relevant national Council Directive legislation 81/851/EEC

Copasure 27g Animax Limited VPA10834/001/ 27 g/capsule Capsule, hard - QA12C LM: Licensed - Copper oxide ZZZ Complete - Oral use Capsules 003 Merchant as application defined in (stand-alone) - relevant national Council Directive legislation 81/851/EEC

Copasure 4g Animax Limited VPA10834/001/ 4 g/capsule Capsule - QA12C LM: Licensed - Copper oxide ZZZ Complete - Oral use Capsules 002 Merchant as application defined in (stand-alone) - relevant national Council Directive legislation 81/851/EEC

Copinox 27g Animax Limited VPA10834/002/ 27 g/capsule Capsule, hard - QA12C LM: Licensed - Copper oxide ZZZ Complete - Oral use Capsules 001 Merchant as application defined in (stand-alone) - relevant national Council Directive legislation 81/851/EEC

Copper 20 mg/ml Ballinskelligs VPA10956/005/ 20 Suspension for - QA12CX LM: Licensed - Copper ZZZ Complete - Intramuscular Suspension for Vet. Products Lt 002 milligram(s)/millil injection Merchant as methionate application use Injection itre defined in (stand-alone) - relevant national Council Directive legislation 81/851/EEC

CORTEXONAV Laboratorios VPA10495/005/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular ET 2 mg/ml SYVA, S.A.U 001 milligram(s)/millil injection Prescription Only Dexamethasone application use solution for itre Medicine as sodium (Article 13(1) of - Intramuscular injection for defined in phosphate Directive No use cattle, horses, relevant national 2001/82/EC) - Intravenous pigs, dogs and legislation use cats Cortico Veyxin Veyx-Pharma VPA10539/006/ 10.0 Suspension for - QH02AB06 POM: - Prednisolone Hybrid - Intramuscular 10 mg/ml GmbH 001 milligram(s)/millil injection Prescription Only acetate application use suspension for itre Medicine as (Article 13(3) of injection for defined in Directive No cattle, horses, relevant national 2001/82/EC) dogs and cats legislation

Cosacthen 0.25 Dechra VPA22622/001/ 0.25 Solution for - QH01AA02 VPO: Veterinary - Well-established - Intramuscular mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Practitioner Only TETRACOSAC use application use for injection for itre as defined in TIDE (Article 13a of - Intravenous dogs relevant national HEXAACETATE Directive No use legislation 2001/82/EC)

Cosecure Cattle Bimeda Animal VPA22033/054/ 13.4, 0.5, 0.3 Continuous- - QA12CE99 LM: Licensed - Copper Full application - Oral use Bolus Health Limited 001 gram/100gram release Merchant as - Cobalt (Article 12(3) of Continuous intraruminal defined in - Sodium Directive No Release device relevant national selenate 2001/82/EC) Intraruminal legislation Device

Veterinary Medicines Authorised/Transfer Pending Products Page 48 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Co-Trimoxazole Kela n.v. VPA10981/001/ 24 percent Solution for - QJ01EW POM: - - Intramuscular 24% w/v solution 001 weight/volume injection Prescription Only Sulfamethoxazo use for injection Medicine as le defined in - Trimethoprim relevant national legislation

Covexin 10 Zoetis Belgium VPA10387/008/ . Suspension for - QI02AB01 LM: Licensed - C. Full application - Subcutaneous Suspension for S.A. 001 injection - QI04AB01 Merchant as haemolyticum (Article 12(3) of use injection for defined in toxoid (strain cn Directive No sheep and cattle relevant national 3629) 2001/82/EC) legislation - 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 d toxoid (strain cn 3688) - C. perfringens type c toxoid (strain cn 883) - C. perfringens type b toxoid (strain cn 1240) - C. perfringens type a toxoid (strain cn 1491)

Covexin 8 Zoetis Belgium VPA10387/009/ . Suspension for - QI02AB01 LM: Licensed - C. perfringens Full application - Subcutaneous Suspension for S.A. 001 injection - QI04AB01 Merchant as type b & c ß (Article 12(3) of use injection for defined in toxoid Directive No sheep and cattle relevant national - C. perfringens 2001/82/EC) legislation type d (e) toxoid - C. chauvoei whole culture - C. novyi type B anaculture - C. septicum toxoid - C. tetani toxoid - C. haemolyticum anaculture

Coxaclear 50 Krka, d.d., Novo VPA10774/008/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml oral mesto 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(1) of pigs, cattle and defined in Directive No sheep relevant national 2001/82/EC) legislation

Coxx-Kure 50 LAPROVET VPA10483/002/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml oral 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(1) of piglets and defined in Directive No calves relevant national 2001/82/EC) legislation

Cronyxin 50 Bimeda Animal VPA22033/034/ 50 Oral paste - QM01AG90 POM: - Flunixin Generic - Oral use mg/g Oral paste Health Limited 001 milligram(s)/gra Prescription Only application for horses m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 49 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Cronyxin Bimeda Animal VPA22033/040/ 50 Solution for - QM01AG90 POM: - Flunixin ZZZ Informed - Intravenous Injection 50 Health Limited 001 milligram(s)/millil injection Prescription Only meglumine consent use mg/ml Solution itre Medicine as (abridged for Injection defined in application) - relevant national Council Directive legislation 81/851/EEC

Cryomarex Boehringer VPA10454/030/ . Suspension for - QI01AD03 POM: - Marek disease Full application - Intramuscular Rispens Ingelheim 001 injection Prescription Only virus (rispens (Article 12(3) of use Vetmedica Medicine as strain) Directive No - Subcutaneous GmbH defined in 2001/82/EC) use relevant national legislation

Cryptisel 0.5 LIVISTO Int'l, VPA10425/015/ 0.5 Oral solution - QP51AX08 POM: - Halofuginone Generic - Oral use mg/ml oral S.L. 001 milligram(s)/millil Prescription Only Base (As lactate application solution for itre Medicine as salt) (Article 13(1) of calves defined in Directive No relevant national 2001/82/EC) legislation

CTC 10 %w/w Univet Limited VPA10990/018/ 10 percent Oral powder - QJ01AA03 POM: - - Oral use Oral Powder 001 weight/weight Prescription Only Chlortetracycline Medicine as hydrochloride defined in relevant national legislation

CTC 10 %w/w Univet Limited VPA10990/039/ 10
percent Premix for - QJ01AA03 POM: - Full application - Oral use Premix for 001 weight/weight medicated Prescription Only Chlortetracycline (Article 12(3) of Medicated Feed feeding stuff Medicine as hydrochloride Directive No defined in 2001/82/EC) relevant national legislation

CTC 15 %w/w Univet Limited VPA10990/039/ 15
percent Premix for - QJ01AA03 POM: - Full application - Oral use Premix for 002 weight/weight medicated Prescription Only Chlortetracycline (Article 12(3) of Medicated Feed feeding stuff Medicine as hydrochloride Directive No defined in 2001/82/EC) relevant national legislation

CTC 15% w/w Univet Limited VPA10990/034/ 15 percent Oral powder - QJ01AA03 POM: - Full application - Oral use Oral Powder 001 weight/weight Prescription Only Chlortetracycline (Article 12(3) of Medicine as hydrochloride Directive No defined in 2001/82/EC) relevant national legislation

Curacef duo, 50 Virbac S.A. VPA10988/092/ 50,100 Suspension for - QJ01DD POM: - Ceftiofur Fixed - Intramuscular mg/ml / 150 001 milligram(s)/millil injection Prescription Only - Ketoprofen combination use mg/ml, itre Medicine as application Suspension for defined in (Article 13b of Injection for relevant national Directive No Cattle legislation 2001/82/EC)

Curafluke 10% Univet Limited VPA10990/032/ 100, 100 Oral suspension - QP52AC30 POM: - Fenbendazole Full application - Oral use w/v Oral Drench 002 milligram(s)/millil Prescription Only - Rafoxanide (Article 12(3) of itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Curafluke 5% Univet Limited VPA10990/032/ 50 / 50 Oral suspension - QP52AC30 POM: - Fenbendazole Full application - Oral use w/v Oral Drench 001 milligram(s)/millil Prescription Only - Rafoxanide (Article 12(3) of itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 50 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Curazole 10 Univet Limited VPA10990/015/ 10 percent Oral suspension - QP52AC13 POM: - Fenbendazole - Oral use %w/v Oral 001 weight/volume Prescription Only Drench Medicine as defined in relevant national legislation

Curazole 2.5% Univet Limited VPA10990/015/ 2.5 percent Oral suspension - QP52AC13 POM: - Fenbendazole - Oral use w/v Oral Drench 002 weight/volume Prescription Only Medicine as defined in relevant national legislation

Curazole 5 %w/v Univet Limited VPA10990/015/ 5 percent Oral suspension - QP52AC13 POM: - Fenbendazole - Oral use Oral Drench 003 weight/volume Prescription Only Medicine as defined in relevant national legislation

Curazole 5% Univet Limited VPA10990/030/ 5 percent Premix for - QP52AC13 POM: - Fenbendazole - Oral use w/w Premix for 001 weight/weight medicated Prescription Only Medicated Feed feeding stuff Medicine as defined in relevant national legislation

Curazole 50 Univet Limited VPA10990/044/ 50 Oral powder - QP52AC13 POM: - Fenbendazole Full application - Oral use mg/g oral 001 milligram(s)/gra Prescription Only (Article 12(3) of powder for pigs m Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Curofen 50 mg/g Univet Limited VPA10990/045/ 50 Oral powder - QP52AC13 POM: - Fenbendazole Generic - Oral use oral powder for 001 milligram(s)/gra Prescription Only application pigs m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Curofen 50 mg/g Univet Limited VPA10990/046/ 50 Premix for - QP52AC13 POM: - Fenbendazole Generic - Oral use Premix for 001 milligram(s)/gra medicated Prescription Only application Medicated m feeding stuff Medicine as (Article 13(1) of Feeding Stuff for defined in Directive No Pigs relevant national 2001/82/EC) legislation

Cyclavance 100 Virbac S.A. VPA10988/094/ 100 Oral solution - QL04A POM: - Ciclosporin Generic - Oral use mg/ml oral 001 milligram(s)/millil Prescription Only application solution for dogs itre Medicine as (Article 13(1) of and cats defined in Directive No relevant national 2001/82/EC) legislation

Cyclio 12 mg Virbac S.A. VPA10988/061/ 12 mg/pipette Spot-on solution - QP53AX23 POM: - Pyriproxyfen - Topical use Spot-on Solution 001 Prescription Only For Small Dogs Medicine as defined in relevant national legislation

Cyclio 30 mg Virbac S.A. VPA10988/061/ 30 mg/pipette Spot-on solution - QP53AX23 POM: - Pyriproxyfen - Topical use Spot-on Solution 002 Prescription Only for Medium Medicine as Sized Dogs defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 51 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Cyclio 60 mg Virbac S.A. VPA10988/060/ 60 mg/pipette Spot-on solution - QP53AX23 POM: - Pyriproxyfen - Topical use Spot-on Solution 001 Prescription Only for Cats Medicine as defined in relevant national legislation

Cyclio 60 mg Virbac S.A. VPA10988/061/ 60 mg/pipette Spot-on solution - QP53AX23 POM: - Pyriproxyfen - Topical use Spot-on Solution 003 Prescription Only for Large Dogs Medicine as defined in relevant national legislation

Cyclix 250 Virbac S.A. VPA10988/079/ 250 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular microgram/ml 001 microgram(s)/mil injection Prescription Only sodium application use solution for lilitre Medicine as (Article 13(1) of injection for defined in Directive No cattle relevant national 2001/82/EC) legislation

Cyclix porcine Virbac S.A. VPA10988/080/ 87.5 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular 87.5 001 microgram(s)/mil injection Prescription Only sodium application use microgram/ml lilitre Medicine as (Article 13(1) of solution for defined in Directive No injection relevant national 2001/82/EC) legislation

Cyclo Spray, Eurovet Animal VPA10989/049/ 2.45 percent Cutaneous - QD06A POM: - - Topical use 2.45 % w/w for Health B.V. 001 weight/weight spray, Prescription Only Chlortetracycline cattle, sheep and suspension Medicine as hydrochloride pigs defined in relevant national legislation

Cyclosol LA 200 Eurovet Animal VPA10989/026/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline ZZZ Informed - Intramuscular mg/ml Solution Health B.V. 001 milligram(s)/millil injection Prescription Only dihydrate consent use for Injection itre Medicine as (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

Cydectin 0.1% Zoetis Belgium VPA10387/011/ 0.1 percent Oral solution - QP54AB02 POM: - Moxidectin Full application - Oral use w/v oral solution S.A. 001 weight/volume Prescription Only (Article 12(3) of for sheep Medicine as Directive No defined in 2001/82/EC) relevant national legislation

CYDECTIN 0.5% Zoetis Belgium VPA10387/012/

5.00

Pour-on solution - QP54AB02 POM: - Moxidectin Full application - Topical use w/v Pour-On for S.A. 001 milligram(s) Prescription Only (Article 12(3) of cattle Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Cydectin 1 % w/v Zoetis Belgium VPA10387/013/ 1 percent Solution for - QP54AB02 POM: - Moxidectin Full application - Subcutaneous Solution for S.A. 001 weight/volume injection Prescription Only (Article 12(3) of use injection for Medicine as Directive No cattle defined in 2001/82/EC) relevant national legislation

Cydectin 1% w/v Zoetis Belgium VPA10387/014/ 1 percent Solution for - QP54AB02 POM: - Moxidectin Full application - Subcutaneous Injectable S.A. 001 weight/volume injection Prescription Only (Article 12(3) of use Solution for Medicine as Directive No Sheep defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 52 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Cydectin 10 % Zoetis Belgium VPA10387/015/ 10 percent Solution for - QP54AB02 POM: - Moxidectin Full application - Subcutaneous LA Solution for S.A. 001 weight/volume injection Prescription Only (Article 12(3) of use Injection for Medicine as Directive No Cattle defined in 2001/82/EC) relevant national legislation

Cydectin 20 Zoetis Belgium VPA10387/095/ 20 Solution for - QP54AB02 POM: - Moxidectin Full application - Subcutaneous mg/ml LA S.A. 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use Solution for itre Medicine as Directive No Injection for defined in 2001/82/EC) Sheep relevant national legislation

Cydectin Zoetis Belgium VPA10387/016/ 1/50 Oral solution - QP54AB52 POM: - Moxidectin Fixed - Oral use TriclaMox S.A. 001 milligram(s)/millil Prescription Only - Triclabendazole combination 1mg/ml + 50 itre Medicine as application mg/ml Oral defined in (Article 13b of Solution for relevant national Directive No sheep legislation 2001/82/EC)

Cydectin Zoetis Belgium VPA10387/017/ 5/200 Pour-on solution - QP54AB52 POM: - Moxidectin Fixed - Cutaneous use TriclaMox 5 S.A. 001 milligram(s)/millil Prescription Only - Triclabendazole combination mg/ml + 200 itre Medicine as application mg/ml Pour-on defined in (Article 13b of Solution for relevant national Directive No cattle legislation 2001/82/EC)

Cylanic 250 mg LIVISTO Int'l, VPA10425/017/ 250/62.5 Tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Per Oral + 62.5 mg tablets S.L. 002 mg/tablet Prescription Only trihydrate application for dogs and cat Medicine as - Potassium (Article 13(3) of defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Cylanic 50 mg + LIVISTO Int'l, VPA10425/017/ 50/12.5 Tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Per Oral 12.5 mg tablets S.L. 001 mg/tablet Prescription Only trihydrate application for dogs and cat Medicine as - Potassium (Article 13(3) of defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Cylanic 500 mg LIVISTO Int'l, VPA10425/017/ 500/125 Tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Per Oral + 125 mg tablets S.L. 003 mg/tablet Prescription Only trihydrate application for dogs Medicine as - Potassium (Article 13(3) of defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Cypercare Medivet Limited VPA10887/002/ 2.5 percent Pour-on solution - QP53AC POM: - Cypermethrin - Topical use 2.5%w/v Pour-on 001 weight/volume Prescription Only technical (93%) Solution Medicine as (cis: trans 50:50) defined in relevant national legislation

Cyperguard Bimeda Animal VPA22033/007/ 10 percent Concentrate for - QP53AC08 POM: - Cypermethrin Informed - Topical use Concentrate for Health Limited 001 weight/weight dip suspension Prescription Only high cis consent Dip Emulsion Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

CZV Avian CZ Veterinaria, VPA10784/001/ 25000 Solution for - QI02AR02 VPO: Veterinary - Purified protein Full application - Intradermal use Tuberculin PPD S.A. 001 international injection Practitioner Only derivative from (Article 12(3) of unit(s)/millilitre as defined in culture of Directive No relevant national Mycobacterium 2001/82/EC) legislation avium, subsp. avium strain D4 ER

Veterinary Medicines Authorised/Transfer Pending Products Page 53 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration CZV BOVINE CZ Veterinaria, VPA10784/002/ 2500 Solution for - QI02AR01 VPO: Veterinary - Purified protein Full application - Intradermal use TUBERCULIN S.A. 001 International injection Practitioner Only derivative from (Article 12(3) of PPD, solution for Units/dose as defined in culture of Directive No injection relevant national mycobacterium 2001/82/EC) legislation bovis, strain an-5

Dalmaprost FATRO S.p.A. VPA10836/009/ 0.075 Solution for - QG02AD90 POM: - d-Cloprostenol Generic - Intramuscular 0.075 mg/ml 001 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle, pigs and relevant national 2001/82/EC) horses legislation

DALMARELIN, FATRO S.p.A. VPA10836/002/ 25 Solution for - QH01CA92 POM: - Lecirelin Full application - Intramuscular 25 001 microgram(s)/mil injection Prescription Only (Article 12(3) of use micrograms/ml, lilitre Medicine as Directive No solution for defined in 2001/82/EC) injection for relevant national cattle and rabbit legislation

Dalmazin 75 FATRO S.p.A. VPA10836/001/ 75 Solution for - QG02AD90 POM: - d-Cloprostenol - Intramuscular micrograms/ml 001 microgram(s)/mil injection Prescription Only use solution for lilitre Medicine as injection for cows defined in and sows relevant national legislation

Deccox 60.6 Zoetis Belgium VPA10387/018/ 60.6 Premix for - QP51AX14 POM: - Decoquinate - Oral use g/kg Premix for S.A. 001 gram(s)/kilogra medicated Prescription Only Medicated m(s) feeding stuff Medicine as Feeding Stuff defined in relevant national legislation

DECTOMAX 10 Zoetis Belgium VPA10387/019/ 10 Solution for - QP54AA03 POM: - Doramectin Generic - Intramuscular mg/ml Solution S.A. 001 milligram(s)/millil injection Prescription Only application use for Injection for itre Medicine as (Article 13(1) of - Subcutaneous Cattle, Sheep defined in Directive No use and Pigs relevant national 2001/82/EC) legislation

Dectomax 5 Zoetis Belgium VPA10387/020/ 5 Pour-on solution - QP54AA03 POM: - Doramectin Generic - Topical use mg/ml Pour-On S.A. 001 milligram(s)/millil Prescription Only application Solution for itre Medicine as (Article 13(1) of Cattle defined in Directive No relevant national 2001/82/EC) legislation

Dectospot 10 Bimeda Animal VPA22033/058/ 10 Pour-on solution - QP53AC11 POM: - Deltamethrin Generic - Topical use mg/ml Pour-on Health Limited 001 milligram(s)/millil Prescription Only application Solution for itre Medicine as (Article 13(1) of Cattle and defined in Directive No Sheep relevant national 2001/82/EC) legislation

Defendog Virbac S.A. VPA10988/053/ 1.88 grams/100 Cutaneous - QP53AC04 CAM: - Permethrin - Topical use Cutaneous 001 millilitres solution Companion technical (40:60) solution Animal Medicine as defined in relevant national legislation

Delta Acravet Ltd VPA10793/001/ 3 Solution for - QV03AB07 VPO: Veterinary - Apomorphine 12(3) full dossier - Subcutaneous Apomorphine 001 milligram(s)/millil injection Practitioner Only hydrochloride Hydrochloride itre as defined in Solution for relevant national Injection 3 mg/ml legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 54 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Deltadot 10 Bimeda Animal VPA22033/008/ 10 Pour-on solution - QP53AC11 POM: - Deltamethrin Generic - Pour-on use mg/ml Pour-on Health Limited 001 milligram(s)/millil Prescription Only application Solution for itre Medicine as (Article 13(1) of Cattle and defined in Directive No Sheep relevant national 2001/82/EC) legislation

Deltanil 10 Virbac S.A. VPA10988/087/ 10 Cutaneous - QP53AC11 POM: - Deltamethrin Hybrid - Topical use mg/ml Pour-on 001 milligram(s)/millil solution Prescription Only application Solution for itre Medicine as (Article 13(3) of cattle and sheep defined in Directive No relevant national 2001/82/EC) legislation

Delvosteron 100 Intervet Ireland VPA10996/065/ 100 Suspension for - QG03DA90 POM: - Proligestone Full application - Subcutaneous mg/ml Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use Suspension for itre Medicine as Directive No Injection defined in 2001/82/EC) relevant national legislation

Depocillin 300 Intervet Ireland VPA10996/068/ 300 Suspension for - QJ01CE09 POM: - Procaine - Intramuscular mg/ml Limited 001 milligram(s)/millil injection Prescription Only benzylpenicillin use Suspension for itre Medicine as - Subcutaneous Injection defined in use relevant national legislation

Depo-Medrone V Zoetis Belgium VPA10387/021/ 40 Suspension for - QH02AB04 POM: - Full application - Intramuscular 40 mg/ml S.A. 001 milligram(s)/millil injection Prescription Only Methylprednisol (Article 12(3) of use Suspension for itre Medicine as one acetate Directive No - ZZZ Injection defined in 2001/82/EC) Intrasynovial relevant national legislation

Dermanolon 1.77 Le Vet Beheer VPA10475/026/ 1.77,17.7 Cutaneous - QD07XB02 POM: - Triamcinolone Generic - Cutaneous use mg/ml + 17.7 B.V. 001 milligram(s)/millil spray, solution Prescription Only acetonide application mg/ml cutaneous itre Medicine as - Salicylic acid (Article 13(1) of spray, solution defined in Directive No for dogs and cat relevant national 2001/82/EC) legislation

Dermipred 10 Ceva Santé VPA10815/029/ 10 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Generic - Oral use mg tablets for Animale 002 Prescription Only application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Dermipred 20 Ceva Santé VPA10815/029/ 20 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Hybrid - Oral use mg tablets for Animale 003 Prescription Only application dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Dermipred 5 mg Ceva Santé VPA10815/029/ 5 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Hybrid - Oral use tablets for dogs Animale 001 Prescription Only application Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

DETOGESIC 10 Vetcare Limited VPA10789/001/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomidine Hybrid - Intravenous mg/ml Solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for Injection for itre as defined in (Article 13(3) of Horses relevant national Directive No legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 55 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Detonervin 10 Le Vet BV VPA10816/010/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomidine Generic - Intramuscular mg/ml, solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for itre as defined in (Article 13(1) of - Intravenous Horses and relevant national Directive No use Cattle legislation 2001/82/EC)

Dexacortone 0.5 Le Vet Beheer VPA10475/035/ 0.5 mg/tablet Chewable tablet - QH02AB02 POM: - Generic - Oral use mg chewable B.V. 001 Prescription Only Dexamethasone application tablets for dogs Medicine as (Article 13(1) of and cats defined in Directive No relevant national 2001/82/EC) legislation

Dexacortone 2.0 Le Vet Beheer VPA10475/035/ 2 mg/tablet Chewable tablet - QH02AB02 POM: - Generic - Oral use mg chewable B.V. 002 Prescription Only Dexamethasone application tablets for dogs Medicine as (Article 13(1) of and cats defined in Directive No relevant national 2001/82/EC) legislation

Dexadreson 2 Intervet Ireland VPA10996/027/ 2 Solution for - QH02AB02 POM: - Full application - Intraarticular mg/ml solution Limited 001 milligram(s)/millil injection Prescription Only Dexamethasone (Article 12(3) of use for injection itre Medicine as sodium Directive No - Intramuscular defined in phosphate 2001/82/EC) use relevant national - Intravenous legislation use

Dexafast 2 LIVISTO Int'l, VPA10425/008/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular mg/ml solution S.L. 001 milligram(s)/millil injection Prescription Only Dexamethasone application use for injection for itre Medicine as sodium (Article 13(1) of - Intramuscular horses, cattle, defined in phosphate Directive No use pigs, dogs and relevant national 2001/82/EC) - Intravenous cats legislation use

Dexafort Intervet Ireland VPA10996/028/ 1.32/2.67 Suspension for - QH02AB02 POM: - Full application - Intramuscular Suspension for Limited 001 milligram(s)/millil injection Prescription Only Dexamethasone (Article 12(3) of use Injection itre Medicine as sodium Directive No defined in phosphate 2001/82/EC) relevant national - legislation Dexamethasone phenylpropionate

Dexa-ject 2 Dopharma VPA10791/004/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular mg/ml solution Research B.V. 001 milligram(s)/millil injection Prescription Only Dexamethasone application use for injection for itre Medicine as sodium (Article 13(1) of - Intramuscular cattle, horses, defined in phosphate Directive No use pigs, dogs and relevant national 2001/82/EC) - Intravenous cats legislation use

Dexameth Chem-Pharm VPA10823/013/ 2
Solution for - QH02AB02 POM: - Informed - Intramuscular 2mg/ml solution 001 milligram(s)/millil injection Prescription Only Dexamethasone consent use for injection itre Medicine as sodium application - Intravenous defined in phosphate (Article 13c of use relevant national Directive No legislation 2001/82/EC)

Dexamethasone Alfasan VPA10980/002/ 2 Solution for - QH02AB02 POM: - ZZZ Informed - Intramuscular 2 mg/ml solution Nederland B.V 001 milligram(s)/millil injection Prescription Only Dexamethasone consent use for injection for itre Medicine as sodium (abridged - Intravenous dogs, cats, cattle defined in phosphate application) - use and horses relevant national Council Directive legislation 81/851/EEC

DEXASHOT 2 Vet-Agro Multi- VPA20742/003/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular mg/ml solution Trade Company 001 milligram(s)/millil injection Prescription Only Dexamethasone application use for injection for Sp z o.o. itre Medicine as (Article 13(1) of - Intramuscular cattle, horses, defined in Directive No use pigs, dogs and relevant national 2001/82/EC) - Intravenous cats legislation use

Veterinary Medicines Authorised/Transfer Pending Products Page 56 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Dexatat 2 mg/ml aniMedica VPA10826/002/ 2 Solution for - QH02AB02 POM: - Well-established - Intramuscular solution for GmbH 001 milligram(s)/millil injection Prescription Only Dexamethasone use application use Injection itre Medicine as sodium (Article 13a of - Intravenous defined in phosphate Directive No use relevant national 2001/82/EC) legislation

DEXMOPET 0.5 Vetpharma VPA10516/013/ 0.5 Solution for - QN05CM18 VPO: Veterinary - Generic - Intramuscular mg/ml solution Animal Health, 001 milligram(s)/millil injection Practitioner Only Dexmedetomidi application use for injection for S.L. itre as defined in ne (Article 13(1) of - Intravenous dogs and cats relevant national Directive No use legislation 2001/82/EC)

Dexrapid 2 Richter Pharma VPA10801/016/ 2.0 Solution for - QH02AB02 POM: - Generic - Intraarticular mg/ml solution AG 001 milligram(s)/millil injection Prescription Only Dexamethasone application use for injection itre Medicine as (as (Article 13(1) of - Intramuscular defined in dexamethasone Directive No use relevant national sodium 2001/82/EC) - Intravenous legislation phosphate) use

DFV DOXIVET Divasa-Farmavic VPA10505/001/ 200 Solution for use - QJ01AA02 POM: - Doxycycline Hybrid - Oral use 200 mg/ml, S.A. 001 milligram(s)/millil in drinking water Prescription Only hyclate application solution for use itre Medicine as (Article 13(3) of in drinking water defined in Directive No for pigs and relevant national 2001/82/EC) chickens legislation

DFV DOXIVET Divasa-Farmavic VPA10505/002/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Generic - In drinking 500 mg/g, S.A. 001 milligram(s)/gra in drinking water Prescription Only hyclate application water use powder for use in m Medicine as (Article 13(1) of drinking water for defined in Directive No pigs and relevant national 2001/82/EC) chickens legislation

Diatrim 200 Eurovet Animal VPA10989/070/ 200, 40 Solution for - QJ01EW10 POM: - Sulfadiazine Generic - Intramuscular mg/ml + 40 Health B.V. 001 milligram(s)/millil injection Prescription Only - Trimethoprim application use mg/ml solution itre Medicine as (Article 13(1) of - Intravenous for injection defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Diazedor 5 Richter Pharma VPA10801/011/ 5 Solution for - QN05BA01 VPO: Veterinary - Diazepam ph. Generic - Intravenous mg/ml solution AG 001 milligram(s)/millil injection Practitioner Only eur. application use for injection for itre as defined in (Article 13(1) of dogs and cats relevant national Directive No legislation 2001/82/EC)

DIB 1.0 g Syn Vet-Pharma VPA23174/003/ 1.0 gram(s) Vaginal delivery - QG03DA04 VPO: Veterinary - Progesterone Well-established - Vaginal use Vaginal Delivery Ireland Limited 001 system Practitioner Only use application System for Cattl as defined in (Article 13a of relevant national Directive No legislation 2001/82/EC)

Dihydrostreptom Alfasan VPA10980/004/ 25 percent Solution for - QJ01GA90 POM: - ZZZ Informed - Intramuscular ycin 25% Nederland B.V 001 weight/volume injection Prescription Only Dihydrostreptom consent use Solution for Medicine as ycin sulphate (abridged Injection defined in application) - relevant national Council Directive legislation 81/851/EEC

Dilaterol 25 Le Vet Beheer VPA10475/002/ 25 Oral gel - QR03CC13 POM: - Clenbuterol Generic - Oral use micrograms/ml B.V. 001 microgram(s)/mil Prescription Only hydrochloride application syrup for horses lilitre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 57 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration DILUMAREX Boehringer VPA10454/031/ . Solution for - QV07AB POM: Full application - Intramuscular Ingelheim 001 injection Prescription Only (Article 12(3) of use Vetmedica Medicine as Directive No - Subcutaneous GmbH defined in 2001/82/EC) use relevant national legislation

Dimazon 50 Intervet Ireland VPA10996/109/ 50 Solution for - QC03CA01 POM: - Furosemide Full application - Intramuscular mg/ml Solution Limited 001 milligram(s)/millil injection Prescription Only Monoethanolam (Article 12(3) of use for Injection itre Medicine as ine Directive No - Intravenous defined in 2001/82/EC) use relevant national legislation

DINALGEN 300 Ecuphar VPA10389/001/ 300 Oral solution - QM01AE03 POM: - Ketoprofen Well-established - Oral use mg/ml oral Veterinaria 001 milligram(s)/millil Prescription Only use application solution for use S.L.U. itre Medicine as (Article 13a of in drinking water defined in Directive No for cattle and relevant national 2001/82/EC) pigs legislation

DINALGEN 150 Ecuphar VPA10389/002/ 150 Solution for - QM01AE03 POM: - Ketoprofen Well-established - Intramuscular mg/ml solution Veterinaria 001 milligram(s)/millil injection Prescription Only use application use for injection for S.L.U. itre Medicine as (Article 13a of - Intravenous cattle, pigs and defined in Directive No use horses relevant national 2001/82/EC) legislation

Dipen 100ml Bimeda Animal VPA22033/009/ 200, 200 Suspension for - QJ01RA01 POM: - Procaine Informed - Intramuscular Suspension for Health Limited 001 milligram(s)/millil injection Prescription Only benzylpenicillin consent use Injection for itre Medicine as - application cattle, sheep and defined in Dihydrostreptom (Article 13c of pigs relevant national ycin sulfate Directive No legislation 2001/82/EC)

Distocur 34 Dopharma VPA10791/013/ 34 Oral suspension - QP52AG06 POM: - Oxyclozanide Generic - Oral use mg/ml Oral Research B.V. 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(1) of cattle and sheep defined in Directive No relevant national 2001/82/EC) legislation

Diurizone Vetoquinol VPA10983/011/ 50, 0.5 Solution for - QC03AX01 POM: - Full application - Intramuscular Injectable Ireland Limited 001 milligram(s)/millil injection Prescription Only Hydrochlorothia (Article 12(3) of use itre Medicine as zide Directive No - Intravenous defined in - 2001/82/EC) use relevant national Dexamethasone - Subcutaneous legislation use

Diurizone Vetoquinol VPA10983/010/ 0.25, 75.0 Oral powder - QC03AX01 POM: - Full application - Oral use Powder Ireland Limited 001 milligram(s)/gra Prescription Only Dexamethasone (Article 12(3) of m Medicine as - Directive No defined in Hydrochlorothia 2001/82/EC) relevant national zide legislation

Dolethal 200 Vetoquinol VPA10983/015/ 200 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital - Intracardiac mg/ml Solution Ireland Limited 001 milligram(s)/millil injection Practitioner Only sodium use for Injection for itre as defined in - Intravenous dogs and cats relevant national use legislation

Dolocarp flavour, aniMedica VPA10826/014/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use 100 mg, GmbH 003 Prescription Only application chewable tablet Medicine as (Article 13(1) of for dogs defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 58 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Dolocarp flavour, aniMedica VPA10826/014/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use 20 mg, chewable GmbH 001 Prescription Only application tablets for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Dolocarp flavour, aniMedica VPA10826/014/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use 50 mg, chewable GmbH 002 Prescription Only application tablet for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Dolorex 10 Intervet Ireland VPA10996/185/ 10 Solution for - QN02AF01 POM: - Butorphanol Well-established - Intramuscular mg/ml Solution Limited 001 milligram(s)/millil injection Prescription Only tartrate use application use for Injection for itre Medicine as (Article 13a of - Intravenous horse, dog and defined in Directive No use cat relevant national 2001/82/EC) - Subcutaneous legislation use

Domidine 10 Eurovet Animal VPA10989/053/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomindine Generic - Intramuscular mg/ml solution Health B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection, for itre as defined in (Article 13(1) of - Intravenous horses and cattl relevant national Directive No use legislation 2001/82/EC)

Domitor 1 mg/ml Orion VPA10664/005/ 1 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Full application - Intramuscular solution for Corporation 001 milligram(s)/millil injection Practitioner Only hydrochloride (Article 12(3) of use injection itre as defined in Directive No - Intravenous relevant national 2001/82/EC) use legislation

Domosedan 10 Orion VPA10664/004/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomidine Full application - Intramuscular mg/ml solution Corporation 001 milligram(s)/millil injection Practitioner Only hydrochloride (Article 12(3) of use for injection itre as defined in Directive No - Intravenous relevant national 2001/82/EC) use legislation

DOMOSEDAN Orion VPA10664/001/ 7.6 Oromucosal gel - QN05CM90 VPO: Veterinary - Detomidine Full application - Sublingual use GEL 7.6 mg/ml Corporation 001 milligram(s)/millil Practitioner Only hydrochloride (Article 12(3) of oromucosal gel itre as defined in Directive No relevant national 2001/82/EC) legislation

DOPHEXINE 20 Dopharma VPA10791/011/ 20 Powder for use - QR05CB02 POM: - Bromhexine Hybrid - In drinking mg/g powder for Research B.V. 001 milligram(s)/gra in drinking Prescription Only application water/milk use use in drinking m water/milk Medicine as (Article 13(3) of water/milk defined in Directive No relevant national 2001/82/EC) legislation

DORAFLOX 100 Dopharma VPA10791/009/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml solution Research B.V. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Doramax 5 Chanelle VPA10987/166/ 5 Pour-on solution - QP54AA03 POM: - Doramectin Generic - Pour-on use mg/ml Pour-on Pharmaceuticals 001 milligram(s)/millil Prescription Only application Solution for Manufacturing itre Medicine as (Article 13(1) of Cattle Limited defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 59 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration DORAXX 100 Dopharma VPA10791/014/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular mg/ml solution Research B.V. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle, pigs and defined in Directive No use sheep relevant national 2001/82/EC) legislation

Dorbene vet 1 Laboratorios VPA10495/002/ 1 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Generic - Intramuscular mg/ml solution SYVA, S.A.U 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for 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

Doxatib 500 Krka, d.d., Novo VPA10774/046/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Generic - Oral use mg/g powder for mesto 001 milligram(s)/gra in drinking water Prescription Only hyclate application use in drinking m Medicine as (Article 13(1) of water for pigs defined in Directive No and chickens relevant national 2001/82/EC) legislation

Doxipulvis 500 SP Veterinaria, VPA10790/008/ 500 Oral powder - QJ01AA02 POM: - Doxycycline Hybrid - Oral use mg/g powder for S.A. 001 milligram(s)/gra Prescription Only application use in drinking m Medicine as (Article 13(3) of water / milk defined in Directive No replacer relevant national 2001/82/EC) legislation

Doxivex, 100 SP Veterinaria, VPA10790/001/ 100 Oral solution - QJ01AA02 POM: - Doxycycline Generic - Oral use mg/ml S.A. 001 milligram(s)/millil Prescription Only hyclate application concentrate for itre Medicine as (Article 13(1) of oral solution for defined in Directive No chickens and relevant national 2001/82/EC) pigs legislation

Doxx-Sol 500 Huvepharma NV VPA10782/017/ 500 Powder for oral - QJ01AA02 POM: - Doxycycline Generic - Oral use mg/g powder for 001 milligram(s)/gra solution Prescription Only hyclate application use in drinking m Medicine as (Article 13(1) of water/milk defined in Directive No replacer for pre- relevant national 2001/82/EC) ruminant calves, legislation pigs and chickens

Doxybactin 200 Le Vet Beheer VPA10475/031/ 200 mg/tablet Tablet - QJ01AA02 POM: - Doxycyline Hybrid - Oral use mg tablets for B.V. 003 Prescription Only application dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Doxybactin 400 Le Vet Beheer VPA10475/031/ 400 mg/tablet Tablet - QJ01AA02 POM: - Doxycyline Hybrid - Oral use mg tablets for B.V. 004 Prescription Only application dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Doxybactin 50 Le Vet Beheer VPA10475/031/ 50 mg/tablet Tablet - QJ01AA02 POM: - Doxycyline Hybrid - Oral use mg tablets for B.V. 002 Prescription Only application dogs and cats Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Doxycare Ecuphar NV VPA10491/013/ 200 mg/tablet Tablet - QJ01AA02 POM: - Doxycycline Hybrid - Per Oral Flavour 200 mg 002 Prescription Only hyclate application Tablets for Cats Medicine as (Article 13(3) of and Dogs defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 60 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Doxycare Ecuphar NV VPA10491/013/ 40 mg/tablet Tablet - QJ01AA02 POM: - Doxycycline Hybrid - Per Oral Flavour 40 mg 001 Prescription Only hyclate application Tablets for Cats Medicine as (Article 13(3) of and Dogs defined in Directive No relevant national 2001/82/EC) legislation

Doxylin, 433 Dopharma VPA10791/007/ 433 Powder for use - QJ01AA02 POM: - Doxycycline Hybrid - In drinking mg/g, powder for Research B.V. 001 milligram(s)/gra in drinking water Prescription Only application water use use in drinking m Medicine as (Article 13(3) of water for defined in Directive No chickens and relevant national 2001/82/EC) turkeys legislation

Doxytab vet. 15 CP-Pharma VPA10810/020/ 15 milligram(s) Tablet - QJ01AA02 POM: - Doxycycline Generic - Oral use mg Tablets for Handelsgesellsc 001 Prescription Only application dogs and cats haft mbH Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Doxytab vet. 200 CP-Pharma VPA10810/020/ 200 milligram(s) Tablet - QJ01AA02 POM: - Doxycycline Hybrid - Oral use mg Tablets for Handelsgesellsc 003 Prescription Only application dogs haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Doxytab vet. 400 CP-Pharma VPA10810/020/ 400 milligram(s) Tablet - QJ01AA02 POM: - Doxycycline Hybrid - Oral use mg Tablets for Handelsgesellsc 004 Prescription Only application dogs haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Doxytab vet. 50 CP-Pharma VPA10810/020/ 50 milligram(s) Tablet - QJ01AA02 POM: - Doxycycline Hybrid - Oral use mg Tablets for Handelsgesellsc 002 Prescription Only application dogs and cats haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Dozuril 25 mg/ml Dopharma VPA10791/002/ 25 Solution for use - QP51AJ01 POM: - Toltrazuril Generic - Oral use solution for use Research B.V. 001 milligram(s)/millil in drinking water Prescription Only application in drinking water itre Medicine as (Article 13(1) of for chickens defined in Directive No relevant national 2001/82/EC) legislation

Draxxin Plus 100 Zoetis Belgium VPA10387/099/ 100, 120 Solution for - QJ01FA POM: - Tulathromycin Fixed - Subcutaneous mg/ml + 120 S.A. 001 milligram(s)/millil injection Prescription Only - Ketoprofen combination use mg/ml solution itre Medicine as application for injection for defined in (Article 13b of cattle relevant national Directive No legislation 2001/82/EC)

Droncit Tablets Vetoquinol SA VPA10521/005/ 50.0 mg/tablet Tablet - QP52AA01 CAM: - Praziquantel - Oral use 50 mg 001 Companion Animal Medicine as defined in relevant national legislation

Drontal Cat Vetoquinol SA VPA10521/007/ 20/230 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel - Oral use Tablets 001 Companion - Pyrantel Animal Medicine embonate as defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 61 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Drontal Cat XL Vetoquinol SA VPA10521/007/ 30,345 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel Full application - Oral use Film-coated 002 Companion - Pyrantel (Article 12(3) of Tablets Animal Medicine embonate Directive No as defined in 2001/82/EC) relevant national legislation

Drontal Dog Vetoquinol SA VPA10521/012/ 150,144,50 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use Tasty Bone 001 mg/tablet Companion - Praziquantel application 150/144/50 mg Animal Medicine - Pyrantel (Article 13(1) of tablets as defined in embonate Directive No relevant national 2001/82/EC) legislation

Drontal Dog Vetoquinol SA VPA10521/012/ 525,504,175 Tablet - QP52AA51 CAM: - Febantel Generic - Oral use Tasty Bone XL 002 mg/tablet Companion - Pyrantel application 525/504/175 mg Animal Medicine embonate (Article 13(1) of tablets as defined in - Praziquantel Directive No relevant national 2001/82/EC) legislation

Drontal Oral Vetoquinol SA VPA10521/008/ 15 / 5 Oral suspension - QP52AF02 CAM: - Febantel Full application - Oral use Suspension for 001 milligram(s)/millil Companion - Pyrantel (Article 12(3) of Puppies itre Animal Medicine embonate Directive No as defined in 2001/82/EC) relevant national legislation

Drontal Plus Vetoquinol SA VPA10521/006/ 144, 50, 150 Tablet - QP52AC55 CAM: - Praziquantel Fixed - Oral use Flavour Bone 003 mg/tablet Companion - Febantel combination Shaped Tablets Animal Medicine - Pyrantel application as defined in embonate (Article 13b of relevant national Directive No legislation 2001/82/EC)

Drontal Plus Vetoquinol SA VPA10521/011/ 150, 144, 50 Tablet - QP52AF30 CAM: - Febantel Informed - Oral use Flavour Tablets 001 mg/tablet Companion - Praziquantel consent for Dogs Animal Medicine - Pyrantel application as defined in embonate (Article 13c of relevant national Directive No legislation 2001/82/EC)

Drontal Plus Vetoquinol SA VPA10521/006/ 150, 144, 50 Tablet - QP52AA51 CAM: - Febantel - Oral use Tablets 001 mg/tablet Companion - Praziquantel Animal Medicine - Pyrantel as defined in embonate relevant national legislation

Drontal Plus XL Vetoquinol SA VPA10521/009/ 175, 504, 525 Tablet - QP52AF30 CAM: - Praziquantel Informed - Oral use Flavour Tablets 001 mg/tablet Companion - Febantel consent for Dogs Animal Medicine - Pyrantel application as defined in embonate (Article 13c of relevant national Directive No legislation 2001/82/EC)

Drontal Plus XL Vetoquinol SA VPA10521/006/ 175, 504, 525 Tablet - QP52AC55 CAM: - Praziquantel - Oral use Tablets 002 mg/tablet Companion - Febantel Animal Medicine - Pyrantel as defined in embonate relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 62 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Drontal Tasty Vetoquinol SA VPA10521/014/ 150,144,50 Tablet - QP52AC55 POM: - Febantel Generic - Oral use Bone Multi-worm 001 mg/tablet Prescription Only - Praziquantel application 150/144/50 mg Medicine as - Pyrantel (Article 13(1) of tablets defined in embonate Directive No relevant national 2001/82/EC) legislation

Drontal Tasty Vetoquinol SA VPA10521/014/ 525,504,175 Tablet - QP52AA51 POM: - Febantel Generic - Oral use Bone Multi-worm 002 mg/tablet Prescription Only - Praziquantel application XL 525/504/175 Medicine as - Pyrantel (Article 13(1) of mg tablets defined in embonate Directive No relevant national 2001/82/EC) legislation

Drontal Tasty Vetoquinol SA VPA10521/015/ 150,144,50 Tablet - QP52AC55 POM: - Febantel Generic - Oral use Bone Wormer 001 mg/tablet Prescription Only - Praziquantel application 150/144/50 mg Medicine as - Pyrantel (Article 13(1) of tablets defined in embonate Directive No relevant national 2001/82/EC) legislation

Drontal Tasty Vetoquinol SA VPA10521/015/ 525,504,175 Tablet - QP52AA51 POM: - Febantel Generic - Oral use Bone Wormer XL 002 mg/tablet Prescription Only - Praziquantel application 525/504/175 mg Medicine as - Pyrantel (Article 13(1) of tablets defined in embonate Directive No relevant national 2001/82/EC) legislation

Dugmectin 18.7 ECO Animal VPA22693/010/ 18.7 Oral paste - QP54AA01 POM: - Ivermectin Informed - Oral use mg/g Oral Paste Health Europe 001 milligram(s)/gra Prescription Only consent for Horses Limited m Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Dugnixon 50 GLOBAL VET VPA10477/004/ 50 Solution for - QM01AG90 POM: - Flunixin Generic - Intramuscular mg/ml solution HEALTH SL 001 milligram(s)/millil injection Prescription Only meglumine application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, pigs and defined in Directive No use horses relevant national 2001/82/EC) legislation

Duocycline 10% Univet Limited VPA10990/009/ 10 percent Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular Solution for 001 weight/volume injection Prescription Only hydrochloride use Injection Medicine as defined in relevant national legislation

Duocycline LA Univet Limited VPA10990/016/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline ZZZ Informed - Intramuscular 200 mg/ml 001 milligram(s)/millil injection Prescription Only dihydrate consent use Solution for itre Medicine as (abridged Injection defined in application) - relevant national Council Directive legislation 81/851/EEC

Duodip 3.1 %w/v Bimeda Animal VPA22033/011/ 3.1 percent Teat dip - QD08A LM: Licensed - Ammonium Informed - Topical use Concentrated Health Limited 001 weight/volume Merchant as lauryl sulphate consent Teat Dip defined in (as a application relevant national concentrate 27- (Article 13c of legislation 28% w/w) Directive No 2001/82/EC) Duofast Norbrook VPA22664/003/ 40, 200 Intramammary - QJ51 POM: - Trimethoprim Informed - Intramammary Intramammary Laboratories 001 milligram(s)/millil suspension Prescription Only - Sulphadiazine consent use Suspension (Ireland) Limited itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Duotech Oral Norbrook VPA22664/057/ 25, 50 Oral suspension - QP52AC30 POM: - Oxfendazole ZZZ Informed - Oral use Suspension for Laboratories 001 milligram(s)/millil Prescription Only - Closantel consent Sheep (Ireland) Limited itre Medicine as sodium dihydrate (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

Veterinary Medicines Authorised/Transfer Pending Products Page 63 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Duowin, Virbac S.A. VPA10988/054/ 1.88 / 0.2 Cutaneous - QP53AC POM: - Permethrin - Topical use Cutaneous 001 grams/100 spray, solution Prescription Only (40/60) spray, Solution millilitres Medicine as - Pyriproxyfen defined in relevant national legislation

Duphalyte Zoetis Belgium VPA10387/023/ . Solution for - QB05BB POM: - Monosodium Full application - Intraperitoneal Solution for S.A. 001 injection Prescription Only glutamate (Article 12(3) of use Injection Medicine as monohydrate Directive No - Intravenous defined in - dl-Valine 2001/82/EC) use relevant national - dl-Tryptophane - Subcutaneous legislation - Threonine use - dl- Phenylalanine - Methionine - Lysine Hydrochloride - Leucine - Isoleucine - Histidine hydrochloride monohydrate - Cysteine hydrochloride monohydrate - Arginine hydrochloride - Glucose anhydrous - Dexpanthenol - Nicotinamide - Cyanocobalamin - Pyridoxine Hydrochloride - Riboflavine sodium phosphate - Thiamine hydrochloride - Potassium chloride - Magnesium sulphate heptahydrate - Calcium chloride hexahydrate

Dycoxan 2.5 Chanelle VPA10987/122/ 2.5 Oral suspension - QP51AJ03 POM: - Diclazuril Generic - Oral use mg/ml Oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application Suspension for Manufacturing itre Medicine as (Article 13(1) of sheep and cattle Limited defined in Directive No relevant national 2001/82/EC) legislation

Ecofleece 10% Bimeda Animal VPA22033/012/ 10 percent Concentrate for - QP53AC POM: - Cypermethrin Informed - Topical use w/w Sheep Dip Health Limited 001 weight/weight dip suspension Prescription Only high cis consent Concentrate Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Ecomectin 10 ECO Animal VPA22693/001/ 10 Solution for - QP54AA01 POM: - Ivermectin Well-established - Subcutaneous mg/ml Solution Health Europe 001 milligram(s)/millil injection Prescription Only use application use for Injection Limited itre Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 64 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Ecomectin 18.7 ECO Animal VPA22693/009/ 18.7 Oral paste - QP54AA01 POM: - Ivermectin Informed - Oral use mg/g Oral Paste Health Europe 001 milligram(s)/gra Prescription Only consent for Horses Limited m Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Ecomectin 5 ECO Animal VPA22693/003/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin Well-established - Topical use mg/ml Pour-on Health Europe 001 milligram(s)/millil Prescription Only use application Solution for Limited itre Medicine as (Article 13a of Cattle defined in Directive No relevant national 2001/82/EC) legislation

Ecomectin 6 ECO Animal VPA22693/013/ 6 Oral powder - QP54AA01 POM: - Ivermectin Generic - Oral use mg/g Oral Health Europe 001 milligram(s)/gra Prescription Only application Powder for pigs Limited m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Ecomectin 6 ECO Animal VPA22693/011/ 6 Premix for - QP54AA01 POM: - Ivermectin Generic - Oral use mg/g Premix for Health Europe 001 milligram(s)/gra medicated Prescription Only application medicated Limited m feeding stuff Medicine as (Article 13(1) of feeding stuff for defined in Directive No pigs relevant national 2001/82/EC) legislation

Ectoflits Summer Bimeda Animal VPA22033/013/ 60 percent Concentrate for - QP53AF POM: - Dimpylate Informed - Topical use and Winter Health Limited 001 weight/weight dip solution Prescription Only (Diazinon consent Sheep Dip, 60 Medicine as Stabilised application %w/w defined in Technical) (Article 13c of Concentrate for relevant national Directive No Dip Solution legislation 2001/82/EC)

Ectofly 12.5 Bimeda Animal VPA22033/059/ 12.5 Pour-on solution - QP53AC08 POM: - Cypermethrin Generic - Topical use mg/ml Pour-On Health Limited 001 milligram(s)/millil Prescription Only high:cis (80:20) application Solution for itre Medicine as (Article 13(1) of Sheep defined in Directive No relevant national 2001/82/EC) legislation

Ectospec 2.5% Bimeda Animal VPA22033/014/ 2.5 percent Pour-on solution - QP53AC POM: - Cypermethrin Informed - Topical use w/v Pour-On Health Limited 001 weight/volume Prescription Only technical (93%) consent Solution Medicine as (cis: trans 50:50) application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Efex 10 mg Ceva Santé VPA10815/036/ 10 mg/tablet Chewable tablet - QJ01MA93 POM: - Marbofloxacin Hybrid - Oral use chewable tablets Animale 001 Prescription Only application for cats and dog Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Efex 100 mg Ceva Santé VPA10815/036/ 100 mg/tablet Chewable tablet - QJ01MA93 POM: - Marbofloxacin Hybrid - Oral use chewable tablets Animale 003 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Efex 40 mg Ceva Santé VPA10815/036/ 40 mg/tablet Chewable tablet - QJ01MA93 POM: - Marbofloxacin Hybrid - Oral use chewable tablets Animale 002 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 65 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration EFFIPRO 134 Virbac S.A. VPA10988/076/ 134 mg/pipette Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Topical use mg spot-on 002 solution Prescription Only application solution for Medicine as (Article 13(3) of medium dogs defined in Directive No relevant national 2001/82/EC) legislation

EFFIPRO 2.5 Virbac S.A. VPA10988/072/ 2.5 Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Cutaneous use mg/ml cutaneous 001 milligram(s)/millil spray, solution Prescription Only application spray, solution itre Medicine as (Article 13(3) of for cats and dog defined in Directive No relevant national 2001/82/EC) legislation

EFFIPRO 268 Virbac S.A. VPA10988/076/ 268 mg/pipette Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Topical use mg spot-on 003 solution Prescription Only application solution for large Medicine as (Article 13(3) of dogs defined in Directive No relevant national 2001/82/EC) legislation

EFFIPRO 402 Virbac S.A. VPA10988/076/ 402 mg/pipette Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Topical use mg spot-on 004 solution Prescription Only application solution for very Medicine as (Article 13(3) of large dogs defined in Directive No relevant national 2001/82/EC) legislation

EFFIPRO 50 mg Virbac S.A. VPA10988/075/ 50 mg/pipette Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Cutaneous use spot-on solution 001 solution Prescription Only application for cats Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

EFFIPRO 67 mg Virbac S.A. VPA10988/076/ 67 mg/pipette Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Topical use spot-on solution 001 solution Prescription Only application for small dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Effipro duo 100 Virbac S.A. VPA10988/100/ 100, 120 Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use mg / 120 mg 006 mg/pipette Prescription Only - Pyriproxyfen combination spot-on solution Medicine as application for very large defined in (Article 13b of cats relevant national Directive No legislation 2001/82/EC)

Effipro duo 134 Virbac S.A. VPA10988/100/ 134,40 Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use mg / 40 mg spot- 002 mg/pipette Prescription Only - Pyriproxyfen combination on solution for Medicine as application medium dogs defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Effipro duo 268 Virbac S.A. VPA10988/100/ 268,80 Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use mg / 80 mg spot- 003 mg/pipette Prescription Only - Pyriproxyfen combination on solution for Medicine as application large dogs defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Effipro duo 402 Virbac S.A. VPA10988/100/ 402,120 Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use mg / 120 mg 004 mg/pipette Prescription Only - Pyriproxyfen combination spot-on solution Medicine as application for very large defined in (Article 13b of dogs relevant national Directive No legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 66 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Effipro duo 50 Virbac S.A. VPA10988/100/ 50,60 mg/pipette Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use mg / 60 mg spot- 005 Prescription Only - Pyriproxyfen combination on solution for Medicine as application cats defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Effipro duo 67 Virbac S.A. VPA10988/100/ 67, 20 Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use mg / 20 mg spot- 001 mg/pipette Prescription Only - Pyriproxyfen combination on solution for Medicine as application small dogs defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Effitix 134 Virbac S.A. VPA10988/097/ 134, 1200 Spot-on solution - QP53AC54 POM: - Fipronil Fixed - Cutaneous use mg/1200 mg 003 mg/pipette Prescription Only - Permethrin combination spot-on solution Medicine as application for medium dogs defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Effitix 26.8 Virbac S.A. VPA10988/097/ 26.8, 240 Spot-on solution - QP53AC54 POM: - Fipronil Fixed - Cutaneous use mg/240 mg spot- 001 mg/pipette Prescription Only - Permethrin combination on solution for Medicine as application very small dogs defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Effitix 268 Virbac S.A. VPA10988/097/ 268, 2400 Spot-on solution - QP53AC54 POM: - Fipronil Fixed - Cutaneous use mg/2400 mg 004 mg/pipette Prescription Only - Permethrin combination spot-on solution Medicine as application for large dogs defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Effitix 402 Virbac S.A. VPA10988/097/ 402, 3600 Spot-on solution - QP53AC54 POM: - Fipronil Fixed - Cutaneous use mg/3600 mg 005 mg/pipette Prescription Only - Permethrin combination spot-on solution Medicine as application for very large defined in (Article 13b of dogs relevant national Directive No legislation 2001/82/EC)

Effitix 67 mg/600 Virbac S.A. VPA10988/097/ 67, 600 Spot-on solution - QP53AC54 POM: - Fipronil Fixed - Cutaneous use mg spot-on 002 mg/pipette Prescription Only - Permethrin combination solution for small Medicine as application dogs defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Effydral Tablets Zoetis Belgium VPA10387/024/ . gram/tablet Effervescent - QB05XA LM: Licensed - Anhydrous ZZZ --Unknown- - Oral use S.A. 001 tablet Merchant as citric acid defined in - Potassium relevant national chloride legislation - Sodium chloride - Sodium hydrogen carbonate - Glycine - Lactose monohydrate EFICUR 50 Laboratorios VPA10846/006/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular mg/ml Hipra S.A. 001 milligram(s)/millil injection Prescription Only Hydrochloride application use suspension for itre Medicine as (Article 13(1) of - Subcutaneous injection for pigs defined in Directive No use and cattle relevant national 2001/82/EC) legislation

Eirpet Flea and P.B.S Sales VPA10878/001/ 15 percent Collar - QP53AF CAM: - Dimpylate Informed - Topical use Tick Collar for Limited 001 weight/volume Companion consent Dogs Animal Medicine application as defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 67 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration EKYFLOGYL AUDEVARD VPA10481/002/ 1.80/8.65 Gel - QM02AX POM: - Prednisolone Generic - Cutaneous use 1.8mg/ml + 001 milligram(s)/millil Prescription Only - Lidocaine application 8.7mg/ml GEL itre Medicine as (Article 13(1) of FOR HORSES defined in Directive No relevant national 2001/82/EC) legislation

Elivec 5 mg/ml LIVISTO Int'l, VPA10425/005/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Generic - Pour-on use pour-on solution S.L. 001 milligram(s)/millil Prescription Only application for cattle itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Embotape Oral Bimeda Animal VPA22033/015/ 400 Oral paste - QP52AF02 POM: - Pyrantel ZZZ Informed - Oral use Paste 400 mg/g Health Limited 001 milligram(s)/gra Prescription Only embonate consent m Medicine as (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

Emdofluxin 50 Emdoka bvba VPA10534/008/ 50 Solution for - QM01AG90 POM: - Flunixin Generic - Intramuscular mg/ml solution 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, pigs and defined in Directive No use horses relevant national 2001/82/EC) legislation

Emeprid 1 mg/ml Ceva Santé VPA10815/017/ 1 Oral solution - QA03FA01 POM: - Generic - Oral use oral solution for Animale 001 milligram(s)/millil Prescription Only Metoclopramide application dogs and cats itre Medicine as hydrochloride (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Emeprid 5 mg/ml Ceva Santé VPA10815/018/ 5 Solution for - QA03FA01 POM: - Generic - Intramuscular solution for Animale 001 milligram(s)/millil injection Prescription Only Metoclopramide application use injection for dogs itre Medicine as hydrochloride (Article 13(1) of - Intravenous and cats defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Endex 19.5 % Elanco GmbH VPA22020/035/ 19.5 percent Oral suspension - QP52AC30 POM: - Triclabendazole - Oral use w/v Oral 001 weight/volume Prescription Only - Levamisole Suspension for Medicine as hydrochloride Cattle defined in relevant national legislation

Endex 8.75 % Elanco GmbH VPA22020/036/ 8.75 percent Oral suspension - QP52AC30 POM: - Triclabendazole - Oral use w/v Oral 001 weight/volume Prescription Only - Levamisole Suspension for Medicine as hydrochloride Sheep defined in relevant national legislation

Endofluke 100 Bimeda Animal VPA22033/060/ 100 Oral suspension - QP52AC01 POM: - Triclabendazole Generic - Oral use mg/ml Oral Health Limited 001 milligram(s)/millil Prescription Only application Suspension itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Endogard Plus Krka, d.d., Novo VPA10774/004/ 150, 144, 50 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use Flavour Tablets mesto 001 mg/tablet Companion - Praziquantel application for dogs Animal Medicine - Pyrantel (Article 13(1) of as defined in embonate Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 68 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Endogard Plus Krka, d.d., Novo VPA10774/004/ 525, 504, 175 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use XL Tablets for mesto 002 mg/tablet Companion - Praziquantel application dogs Animal Medicine - Pyrantel (Article 13(1) of as defined in embonate Directive No relevant national 2001/82/EC) legislation

Endospec 10% Bimeda Animal VPA22033/016/ 10 percent Oral suspension - QP52AC11 POM: - Albendazole ZZZ --Unknown- - Oral use SC Health Limited 001 weight/volume Prescription Only Medicine as defined in relevant national legislation

Endospec 2.5% Bimeda Animal VPA22033/017/ 2.5 percent Oral suspension - QP52AC11 POM: - Albendazole ZZZ Informed - Oral use SC Health Limited 001 weight/volume Prescription Only consent Medicine as (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

Engemycin 10 % Intervet Ireland VPA10996/071/ 10 percent Solution for - QJ01AA06 POM: - Oxytetracycline Full application - Intramuscular DD Solution for Limited 001 weight/volume injection Prescription Only hydrochloride (Article 12(3) of use injection Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national - Subcutaneous legislation use

Engemycin Intervet Ireland VPA10996/212/ 25 Cutaneous - QD06AA03 POM: - Oxytetracycline Hybrid - Cutaneous use Spray, 25 Limited 001 milligram(s)/millil spray, Prescription Only hydrochloride application mg/mL, itre suspension Medicine as (Article 13(3) of cutaneous spray, defined in Directive No suspension for relevant national 2001/82/EC) cattle, sheep and legislation pigs

Enovex 0.5 %w/v Norbrook VPA22664/056/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin - Topical use Pour-On Solution Laboratories 001 weight/volume Prescription Only for Cattle (Ireland) Limited Medicine as defined in relevant national legislation

Enovex 1% w/v Norbrook VPA22664/055/ 1.0 percent Solution for - QP54AA01 POM: - Ivermectin Informed - Subcutaneous Solution for Laboratories 001 weight/volume injection Prescription Only consent use Injection for (Ireland) Limited Medicine as application cattle, sheep and defined in (Article 13c of pigs relevant national Directive No legislation 2001/82/EC)

Enrobactin 25 Le Vet Beheer VPA10475/020/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml B.V. 001 milligram(s)/millil Prescription Only application concentrate for itre Medicine as (Article 13(1) of oral solution for defined in Directive No pet rabbits, relevant national 2001/82/EC) rodents, legislation ornamental birds and reptiles

Enrocare 100 Emdoka bvba VPA10534/007/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml Solution 003 milligram(s)/millil injection Prescription Only application use for Injection for itre Medicine as (Article 13(1) of - Intravenous Cattle and Pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Enrocare 25 Ecuphar NV VPA10491/007/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml Oral 004 milligram(s)/millil Prescription Only application Solution for Pet itre Medicine as (Article 13(1) of Rabbits, defined in Directive No Rodents, relevant national 2001/82/EC) Ornamental legislation Birds and Reptiles

Veterinary Medicines Authorised/Transfer Pending Products Page 69 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Enrocare 25 Emdoka bvba VPA10534/007/ 25 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only application use for Injection for itre Medicine as (Article 13(1) of - Subcutaneous Dogs, Cats, defined in Directive No use Rabbits, relevant national 2001/82/EC) Rodents, legislation Reptiles and Ornamental bird

Enrocare 50 Emdoka bvba VPA10534/007/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml Solution 002 milligram(s)/millil injection Prescription Only application use for Injection for itre Medicine as (Article 13(1) of - Intravenous Cattle, Pigs, defined in Directive No use Dogs and Cats relevant national 2001/82/EC) - Subcutaneous legislation use

Enrocat flavour LIVISTO Int'l, VPA10425/010/ 25 Oral suspension - QJ01MA90 POM: - Enrofloxacin Hybrid - Oral use 25 mg/ml oral S.L. 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(3) of cats defined in Directive No relevant national 2001/82/EC) legislation

ENRODEXIL Industrial VPA10509/004/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular 100 mg/ml Veterinaria, S.A. 001 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(1) of - Intravenous injection for defined in Directive No use cattle and pigs relevant national 2001/82/EC) - Subcutaneous legislation use

ENRO-K 100 Laboratorios VPA10786/001/ 100 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml Solution Karizoo S.A. 001 milligram(s)/millil Prescription Only application for use in itre Medicine as (Article 13(1) of drinking water defined in Directive No relevant national 2001/82/EC) legislation

Enrotril Max 100 Norbrook VPA22664/089/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Subcutaneous mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only application use for Injection for (Ireland) Limited itre Medicine as (Article 13(1) of Cattle defined in Directive No relevant national 2001/82/EC) legislation

Enrotron 100 aniMedica VPA10826/026/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml Solution GmbH 003 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Enrotron 100 aniMedica VPA10826/018/ 100 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml solution GmbH 001 milligram(s)/millil Prescription Only application for use in itre Medicine as (Article 13(1) of drinking water for defined in Directive No chicken, turkeys relevant national 2001/82/EC) and rabbits legislation

Enrotron 25 aniMedica VPA10826/026/ 25 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml Solution GmbH 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous dogs, cats, defined in Directive No use rodents, reptiles relevant national 2001/82/EC) and ornamental legislation birds Enrotron 5 mg/ml aniMedica VPA10826/016/ 5 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use oral solution for GmbH 001 milligram(s)/millil Prescription Only application pigs itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 70 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Enrotron 50 aniMedica VPA10826/026/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml Solution GmbH 002 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, pigs, dogs defined in Directive No use and cats relevant national 2001/82/EC) - Subcutaneous legislation use

Enrotron Flavour aniMedica VPA10826/011/ 150 milligram(s) Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use 150 mg Tablets GmbH 002 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Enrotron Flavour aniMedica VPA10826/011/ 50 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use 50 mg Tablets GmbH 001 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Enrox Flavour 15 Krka, d.d., Novo VPA10774/001/ 15 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg Tablets for mesto 001 Prescription Only application dogs and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Enrox Flavour Krka, d.d., Novo VPA10774/001/ 150 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use 150 mg Tablets mesto 003 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Enrox Flavour 50 Krka, d.d., Novo VPA10774/001/ 50 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg Tablets for mesto 002 Prescription Only application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Enroxil 100 Krka, d.d., Novo VPA10774/002/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml solution mesto 003 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

ENROXIL 50 Krka, d.d., Novo VPA10774/002/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml solution mesto 002 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous calves, pigs and defined in Directive No use dogs relevant national 2001/82/EC) - Subcutaneous legislation use

Enroxil Max 100 Krka, d.d., Novo VPA10774/002/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intravenous mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle defined in Directive No use relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 71 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Entericolix, CZ Veterinaria, VPA10784/003/ . Emulsion for - QI09AB08 POM: - E.coli strain p4 Full application - Intramuscular emulsion for S.A. 001 injection Prescription Only (f6 adhesins), (Article 12(3) of use injection for pigs Medicine as inactivated Directive No defined in - E.coli strain p5 2001/82/EC) relevant national (f18 adhesins), legislation 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

Enterisol Ileitis Boehringer VPA10454/005/ . tissue culture Lyophilisate + - QI09AE04 POM: - Attenuated live Full application - Oral use lyophilisate and Ingelheim 001 infective dose solvent for Prescription Only bacteria (Article 12(3) of solvent for oral Vetmedica 50/dose suspension Medicine as lawsonia Directive No suspension for GmbH defined in intracellularis 2001/82/EC) pigs relevant national (ms b3903) legislation

Enteroporc AC IDT Biologika VPA10524/006/ . relative Lyophilisate and - QI09AB12 POM: - Clostridium Full application - Intramuscular Lyophilisate and GmbH 001 unit/millilitre solvent for Prescription Only perfrigens type a (Article 12(3) of use solvent for suspension for Medicine as alfa toxoid Directive No suspension for injection defined in - Clostridium 2001/82/EC) injection for pigs relevant national perfringens legislation typea beta2 toxoid - Clostridium perfringens type c beta1 toxoid

Enzaprost 5 Ceva Santé VPA10815/002/ 5 Solution for - QG02AD01 POM: - Dinoprost Generic - Intramuscular mg/ml Solution Animale 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of cattle and pig defined in Directive No relevant national 2001/82/EC) legislation

Enzaprost Bovis Ceva Santé VPA10815/056/ 12.5 Solution for - QG02AD01 POM: - Dinoprost Generic - Intramuscular 12.5 mg/ml Animale 001 milligram(s)/millil injection Prescription Only Tromethamine application use solution for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle relevant national 2001/82/EC) legislation

Enzovax Intervet Ireland VPA10996/079/ 10^5 - 10^6.9 Lyophilisate for - QI04AE01 POM: - Chlamydophila Full application - Intramuscular Limited 001 inclusion-body suspension for Prescription Only abortus live (Article 12(3) of use forming units injection Medicine as attenuated strain Directive No - Subcutaneous defined in ts 1b 2001/82/EC) use relevant national legislation

Epityl 60mg Chanelle VPA10987/100/ 60 mg/tablet Chewable tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use Flavoured Pharmaceuticals 001 Prescription Only application Tablets for Dogs Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Eprecis 20 Ceva Santé VPA10815/024/ 20 Solution for - QP54AA04 POM: - Eprinomectin Hybrid - Subcutaneous mg/ml solution Animale 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(3) of cattle, sheep and defined in Directive No goats relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 72 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Eprecis 5 mg/ml Ceva Santé VPA10815/025/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Generic - Pour-on use pour-on solution Animale 001 milligram(s)/millil Prescription Only application for cattle, sheep itre Medicine as (Article 13(1) of and goats defined in Directive No relevant national 2001/82/EC) legislation

Eprinex 0.5% Boehringer VPA10454/033/ 0.5 percent Pour-on solution - QP54AA04 POM: - Eprinomectin Full application - Topical use w/v Pour-on Ingelheim 001 weight/volume Prescription Only (Article 12(3) of Solution for Beef Vetmedica Medicine as Directive No and Dairy Cattle GmbH defined in 2001/82/EC) relevant national legislation

Eprinex Multi 5 Boehringer VPA10454/034/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Well-established - Topical use mg/ml pour-on Ingelheim 001 milligram(s)/millil Prescription Only use application solution for Vetmedica itre Medicine as (Article 13a of cattle, sheep and GmbH defined in Directive No goats relevant national 2001/82/EC) legislation

Eprivalan Boehringer VPA10454/035/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Generic - Topical use 5mg/ml pour-on Ingelheim 001 milligram(s)/millil Prescription Only application solution for cattle Vetmedica itre Medicine as (Article 13(1) of GmbH defined in Directive No relevant national 2001/82/EC) legislation

Eprizero 5 mg/ml Norbrook VPA22664/103/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Hybrid - Topical use Pour-On Solution Laboratories 001 milligram(s)/millil Prescription Only application for Beef and (Ireland) Limited itre Medicine as (Article 13(3) of Dairy Cattle defined in Directive No relevant national 2001/82/EC) legislation

Epromec 5 Chanelle VPA10987/107/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Generic - Topical use mg/ml Pour-on Pharmaceuticals 001 milligram(s)/millil Prescription Only application Solution for beef Manufacturing itre Medicine as (Article 13(1) of and dairy cattle Limited defined in Directive No relevant national 2001/82/EC) legislation

EQUEST ORAL Zoetis Belgium VPA10387/025/ 18.92 Oral gel - QP54AB02 POM: - Moxidectin Full application - Oral use GEL, 18.92 S.A. 001 milligram(s)/gra Prescription Only (Article 12(3) of mg/g, oral gel for m Medicine as Directive No horses and defined in 2001/82/EC) ponies relevant national legislation

Equest Pramox Zoetis Belgium VPA10387/026/ 19.5, 121.7 Oral gel - QP54AB52 POM: - Moxidectin Fixed - Oral use 19.5 mg/g + S.A. 001 milligram(s)/gra Prescription Only - Praziquantel combination 121.7 mg/g oral m Medicine as application gel defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Equibactin 250 Le Vet Beheer VPA10475/037/ 250, 50 Oral powder - QJ01EW10 POM: - Sulfadiazine Generic - Oral use mg/g + 50 mg/g B.V. 001 milligram(s)/gra Prescription Only - Trimethoprim application oral powder for m Medicine as (Article 13(1) of horses defined in Directive No relevant national 2001/82/EC) legislation

Equibactin vet. Le Vet BV VPA10816/004/ 66.7, 333.3 Oral paste - QJ01EW10 POM: - Trimethoprim Generic - Oral use (333 mg/g + 67 001 milligram(s)/gra Prescription Only - Sulfadiazine application mg/g) Oral Paste m Medicine as (Article 13(1) of for horses defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 73 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Equimax oral gel Virbac S.A. VPA10988/091/ 18.7, 140.3 Oral gel - QP54AA51 POM: - Ivermectin ZZZ Complete - Oral use for horses 001 milligram(s)/gra Prescription Only - Praziquantel application m Medicine as (stand-alone) - defined in Council Directive relevant national 81/851/EEC legislation

Equimax Tabs Virbac S.A. VPA10988/070/ 150, 20 Chewable tablet - QP54AA51 LM: Licensed - Praziquantel Full application - Oral use 150 mg / 20 mg 001 mg/tablet Merchant as - Ivermectin (Article 12(3) of Chewable tablet defined in Directive No for Horses relevant national 2001/82/EC) legislation

Equinor 370 Norbrook VPA22664/114/ 370 Oral paste - QA02BC01 POM: - Omeprazole Generic - Oral use mg/g Oral Paste Laboratories 001 milligram(s)/gra Prescription Only application for Horses (Ireland) Limited m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Equip Artervac Zoetis Belgium VPA10387/027/ . Emulsion for - QI05AA07 POM: - Equine arteritis Full application - Intramuscular emulsion for S.A. 001 injection Prescription Only virus inactivated, (Article 12(3) of use injection for Medicine as strain bucyrus Directive No horses and defined in 2001/82/EC) ponies relevant national legislation

Equip EHV 1,4 Zoetis Belgium VPA10387/028/ . Suspension for - QI05AA05 POM: - Equine herpes Full application - Intramuscular Suspension for S.A. 001 injection Prescription Only virus 1, strain (Article 12(3) of use injection Medicine as 438/77 Directive No defined in inactivated 2001/82/EC) relevant national - Equine herpes legislation virus 4, strain 405/76 inactivated Equip F Zoetis Belgium VPA10387/029/ . Suspension for - QI05AA01 POM: - Inactivated Full application - Intramuscular S.A. 001 injection Prescription Only equine influenza (Article 12(3) of use Medicine as a newmarket 77 Directive No defined in (H7 N7) 2001/82/EC) relevant national - Inactivated legislation equine influenza a borlonge 91 (H3 N8) - Inactivated equine influenza a Kentucky 98 (H3 N8)

Equip FT Zoetis Belgium VPA10387/030/ . Suspension for - QI05AL01 POM: - Inactivated Full application - Intramuscular S.A. 001 injection Prescription Only equine influenza (Article 12(3) of use Medicine as a newmarket 77 Directive No defined in (H7 N7) 2001/82/EC) relevant national - Inactivated legislation equine influenza a borlonge 91 (H3 N8) - Inactivated equine influenza a Kentucky 98 (H3 N8) - Tetanus toxoid (immunopurified)

Equip Rotavirus Zoetis Belgium VPA10387/031/ . Emulsion for - QI05AA09 POM: - Equine Full application - Intramuscular emulsion for S.A. 001 injection Prescription Only rotavirus H2 (Article 12(3) of use injection for Medicine as strain Directive No horses defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 74 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Equip T Zoetis Belgium VPA10387/032/ . Suspension for - QI05AB03 POM: - Tetanus toxoid Full application - Intramuscular S.A. 001 injection Prescription Only (immunopurified) (Article 12(3) of use Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Equipalazone 1 Dechra VPA22622/007/ 1.0 gram(s) Oral paste - QM01AA01 POM: - - Oral use g Oral Paste Regulatory B.V. 001 Prescription Only Phenylbutazone Medicine as defined in relevant national legislation

Equipalazone 1 Dechra VPA22622/006/ 1.0 gram(s) Oral powder - QM01AA01 POM: - Well-established - Oral use g Oral Powder Regulatory B.V. 001 Prescription Only Phenylbutazone use application Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Equiparin 5,000 aniMedica VPA10826/006/ 5.000 Gel - QM02AC99 POM: - Heparin sodium Generic - Cutaneous use IU/100 g gel for GmbH 001 international Prescription Only - Hydroxyethyl application horses unit(s) Medicine as salicylate (Article 13(1) of defined in - Levomenthol Directive No relevant national 2001/82/EC) legislation

Equiparin 50,000 aniMedica VPA10826/006/ 50,000 IU/100g Gel - QM02AC99 POM: - Heparin sodium Generic - Cutaneous use IU/100 g gel for GmbH 002 Prescription Only - Hydroxyethyl application horses Medicine as Salicylate (Article 13(1) of defined in - Levomenthol Directive No relevant national 2001/82/EC) legislation

Equipred 50 mg CP-Pharma VPA10810/017/ 50 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Hybrid - Oral use tablets for horse Handelsgesellsc 001 Prescription Only application haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

EquiShield EHV Dechra VPA22622/025/ . Emulsion for - QI05AA05 POM: - Inactivated Full application - Intramuscular emulsion for Regulatory B.V. 001 injection Prescription Only equine herpes (Article 12(3) of use injection for Medicine as virus ehv msv Directive No horses defined in bio 82S 2001/82/EC) relevant national legislation

Equizol 400 mg CP-Pharma VPA10810/014/ 400 mg/sachet Gastro-resistant - QA02BC01 POM: - Omeprazole Hybrid - Oral use gastro-resistant Handelsgesellsc 001 granules Prescription Only application granules for haft mbH Medicine as (Article 13(3) of horses defined in Directive No relevant national 2001/82/EC) legislation

EQVALAN DUO, Boehringer VPA10454/036/ 0.12, 0.6 Oral paste - QP54AA51 POM: - Ivermectin Fixed - Oral use oral paste Ingelheim 001 g/syringe Prescription Only - Praziquantel combination Vetmedica Medicine as application GmbH defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

EQVALAN Oral Boehringer VPA10454/037/ 18.7 Oral paste - QP54AA01 POM: - Ivermectin Full application - Oral use Paste for Horses Ingelheim 001 milligram(s)/gra Prescription Only (Article 12(3) of 18.7 mg/g Vetmedica m Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 75 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration ERADIA 125 Virbac S.A. VPA10988/109/ 125 Oral suspension - QP51AA01 POM: - Metronidazole Hybrid - Oral use mg/ml oral 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(3) of dogs defined in Directive No relevant national 2001/82/EC) legislation

ERAQUELL 18.7 Virbac S.A. VPA10988/104/ 18.7 Oral paste - QP54AA01 POM: - Ivermectin Generic - Oral use mg/g Oral Paste 001 milligram(s)/gra Prescription Only application m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Eraquell Tabs, Virbac S.A. VPA10988/077/ 20 mg/tablet Chewable tablet - QP54AA01 LM: Licensed - Ivermectin Full application - Oral use 20 mg Chewable 001 Merchant as (Article 12(3) of tablets for defined in Directive No Horses relevant national 2001/82/EC) legislation

Erythrocin 16.5 Ceva Santé VPA10815/061/ 16.5 percent Powder for oral - QJ01FA01 POM: - Erythromycin Full application - Oral use % w/w Soluble Animale 001 weight/weight solution Prescription Only (Article 12(3) of Powder for Oral Medicine as Directive No Solution defined in 2001/82/EC) relevant national legislation

Espacox 50 Industrial VPA10509/005/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Hybrid - Oral use mg/ml oral Veterinaria, S.A. 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(3) of pigs defined in Directive No relevant national 2001/82/EC) legislation

Estrumate Intervet Ireland VPA10996/227/ 0.25 Solution for - QG02AD90 POM: - Cloprostenol Full application - Intramuscular Limited 001 milligram(s)/millil injection Prescription Only sodium (Article 12(3) of use itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Eurican DAP Boehringer VPA10454/038/ . Lyophilisate and - QI07AD02 POM: - Attenuated Full application - Subcutaneous lyophilisate and Ingelheim 001 solvent for Prescription Only canine distemper (Article 12(3) of use solvent for Vetmedica suspension for Medicine as virus, strain ba5 Directive No suspension for GmbH injection defined in - Attenuated 2001/82/EC) injection relevant national canine legislation adenovirus type 2, strain dk13 - Attenuated canine parvovirus, strain cgf

Eurican DAPPi Boehringer VPA10454/039/ . Lyophilisate and - QI07AD04 POM: - Attenuated Full application - Subcutaneous lyophilisate and Ingelheim 001 solvent for Prescription Only canine distemper (Article 12(3) of use solvent for Vetmedica suspension for Medicine as virus, strain ba5 Directive No suspension for GmbH injection defined in - Attenuated 2001/82/EC) injection relevant national canine legislation adenovirus type 2, strain dk13 - Attenuated canine parvovirus, strain cag2 - Attenuated canine parainfluenza virus type 2, strain cgf 2004/75

Veterinary Medicines Authorised/Transfer Pending Products Page 76 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Eurican DHPPi Boehringer VPA10454/040/ . Lyophilisate for - QI07AD04 POM: - Attenuated Full application - Subcutaneous lyophilisate for Ingelheim 001 suspension for Prescription Only canine distemper (Article 12(3) of use suspension for Vetmedica injection Medicine as virus, strain ba5 Directive No injection GmbH defined in - Attenuated 2001/82/EC) relevant national canine legislation adenovirus type 2, strain dk13 - Attenuated canine parvovirus, strain cag2 - Attenuated canine parainfluenza virus type 2, strain cgf 2004/75

Eurican L Boehringer VPA10454/041/ . Suspension for - QI07AB01 POM: - Inactivated Full application - Subcutaneous Ingelheim 001 injection Prescription Only leptospira (Article 12(3) of use Vetmedica Medicine as canicola Directive No GmbH defined in - Inactivated 2001/82/EC) relevant national leptospira legislation icterohaemorrha giae Eurican L multi Boehringer VPA10454/042/ . Suspension for - QI07AB01 POM: - Inactivated Full application - Subcutaneous Suspension for Ingelheim 001 injection Prescription Only leptospira (Article 12(3) of use injection Vetmedica Medicine as interrogans Directive No GmbH defined in serogroup 2001/82/EC) relevant national canicola strain legislation 16070 - Inactivated leptospira interrogans serogroup icterohaemorrha giae strain 16069 - Inactivated leptospira interrogans serogroup grippotyphosa strain mal 1540

Eurofen 100 mg Chanelle VPA10987/117/ 100 milligram(s) Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for Dogs Pharmaceuticals 003 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Eurofen 20 mg Chanelle VPA10987/117/ 20 milligram(s) Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for Dogs Pharmaceuticals 001 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Eurofen 50 mg Chanelle VPA10987/117/ 50 milligram(s) Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for Dogs Pharmaceuticals 002 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Euthanimal 200 Alfasan VPA10980/014/ 200 Solution for - QN51AA01 VPO: Veterinary - Sodium Full application - Intravenous mg/ml, solution Nederland B.V 001 milligram(s)/millil injection Practitioner Only pentobarbital (Article 12(3) of use for injection itre as defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 77 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Euthanimal 400 Alfasan VPA10980/014/ 400 Solution for - QN51AA01 VPO: Veterinary - Sodium Full application - Intravenous mg/ml, solution Nederland B.V 002 milligram(s)/millil injection Practitioner Only pentobarbital (Article 12(3) of use for injection itre as defined in Directive No relevant national 2001/82/EC) legislation

Euthasol vet. Le Vet BV VPA10816/011/ 400 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital Hybrid - Intracardiac 400 mg/ml, 001 milligram(s)/millil injection Practitioner Only application use solution for itre as defined in (Article 13(3) of - Intraperitoneal injection relevant national Directive No use legislation 2001/82/EC) - Intravenous use

EUTHATAL Dopharma VPA10791/012/ 200 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital Full application - Intravenous solution for Research B.V. 001 milligram(s)/millil injection Practitioner Only sodium (Article 12(3) of use injection 200 mg itre as defined in Directive No in 1 ml relevant national 2001/82/EC) legislation

Euthoxin 500 Chanelle VPA10987/115/ 500 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital Hybrid - Intracardiac mg/ml solution Pharmaceuticals 001 milligram(s)/millil injection Practitioner Only application use for injection. Manufacturing itre as defined in (Article 13(3) of - Intraperitoneal Limited relevant national Directive No use legislation 2001/82/EC) - Intra-pulmonary - Intravenous use

Excenel Flow, 50 Zoetis Belgium VPA10387/033/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur ZZZ Complete - Intramuscular mg/ml, S.A. 001 milligram(s)/millil injection Prescription Only application use suspension for itre Medicine as (stand-alone) - - Subcutaneous injection for pigs defined in Council Directive use and cattle relevant national 81/851/EEC legislation

Exidot 100 mg Chanelle VPA10987/138/ 100 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use Spot-on solution Pharmaceuticals 003 Prescription Only application for Medium Dog Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Exidot 250 mg Chanelle VPA10987/138/ 250 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use Spot-on solution Pharmaceuticals 004 Prescription Only application for Large Dogs Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Exidot 40 mg Chanelle VPA10987/138/ 40 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use Spot-on solution Pharmaceuticals 001 Prescription Only application for Small Cats, Manufacturing Medicine as (Article 13(3) of Small Pet Limited defined in Directive No Rabbits & Small relevant national 2001/82/EC) Dogs legislation

Exidot 400 mg Chanelle VPA10987/138/ 400 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use Spot-on solution Pharmaceuticals 005 Prescription Only application for Extra Large Manufacturing Medicine as (Article 13(3) of Dogs Limited defined in Directive No relevant national 2001/82/EC) legislation

Exidot 80 mg Chanelle VPA10987/138/ 80 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use Spot-on solution Pharmaceuticals 002 Prescription Only application for Large Cats Manufacturing Medicine as (Article 13(3) of and Large Pet Limited defined in Directive No Rabbits relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 78 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Exitel 230/20 mg Chanelle VPA10987/103/ 230, 20 Film-coated - QP52AA51 CAM: - Praziquantel Hybrid - Oral use Flavoured Film- Pharmaceuticals 001 mg/tablet tablet Companion - Pyrantel application Coated Tablets Manufacturing Animal Medicine embonate (Article 13(3) of for Cats Limited as defined in Directive No relevant national 2001/82/EC) legislation

Exitel Plus Chanelle VPA10987/078/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use Tablets for Dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application Manufacturing Animal Medicine embonate (Article 10(3) of Limited as defined in - Febantel Directive No relevant national 2001/83/EC) legislation

Exitel Plus XL Chanelle VPA10987/078/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Febantel application Manufacturing - QP52AF02 Animal Medicine - Pyrantel (Article 13(3) of Limited as defined in embonate Directive No relevant national 2001/82/EC) legislation

Exodus Oral Bimeda Animal VPA22033/018/ 400 Oral paste - QP52AF02 POM: - Pyrantel Generic, hybrid - Oral use Paste Health Limited 001 milligram(s)/gra Prescription Only embonate or similar m Medicine as biological defined in application relevant national (Article 13 of legislation Directive No 2001/82/EC) Ezeepour 2.5% Bimeda Animal VPA22033/019/ 2.5 percent Pour-on solution - QP53AC08 POM: - Cypermethrin - Topical use w/v Pour on Health Limited 001 weight/volume Prescription Only technical (93%) Solution Medicine as (cis: trans 50:50) defined in relevant national legislation

Fasifree 10% w/v Bimeda Animal VPA22033/020/ 10 percent Oral suspension - QP52AC01 POM: - Triclabendazole - Oral use Oral Suspension Health Limited 001 weight/volume Prescription Only Medicine as defined in relevant national legislation

Fasinex 240 Elanco GmbH VPA22020/003/ 240 Oral suspension - QP52AC01 POM: - Triclabendazole Full application - Oral use mg/ml oral 001 milligram(s)/millil Prescription Only (Article 12(3) of suspension for itre Medicine as Directive No cattle defined in 2001/82/EC) relevant national legislation

Fasinex 5% w/v Elanco GmbH VPA22020/004/ 5 percent Oral suspension - QP52AC POM: - Triclabendazole Full application - Oral use Oral Suspension 001 weight/volume Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Fasinex Super Elanco GmbH VPA22020/005/ 19.5 percent Oral suspension - QP52A POM: - Triclabendazole - Oral use 19.5% w/v Oral 001 weight/volume Prescription Only - Levamisole Suspension Medicine as hydrochloride defined in relevant national legislation

FATROBENDAN FATRO S.p.A. VPA10836/011/ 1.25 milligram(s) Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use 1.25 mg, 001 Prescription Only application chewable tablets Medicine as (Article 13(3) of for dogs defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 79 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration FATROBENDAN FATRO S.p.A. VPA10836/011/ 10 milligram(s) Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use 10 mg, chewable 003 Prescription Only application tablets for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

FATROBENDAN FATRO S.p.A. VPA10836/011/ 5 milligram(s) Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use 5 mg, chewable 002 Prescription Only application tablets for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Fatromectin 5 ECO Animal VPA22693/006/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin - Topical use mg/ml pour-on Health Europe 001 milligram(s)/millil Prescription Only solution for Limited itre Medicine as cattle. defined in relevant national legislation

Felimazole 1.25 Dechra VPA22622/009/ 1.25 mg/tablet Coated tablet - QH03BB02 POM: - Thiamazole Full application - Oral use mg Coated Regulatory B.V. 003 Prescription Only (Article 12(3) of tablets for cats Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Felimazole 2.5 Dechra VPA22622/009/ 2.5 mg/tablet Coated tablet - QH03BB02 POM: - Thiamazole Full application - Oral use mg Coated Regulatory B.V. 001 Prescription Only (Article 12(3) of Tablets for Cats Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Felimazole 5 mg Dechra VPA22622/009/ 5 mg/tablet Coated tablet - QH03BB02 POM: - Thiamazole - Oral use Coated Tablets Regulatory B.V. 002 Prescription Only for Cats Medicine as defined in relevant national legislation

FELIMINTIC, Domes Pharma VPA10386/002/ 80/20 mg/tablet Tablet - QP52AA51 CAM: - Pyrantel Hybrid - Oral use 80/20 mg tablets SC 001 Companion - Praziquantel application for cats Animal Medicine (Article 13(3) of as defined in Directive No relevant national 2001/82/EC) legislation

Fenafluke 5% Pharvet (Ireland) VPA10462/003/ 50, 50 Oral suspension - QP52AC13 POM: - Fenbendazole Informed - Oral use w/v Oral Ltd 001 milligram(s)/millil - QP52AX Prescription Only - Rafoxanide consent Suspension itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Fenben 10 Oral Ancare Ireland VPA10915/002/ 100 Oral suspension - QP52AC13 POM: - Fenbendazole - Oral use Suspension Ltd. 001 milligram(s)/millil Prescription Only itre Medicine as defined in relevant national legislation

Fenbenor 10 % Pharvet (Ireland) VPA10462/002/ 100 Drench - QP52AC13 POM: - Fenbendazole - Oral use Oral Drench Ltd 001 milligram(s)/millil Prescription Only itre Medicine as defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 80 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Fenbenor 2.5% Pharvet (Ireland) VPA10462/002/ 25 Oral suspension - QP52AC13 POM: - Fenbendazole Informed - Oral use w/v Oral Drench Ltd 002 milligram(s)/millil Prescription Only consent itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Fenflor 300 Krka, d.d., Novo VPA10774/010/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle defined in Directive No use relevant national 2001/82/EC) legislation

Fenflor 300 Krka, d.d., Novo VPA10774/009/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of pigs defined in Directive No relevant national 2001/82/EC) legislation

Fenoflox 100 Chanelle VPA10987/072/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin - Intramuscular mg/ml Solution Pharmaceuticals 002 milligram(s)/millil injection Prescription Only use for Injection for Manufacturing itre Medicine as - Intravenous Cattle and Pigs Limited defined in use relevant national - Subcutaneous legislation use

Fenoflox 50 Chanelle VPA10987/072/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin - Intramuscular mg/ml Solution Pharmaceuticals 001 milligram(s)/millil injection Prescription Only use for Injection for Manufacturing itre Medicine as - Intravenous Cattle, Pigs, Limited defined in use Dogs and Cats relevant national - Subcutaneous legislation use

Fermectin 1 % Chanelle VPA10987/148/ 1 percent Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous Solution for Pharmaceuticals 001 weight/volume injection Prescription Only use Injection for Pigs Manufacturing Medicine as Limited defined in relevant national legislation

Fertigest 0.004 Vetpharma VPA10516/016/ 0.004 Solution for - QH01CA90 POM: - Buserelin Generic - Intramuscular mg/ml Solution Animal Health, 001 milligram(s)/millil injection Prescription Only application use for Injection S.L. itre Medicine as (Article 13(1) of - Subcutaneous defined in Directive No use relevant national 2001/82/EC) legislation

Fertipig HCG 40 Ceva Santé VPA10815/012/ 40/ 80 Lyophilisate and - QG03GA99 POM: - Gonadotrophin, Well-established - Intramuscular IU/ml / PMSG 80 Animale 001 international solvent for Prescription Only equine serum use application use IU/ml lyophilisate unit(s)/millilitre solution for Medicine as (pmsg) (Article 13a of and solvent for injection defined in - Gonadotrophin, Directive No solution for relevant national chorionic (hcg) 2001/82/EC) injection for pigs legislation - Gonadotrophin, equine serum (pmsg) - Gonadotrophin, chorionic (hcg)

Ficoxil 227 mg LIVISTO Int'l, VPA10425/016/ 227 mg/tablet Chewable tablet - QM01AH90 POM: - Firocoxib Generic - Oral use chewable tablets S.L. 002 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 81 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Ficoxil 57 mg LIVISTO Int'l, VPA10425/016/ 57 mg/tablet Chewable tablet - QM01AH90 POM: - Firocoxib Generic - Oral use chewable tablets S.L. 001 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Finadyne 50 Intervet Ireland VPA10996/228/ 50 Solution for - QM01AG90 POM: - Flunixin Full application - Intramuscular mg/ml Solution Limited 001 milligram(s)/millil injection Prescription Only meglumine (Article 12(3) of use for Injection itre Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national legislation

Finadyne Intervet Ireland VPA10996/272/ 50 Pour-on solution - QM01AG90 POM: - Flunixin Full application - Topical use Transdermal 50 Limited 001 milligram(s)/millil Prescription Only meglumine (Article 12(3) of mg/ml pour-on itre Medicine as Directive No solution for cattle defined in 2001/82/EC) relevant national legislation

Finilac 50 Le Vet Beheer VPA10475/015/ 50 Oral solution - QG02CB03 POM: - Cabergoline Generic - Oral use microgram/ml B.V. 001 microgram(s)/mil Prescription Only application oral solution for lilitre Medicine as (Article 13(1) of dogs and cats defined in Directive No relevant national 2001/82/EC) legislation

Fipnil 134 mg Chanelle VPA10987/095/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 002 Prescription Only application for medium dogs Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Fipnil 268 mg Chanelle VPA10987/095/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 003 Prescription Only application for large dogs Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Fipnil 402 mg Chanelle VPA10987/095/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 004 Prescription Only application for extra large Manufacturing Medicine as (Article 13(3) of dogs Limited defined in Directive No relevant national 2001/82/EC) legislation

Fipnil 50 mg Chanelle VPA10987/096/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-on solution Pharmaceuticals 001 Prescription Only application for Cats Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Fipnil 67 mg Chanelle VPA10987/095/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 001 Prescription Only application for small dogs Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

FIPREX DUO 50 Vet-Agro Multi- VPA20742/005/ 50,60 mg/pipette Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use mg+ 60 mg spot- Trade Company 001 Prescription Only - (S)-methopene application on solution for Sp z o.o. Medicine as (Article 13(3) of cats and ferrets defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 82 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Fiprex Duo L 268 Vet-Agro Multi- VPA20742/004/ 268,241.2 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use mg + 241.2 mg trade company 003 mg/pipette Prescription Only - (S)-methoprene application spot-on solution Sp z o.o. Medicine as (Article 13(3) of for dogs defined in Directive No relevant national 2001/82/EC) legislation

Fiprex Duo M Vet-Agro Multi- VPA20742/004/ 134,120.6 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 134 mg + 120.6 trade company 002 mg/pipette Prescription Only - (S)-methoprene application mg spot-on Sp z o.o. Medicine as (Article 13(3) of solution for dogs defined in Directive No relevant national 2001/82/EC) legislation

FIPREX DUO S Vet-Agro Multi- VPA20742/004/ 67,60.3 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 67 mg + 60.3 mg trade company 001 mg/pipette Prescription Only - (S)-methoprene application spot-on solution Sp z o.o. Medicine as (Article 13(3) of for dogs defined in Directive No relevant national 2001/82/EC) legislation

Fiprex Duo XL Vet-Agro Multi- VPA20742/004/ 402,361.8 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 402 mg + 361.8 trade company 004 mg/pipette Prescription Only - (S)-methoprene application mg spot-on Sp z o.o. Medicine as (Article 13(3) of solution for dogs defined in Directive No relevant national 2001/82/EC) legislation

Fiproclear 134 Norbrook VPA22664/107/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use mg Spot-On Laboratories 002 Prescription Only application Solution for (Ireland) Limited Medicine as (Article 13(3) of Medium Dogs defined in Directive No relevant national 2001/82/EC) legislation

Fiproclear 268 Norbrook VPA22664/107/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use mg Spot-On Laboratories 003 Prescription Only application Solution for (Ireland) Limited Medicine as (Article 13(3) of Large Dogs defined in Directive No relevant national 2001/82/EC) legislation

Fiproclear 402 Norbrook VPA22664/107/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use mg Spot-On Laboratories 004 Prescription Only application Solution for Very (Ireland) Limited Medicine as (Article 13(3) of Large Dogs defined in Directive No relevant national 2001/82/EC) legislation

Fiproclear 50 mg Norbrook VPA22664/108/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 001 Prescription Only application for Cats (Ireland) Limited Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Fiproclear 67 mg Norbrook VPA22664/107/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 001 Prescription Only application for Small Dogs (Ireland) Limited Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Fiproclear Norbrook VPA22664/137/ 134/120.6 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use Combo 134 mg / Laboratories 002 mg/pipette Merchant as - (S)-methopene application 120.6 mg spot- (Ireland) Limited defined in (Article 13(1) of on solution for relevant national Directive No medium dogs legislation 2001/82/EC)

Fiproclear Norbrook VPA22664/137/ 268/241.2 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use Combo 268 mg / Laboratories 003 mg/pipette Merchant as - (S)-methopene application 241.2 mg spot- (Ireland) Limited defined in (Article 13(1) of on solution for relevant national Directive No large dogs legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 83 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Fiproclear Norbrook VPA22664/137/ 402/361.8 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use Combo 402 mg / Laboratories 004 mg/pipette Merchant as - (S)-methopene application 361.8 mg spot- (Ireland) Limited defined in (Article 13(1) of on solution for relevant national Directive No very large dogs legislation 2001/82/EC)

Fiproclear Norbrook VPA22664/134/ 50/60 mg/pipette Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use Combo 50 mg / Laboratories 001 Merchant as - (S)-methopene application 60 mg spot-on (Ireland) Limited defined in (Article 13(1) of solution for cats relevant national Directive No and ferrets legislation 2001/82/EC)

Fiproclear Norbrook VPA22664/137/ 67/60.3 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use Combo 67 mg / Laboratories 001 mg/pipette Merchant as - (S)-methopene application 60.3 mg spot-on (Ireland) Limited defined in (Article 13(1) of solution for small relevant national Directive No dogs legislation 2001/82/EC)

Firodyl 250 mg Ceva Santé VPA10815/057/ 250 mg/tablet Chewable tablet - QM01AH90 POM: - Firocoxib Hybrid - Oral use chewable tablets Animale 002 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Firodyl 62.5 mg Ceva Santé VPA10815/057/ 62.5 mg/tablet Chewable tablet - QM01AH90 POM: - Firocoxib Hybrid - Oral use chewable tablets Animale 001 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Fixplan 200 Syn Vet-Pharma VPA23174/002/ 200 international Lyophilisate and - QG03GA03 POM: - Gonadotrophin, Generic - Intramuscular IU/ml lyophilisate Ireland Limited 001 unit(s)/millilitre solvent for Prescription Only Equine Serum, application use and solvent for solution for Medicine as For Veterinary (Article 13(1) of - Subcutaneous solution for injection defined in Use Directive No use injection relevant national 2001/82/EC) legislation

Fleanil 134 mg Norbrook VPA22664/105/ 134 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 002 Merchant as application for Medium Dog (Ireland) Limited defined in (Article 13(3) of relevant national Directive No legislation 2001/82/EC)

FLEANIL 2.5 Norbrook VPA22664/002/ 2.5 Cutaneous - QP53AX15 POM: - Fipronil Generic - Topical use mg/ml Laboratories 001 milligram(s)/millil spray, solution Prescription Only application Cutaneous (Ireland) Limited itre Medicine as (Article 13(1) of Spray, Solution defined in Directive No for Cats and relevant national 2001/82/EC) Dogs legislation

Fleanil 268 mg Norbrook VPA22664/105/ 268 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 003 Merchant as application for Large Dogs (Ireland) Limited defined in (Article 13(3) of relevant national Directive No legislation 2001/82/EC)

Fleanil 402 mg Norbrook VPA22664/105/ 402 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 004 Merchant as application for Very Large (Ireland) Limited defined in (Article 13(3) of Dogs relevant national Directive No legislation 2001/82/EC)

Fleanil 50 mg Norbrook VPA22664/106/ 50.0 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Generic, hybrid - Topical use Spot-On Solution Laboratories 001 Merchant as or similar for Cats (Ireland) Limited defined in biological relevant national application legislation (Article 13 of Directive No 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 84 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Fleanil 67 mg Norbrook VPA22664/105/ 67 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 001 Merchant as application for Small Dogs (Ireland) Limited defined in (Article 13(3) of relevant national Directive No legislation 2001/82/EC)

Fleanil Combo Norbrook VPA22664/136/ 134, 120.6 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use 134 mg / 120.6 Laboratories 002 mg/pipette Merchant as - S-methoprene application mg spot-on (Ireland) Limited defined in (Article 13(1) of solution for relevant national Directive No medium dogs legislation 2001/82/EC)

Fleanil Combo Norbrook VPA22664/136/ 268, 241.2 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use 268 mg / 241.2 Laboratories 003 mg/pipette Merchant as - (S)-methopene application mg spot-on (Ireland) Limited defined in (Article 13(1) of solution for large relevant national Directive No dogs legislation 2001/82/EC)

Fleanil Combo Norbrook VPA22664/136/ 402, 361.8 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use 402 mg / 361.8 Laboratories 004 mg/pipette Merchant as - S-methoprene application mg spot-on (Ireland) Limited defined in (Article 13(1) of solution for very relevant national Directive No large dogs legislation 2001/82/EC)

Fleanil Combo Norbrook VPA22664/132/ 50, 60 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use 50 mg / 60 mg Laboratories 001 mg/pipette Merchant as - (S)-methoprene application spot-on solution (Ireland) Limited defined in (Article 13(1) of for cats and relevant national Directive No ferrets legislation 2001/82/EC)

Fleanil Combo Norbrook VPA22664/136/ 67, 60.3 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use 67 mg / 60.3 mg Laboratories 001 mg/pipette Merchant as - (S)-methoprene application spot-on solution (Ireland) Limited defined in (Article 13(1) of for small dogs relevant national Directive No legislation 2001/82/EC)

Fleatix 134 mg Chanelle VPA10987/106/ 134 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 002 Merchant as application for medium dogs Manufacturing defined in (Article 13(3) of Limited relevant national Directive No legislation 2001/82/EC)

Fleatix 268 mg Chanelle VPA10987/106/ 268 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 003 Merchant as application for large dogs Manufacturing defined in (Article 13(3) of Limited relevant national Directive No legislation 2001/82/EC)

Fleatix 402 mg Chanelle VPA10987/106/ 402 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 004 Merchant as application for extra large Manufacturing defined in (Article 13(3) of dogs Limited relevant national Directive No legislation 2001/82/EC)

Fleatix 50 mg Chanelle VPA10987/105/ 50 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use Spot on solution Pharmaceuticals 001 Merchant as application for cats Manufacturing defined in (Article 13(3) of Limited relevant national Directive No legislation 2001/82/EC)

Fleatix 67 mg Chanelle VPA10987/106/ 67 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 001 Merchant as application for small dogs Manufacturing defined in (Article 13(3) of Limited relevant national Directive No legislation 2001/82/EC)

Fleatix Combo Chanelle VPA10987/106/ 134, 120.6 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Hybrid - Spot-on use 134 mg/120.6 Pharmaceuticals 008 mg/pipette Merchant as - (S)-methoprene application mg Spot-on Manufacturing defined in (Article 13(3) of Solution for Limited relevant national Directive No Medium Dogs legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 85 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Fleatix Combo Chanelle VPA10987/106/ 268, 241.2 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Hybrid - Spot-on use 268 mg/241.2 Pharmaceuticals 007 mg/pipette Merchant as - (S)-methoprene application mg Spot-on Manufacturing defined in (Article 13(3) of Solution for Limited relevant national Directive No Large Dogs legislation 2001/82/EC)

Fleatix Combo Chanelle VPA10987/106/ 402, 361.8 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Hybrid - Spot-on use 402 mg/361.8 Pharmaceuticals 006 mg/pipette Merchant as - (S)-methoprene application mg Spot-on Manufacturing defined in (Article 13(3) of Solution for Extra Limited relevant national Directive No Large Dogs legislation 2001/82/EC)

Fleatix Combo Chanelle VPA10987/106/ 50, 60 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Hybrid - Spot-on use 50 mg/60 mg Pharmaceuticals 009 mg/pipette Merchant as - (S)-methoprene application Spot-on Solution Manufacturing defined in (Article 13(3) of for Cats and Limited relevant national Directive No Ferrets legislation 2001/82/EC)

Fleatix Combo Chanelle VPA10987/106/ 67, 60.3 Spot-on solution - QP53AX65 LM: Licensed - (S)-methoprene Hybrid - Spot-on use 67 mg/60.3 mg Pharmaceuticals 005 mg/pipette Merchant as - Fipronil application Spot-on Solution Manufacturing defined in (Article 13(3) of for Small Dogs Limited relevant national Directive No legislation 2001/82/EC)

Flectron Fly Zoetis Belgium VPA10387/034/ 935 Ear tag - QP53AC08 POM: - Cypermethrin Full application - Topical use Tags 935 mg S.A. 001 milligram(s)/tag Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Flexiben 10% Bimeda Animal VPA22033/021/ 10 percent Oral suspension - QP52AC11 POM: - Albendazole Informed - Oral use SC Oral Health Limited 001 weight/volume Prescription Only consent Suspension Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

FLIMABEND 100 Krka, d.d., Novo VPA10774/015/ 100 Oral suspension - QP52AC12 POM: - Flubendazole Hybrid - Oral use mg/g suspension mesto 001 milligram(s)/gra Prescription Only application for use in m Medicine as (Article 13(3) of drinking water for defined in Directive No chickens and relevant national 2001/82/EC) pigs legislation

Flordofen 300 Dopharma VPA10791/006/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular mg/ml Solution Research B.V. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle and pigs defined in Directive No use relevant national 2001/82/EC) legislation

FLORFENIKEL Kela n.v. VPA10981/013/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular 300 mg/ml 001 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle and pigs relevant national 2001/82/EC) legislation

FLORFENIS 300 Laboratorios VPA10495/007/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular mg/ml solution SYVA, S.A.U 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle, sheep and defined in Directive No use pigs relevant national 2001/82/EC) legislation

Florgane 300 Emdoka bvba VPA10534/001/ 300 Suspension for - QJ01BA90 POM: - Florfenicol Hybrid - Intramuscular mg/ml 001 milligram(s)/millil injection Prescription Only application use Suspension for itre Medicine as (Article 13(3) of Injection for defined in Directive No Cattle and Pigs relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 86 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration FLORINJECT LABORATORIO VPA10665/006/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular 300 mg/ml S CALIER S.A. 001 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(1) of - Subcutaneous injection for defined in Directive No use cattle and pigs relevant national 2001/82/EC) legislation

Florkem 300 Ceva Santé VPA10815/008/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular mg/ml solution Animale 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of cattle and pigs defined in Directive No relevant national 2001/82/EC) legislation

FLOROLAB 100 Labiana Life VPA10402/003/ 100 Solution for use - QJ01BA90 POM: - Florfenicol Hybrid - Per Oral mg/ml solution Sciences, S.A. 001 milligram(s)/millil in drinking water Prescription Only application for use in itre Medicine as (Article 13(3) of drinking water for defined in Directive No pigs relevant national 2001/82/EC) legislation

Floxabactin 15 Le Vet BV VPA10816/006/ 15 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg tablets for 001 Prescription Only application cats and dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Floxabactin 150 Le Vet BV VPA10816/006/ 150 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg tablets for 003 Prescription Only application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Floxabactin 50 Le Vet BV VPA10816/006/ 50 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg tablets for 002 Prescription Only application dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Floxamax 100 SP Veterinaria, VPA10790/002/ 100 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml S.A. 001 milligram(s)/millil Prescription Only application concentrate for itre Medicine as (Article 13(1) of oral solution for defined in Directive No chickens and relevant national 2001/82/EC) turkeys legislation

Floxibac 100 Chanelle VPA10987/071/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin - Intramuscular mg/ml Solution Pharmaceuticals 002 milligram(s)/millil injection Prescription Only use for Injection for Manufacturing itre Medicine as - Intravenous Cattle and Pigs Limited defined in use relevant national - Subcutaneous legislation use

Floxibac 50 Chanelle VPA10987/071/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin - Intramuscular mg/ml Solution Pharmaceuticals 001 milligram(s)/millil injection Prescription Only use for Injection for Manufacturing itre Medicine as - Intravenous Cattle, Pigs, Limited defined in use Dogs and Cats relevant national - Subcutaneous legislation use

Flubendazole Elanco GmbH VPA22020/037/ 50 Oral powder - QP52AC12 POM: - Flubendazole Generic - Oral use Elanco 50 mg/g 001 milligram(s)/gra Prescription Only application oral powder for m Medicine as (Article 13(1) of pigs defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 87 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Flubenol 5 % Elanco GmbH VPA22020/006/ 5 percent Premix for - QP52AC12 POM: - Flubendazole - Oral use w/w Premix for 001 weight/weight medicated Prescription Only Medicated feeding stuff Medicine as Feeding Stuff defined in relevant national legislation

Flubenol 5 %w/w Elanco GmbH VPA22020/028/ 5 percent Oral powder - QP52AC12 POM: - Flubendazole Full application - Oral use Oral Powder for 001 weight/weight Prescription Only (Article 12(3) of Pigs Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Flukiver 5% w/v Elanco GmbH VPA22020/001/ 5 percent Oral suspension - QP52AG09 POM: - Closantel ZZZ Complete - Oral use Oral Suspension 001 weight/volume Prescription Only sodium application Medicine as (stand-alone) - defined in Council Directive relevant national 81/851/EEC legislation

Flukiver 50 Elanco GmbH VPA22020/002/ 50 Solution for - QP52AG09 POM: - Closantel ZZZ Complete - Subcutaneous mg/ml Solution 001 milligram(s)/millil injection Prescription Only sodium application use for Injection itre Medicine as (stand-alone) - defined in Council Directive relevant national 81/851/EEC legislation

Flukiver Combi Elanco GmbH VPA22020/039/ 50, 75 Oral suspension - QP52A POM: - Mebendazole Generic - Oral use 50 mg/ml + 75 001 milligram(s)/millil Prescription Only - Closantel application mg/ml oral itre Medicine as sodium dihydrate (Article 13(1) of suspension defined in Directive No relevant national 2001/82/EC) legislation

Flunazine 50 Bimeda Animal VPA22033/061/ 50 Solution for - QM01AG90 POM: - Flunixin - Intravenous mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only meglumine use for Injection for itre Medicine as cattle, horses defined in and pigs relevant national legislation

Flunixin Injection Norbrook VPA22664/046/ 50 Solution for - QM01AG90 POM: - Flunixin Generic - Intramuscular Laboratories 001 milligram(s)/millil injection Prescription Only meglumine application use (Ireland) Limited itre Medicine as (Article 13(1) of - Intravenous defined in Directive No use relevant national 2001/82/EC) legislation

Fly and Lice Zoetis Belgium VPA10387/048/ 1 percent Spot-on solution - QP53AC11 POM: - Deltamethrin Full application - Topical use Spot On S.A. 001 weight/volume Prescription Only (Article 12(3) of Insecticide 1% Medicine as Directive No w/v defined in 2001/82/EC) relevant national legislation

Folligon PMSG Intervet Ireland VPA10996/055/ 200 international Powder and - QG03GA03 POM: - Gonadotrophin Full application - Intramuscular 200 IU/ml Limited 001 unit(s)/millilitre solvent for Prescription Only (Article 12(3) of use lyophilisate and suspension for Medicine as Directive No - Subcutaneous solvent for injection defined in 2001/82/EC) use solution for relevant national injection legislation

Folliplan, 4 Intervet Ireland VPA10996/275/ 4 Oral solution - QG03DX90 POM: - Altrenogest Generic - Oral use mg/ml oral Limited 001 milligram(s)/millil Prescription Only application solution for pigs itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 88 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Folltropin 700 IU Vetoquinol VPA10983/050/ 700 international Powder and - QG03GA90 POM: - Porcine follicle Full application - Intramuscular Powder and Ireland Limited 001 unit/vial solvent for Prescription Only stimulating (Article 12(3) of use Solvent for solution for Medicine as hormone Directive No solution for injection defined in 2001/82/EC) injection relevant national legislation

Footvax Intervet Ireland VPA10996/232/ .
Emulsion for - QI04AB03 POM: - Dichelobacter Generic - Subcutaneous Emulsion for Limited 001 injection Prescription Only nodosus application use Injection for Medicine as serotype I (Article 13(1) of Sheep defined in - Dichelobacter Directive No relevant national nodosus 2001/82/EC) legislation 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 Forcyl 160 mg/ml Vetoquinol VPA10983/051/ 160 Solution for - QJ01MA93 POM: - Marbofloxacin Full application - Intramuscular solution for Ireland Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use injection for itre Medicine as Directive No - Intravenous cattle defined in 2001/82/EC) use relevant national legislation

FORCYL swine Vetoquinol VPA10983/052/ 160 Solution for - QJ01MA93 POM: - Marbofloxacin Full application - Intramuscular 160 mg/ml Ireland Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use solution for itre Medicine as Directive No injection for pigs defined in 2001/82/EC) relevant national legislation

Forespix 100 Vet-Agro Multi- VPA20742/006/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular mg/ml solution Trade Company 001 milligram(s)/millil injection Prescription Only application use for injection for Sp z o.o. itre Medicine as (Article 13(1) of - Subcutaneous cattle, pigs and defined in Directive No use sheep relevant national 2001/82/EC) legislation

Formicpro 68.2g NOD Apiary VPA22670/002/ 68.2 Bee-hive strip - QP53AG01 LM: Licensed - Formic acid Full application - Inhalation use Beehive Strips Ireland Ltd 001 gram(s)/strip Merchant as (Article 12(3) of for Honey Bees defined in Directive No relevant national 2001/82/EC) legislation

Fortekor 2.5 mg Elanco GmbH VPA22020/017/ 2.5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use tablets for cats 001 Prescription Only hydrochloride application and dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 89 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Fortekor Flavour Elanco GmbH VPA22020/018/ 20 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use 20 mg Tablets 002 Prescription Only hydrochloride application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Fortekor Flavour Elanco GmbH VPA22020/018/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use 5 mg Tablets for 001 Prescription Only hydrochloride application cats and dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Fortemec 1 % Ancare Ireland VPA10915/011/ 1 percent Pour-on solution - QP54AA02 POM: - Abamectin Informed - Topical use w/v Pour On Ltd. 001 weight/volume Prescription Only consent Solution Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Framomycin 150 Elanco GmbH VPA22020/025/ 150 Solution for - QJ01GB POM: - Framycetin Full application - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only sulphate (Article 12(3) of use for Injection itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Frontline Combo Boehringer VPA10454/046/ 50, 60 Spot-on solution - QP53AX65 POM: - Fipronil - Topical use Spot-on Cat Ingelheim 001 mg/pipette Prescription Only - (S)-methoprene Vetmedica Medicine as GmbH defined in relevant national legislation

Frontline Combo Boehringer VPA10454/047/ 268.0, 241.2 Spot-on solution - QP53AX65 POM: - Fipronil - Topical use Spot-on Dog L Ingelheim 003 mg/pipette Prescription Only - (S)-methoprene Vetmedica Medicine as GmbH defined in relevant national legislation

Frontline Combo Boehringer VPA10454/047/ 134.0, 120.6 Spot-on solution - QP53AX65 POM: - Fipronil - Topical use Spot-on Dog M Ingelheim 002 mg/pipette Prescription Only - (S)-methoprene Vetmedica Medicine as GmbH defined in relevant national legislation

Frontline Combo Boehringer VPA10454/047/ 67.0, 60.3 Spot-on solution - QP53AX65 POM: - Fipronil - Topical use Spot-on Dog S Ingelheim 001 mg/pipette Prescription Only - (S)-methoprene Vetmedica Medicine as GmbH defined in relevant national legislation

Frontline Combo Boehringer VPA10454/047/ 402.0, 361.8 Spot-on solution - QP53AX65 POM: - Fipronil - Topical use Spot-on Dog XL Ingelheim 004 mg/pipette Prescription Only - (S)-methoprene Vetmedica Medicine as GmbH defined in relevant national legislation

Frontline Spot Boehringer VPA10454/048/ 10 percent Spot-on solution - QP53AX15 POM: - Fipronil Full application - Topical use On Cat Ingelheim 001 weight/volume Prescription Only (Article 12(3) of Vetmedica Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 90 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Frontline Spot Boehringer VPA10454/049/ 10 percent Spot-on solution - QP53AX15 POM: - Fipronil Full application - Topical use On Dog Ingelheim 001 weight/volume Prescription Only (Article 12(3) of Vetmedica Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

Frontline Spray Boehringer VPA10454/050/ 0.25 percent Cutaneous - QP53AX15 POM: - Fipronil Full application - Cutaneous use 0.25 %w/v Ingelheim 001 weight/volume spray, solution Prescription Only (Article 12(3) of Vetmedica Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

Fungiconazol Le Vet Beheer VPA10475/012/ 200 mg/tablet Tablet - QJ02AB02 POM: - Ketoconazole Generic - Oral use 200 mg tablets B.V. 001 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Fungiconazol Le Vet Beheer VPA10475/012/ 400 mg/tablet Tablet - QJ02AB02 POM: - Ketoconazole Generic - Oral use 400 mg tablets B.V. 002 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Furosoral 10 mg Le Vet Beheer VPA10475/017/ 10 mg/tablet Tablet - QC03CA01 POM: - Furosemide Hybrid - Oral use tablets for cats B.V. 001 Prescription Only application and dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Furosoral 40 mg Le Vet Beheer VPA10475/017/ 40 mg/tablet Tablet - QC03CA01 POM: - Furosemide Generic - Oral use tablets for cats B.V. 002 Prescription Only application and dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Fuselieve 1 mg/g Norbrook VPA22664/147/ 1,5 Gel - QD07CC01 POM: - Betamethasone Hybrid - Topical use + 5 mg/g Gel for Laboratories 001 milligram(s)/gra Prescription Only valerate application Dogs (Ireland) Limited m Medicine as - Fusidic acid (Article 13(3) of defined in hemihydrate Directive No relevant national 2001/82/EC) legislation

Gabbrovet 140 Ceva Santé VPA10815/050/ 140 Solution for use - QA07AA06 POM: - Paromomycin Generic - Oral use mg/ml solution Animale 001 milligram(s)/millil in drinking water, Prescription Only application for use in itre Milk or milk Medicine as (Article 13(1) of drinking water, replacer defined in Directive No milk or milk relevant national 2001/82/EC) replacer for pre- legislation ruminant cattle and pigs Gallifen 200 Huvepharma NV VPA10782/030/ 200 Suspension for - QP52AC13 POM: - Fenbendazole Hybrid - In drinking mg/ml 001 milligram(s)/millil use in drinking Prescription Only application water use suspension for itre water Medicine as (Article 13(3) of use in drinking defined in Directive No water for relevant national 2001/82/EC) chickens and legislation pheasants Gallifen 40 mg/g Huvepharma NV VPA10782/022/ 40 Premix for - QP52AC13 POM: - Fenbendazole Hybrid - Oral use premix for 001 milligram(s)/gra medicated Prescription Only application medicated m feeding stuff Medicine as (Article 13(3) of feeding stuff for defined in Directive No chickens and relevant national 2001/82/EC) pheasants legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 91 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration GALLIMUNE Boehringer VPA10454/051/ . Emulsion for - QI01AA13 POM: - Inactivated Full application - Intramuscular 302 ND+IB+EDS Ingelheim 001 injection Prescription Only newcastle (Article 12(3) of use Vetmedica Medicine as disease virus, Directive No GmbH defined in ulster 2c strain 2001/82/EC) relevant national - Inactivated legislation infectious bronchitis virus, mass41 strain - Inactivated egg drop syndrome virus (eds76), v127 strain

GALLIMUNE Boehringer VPA10454/052/ . Emulsion for - QI01AA21 POM: - Inactivated Full application - Intramuscular 303 ND+IB+ART Ingelheim 001 injection Prescription Only newcastle (Article 12(3) of use Emulsion for Vetmedica Medicine as disease virus, Directive No injection GmbH defined in ulster 2c strain 2001/82/EC) relevant national - Inactivated legislation infectious bronchitis virus, mass41 strain - Inactivated avian rhinotracheitis virus (swollen head syndrome), vco3 strain

GALLIMUNE Boehringer VPA10454/053/ . Emulsion for - QI01AA18 POM: - Inactivated Full application - Intramuscular 407 Ingelheim 001 injection Prescription Only newcastle (Article 12(3) of use ND+IB+EDS+A Vetmedica Medicine as disease virus, Directive No RT Emulsion for GmbH defined in ulser 2C strain, 2001/82/EC) injection relevant national at least legislation - 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

Gallimune Se + Boehringer VPA10454/054/ . Emulsion for - QI01AB01 POM: - Inactivated Full application - Intramuscular St, water-in-oil Ingelheim 001 injection Prescription Only Salmonella (Article 12(3) of use emulsion for Vetmedica Medicine as Enteritidis PT4 Directive No injection GmbH defined in - Inactivated 2001/82/EC) relevant national Salmonella legislation Typhimurium DT 104 GALLIVAC IB88 Boehringer VPA10454/056/ . Effervescent - QI01AD07 POM: - Live attenuated Full application - Nebulisation NEO Ingelheim 001 tablet Prescription Only coronavirus, (Article 12(3) of use effervescent Vetmedica Medicine as CR88121 strain Directive No tablet for GmbH defined in 2001/82/EC) suspension for relevant national nebulisation for legislation chickens GALLIVAC IBD Boehringer VPA10454/057/ . Lyophilisate for - QI01AD09 POM: - Infectious Full application - Inhalation use Ingelheim 001 suspension Prescription Only bursal disease (Article 12(3) of - Oral use Vetmedica Medicine as virus, attenuated Directive No GmbH defined in strain S706 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 92 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Gallivac IBD Boehringer VPA10454/079/ . Effervescent - QI01AD09 POM: - Avian infectious New active - Oral use S706 NEO Ingelheim 001 tablet Prescription Only bursal disease substance Effervescent Vetmedica Medicine as virus, live (Article 12(3) of tablet for use in GmbH defined in Directive No drinking water for relevant national 2001/82/EC) chickens legislation

GalluDoxx 500 Huvepharma NV VPA10782/023/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Generic - In drinking mg/g powder for 001 milligram(s)/gra in drinking water Prescription Only hyclate application water use use in drinking m Medicine as (Article 13(1) of water/milk defined in Directive No replacer for relevant national 2001/82/EC) calves, chickens legislation and turkeys

Gastazole 370 Chanelle VPA10987/124/ 370 Oral paste - QA02BC01 POM: - Omeprazole Generic - Oral use mg/g oral paste Pharmaceuticals 001 milligram(s)/gra Prescription Only application for horses Manufacturing m Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Gastrobim 370 Bimeda Animal VPA22033/072/ 370 Oral paste - QA02BC01 POM: - Omeprazole Generic - Oral use mg/g oral paste Health Limited 001 milligram(s)/gra Prescription Only application for horses m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

GastroGard 370 Boehringer VPA10454/058/ 370 Oral paste - QA02BC01 POM: - Omeprazole Full application - Oral use mg/g oral paste Ingelheim 001 milligram(s)/gra Prescription Only (Article 12(3) of Vetmedica m Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

GEFRIDERM ALPHA-VET VPA10391/003/ 1.025, 2.041, Cutaneous - QD07CA03 POM: - Marbofloxacin Full application - Cutaneous use cutaneous spray Állatgyógyászati 001 0.926 spray, solution Prescription Only - Ketoconazole (Article 12(3) of solution for dogs Kft. milligram(s)/millil Medicine as - Prednisolone Directive No itre defined in 2001/82/EC) relevant national legislation

Genesis 1% Ancare Ireland VPA10915/007/ 1 percent Pour-on solution - QP54AA POM: - Abamectin - Topical use Pour-on Solution Ltd. 001 weight/volume Prescription Only Medicine as defined in relevant national legislation

Genesis Sheep Ancare Ireland VPA10915/009/ 0.8 Oral solution - QP54AA02 POM: - Abamectin Full application - Oral use Drench 0.8 Ltd. 001 milligram(s)/millil Prescription Only (Article 12(3) of mg/ml abamectin itre Medicine as Directive No oral solution defined in 2001/82/EC) relevant national legislation

Genestran 75 aniMedica VPA10826/010/

75

Solution for - QG02AD90 POM: - (+)- Well-established - Intramuscular micrograms/ml GmbH 001 microgram(s)/mil injection Prescription Only closprostenol use application use solution for lilitre Medicine as sodium salt (Article 13a of injection for defined in Directive No cattle, horses relevant national 2001/82/EC) and pigs legislation

Genta 50 mg/ml Kela n.v. VPA10981/011/ 50 Solution for - QJ01GB03 POM: - Gentamicin ZZZ Informed - Intramuscular solution for 001 milligram(s)/millil injection Prescription Only sulphate consent use injection itre Medicine as (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

Veterinary Medicines Authorised/Transfer Pending Products Page 93 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Gentaject 10% Franklin VPA10976/002/ 100 Solution for - QJ01GB03 POM: - Gentamicin Full application - Intravenous Solution for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use Injection for Ltd. itre Medicine as Directive No Horses defined in 2001/82/EC) relevant national legislation

Gleptoferron Labiana Life VPA10402/001/ 200 Solution for - QB03AC91 LM: Licensed - Gleptoferron Generic - Intramuscular Labiana 200 Sciences, S.A. 001 milligram(s)/millil injection Merchant as application use mg/ml Solution itre defined in (Article 13(1) of for Injection relevant national Directive No legislation 2001/82/EC)

Gleptosil 200 Ceva Santé VPA10815/027/ 200 Solution for - QB03AC91 LM: Licensed - Gleptoferron ZZZ Complete - Intramuscular mg/ml Solution Animale 001 milligram(s)/millil injection Merchant as application use for Injection itre defined in (stand-alone) - relevant national Council Directive legislation 81/851/EEC

GLEPTOVEX SP Veterinaria, VPA10790/010/ 200 Solution for - QB03AC91 LM: Licensed - Iron Generic - Intramuscular 200 mg/ml S.A. 001 milligram(s)/millil injection Merchant as application use solution for itre defined in (Article 13(1) of injection for pigs relevant national Directive No legislation 2001/82/EC)

GLETVAX 6 Zoetis Belgium VPA10387/035/ . Suspension for - QI09AB08 LM: Licensed - E.coli k88ab Full application - Intramuscular S.A. 001 injection Merchant as antigen (Article 12(3) of use defined in - E.coli k88ac Directive No - Subcutaneous relevant national antigen 2001/82/EC) use legislation - E.coli k99 antigen - E.coli 987p antigen - Purified toxoids of Cl. perfringens

Glucadex 2 Kepro BV VPA22633/001/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular mg/ml solution 001 milligram(s)/millil injection Prescription Only Dexamethasone application use for injection for itre Medicine as (Article 13(1) of - Intramuscular horses, cattle, defined in Directive No use goats, pigs, dogs relevant national 2001/82/EC) - Intravenous and cats legislation use - Periarticular use - Subcutaneous use Glucose 5g/100 B. Braun VPA10465/001/ 5 grams/100 Solution for - QB05B POM: - Glucose Well-established - Intravenous ml B. Braun Vet Melsungen AG 001 millilitres infusion Prescription Only monohydrate use application use Care solution for Medicine as (Article 13a of infusion for defined in Directive No cattle, horse, relevant national 2001/82/EC) sheep, goat, pig, legislation dog and cat Gold Fleece Bimeda Animal VPA22033/023/ 60 percent Concentrate for - QP53AF03 POM: - Dimpylate - Topical use Sheep Dip 60 % Health Limited 001 weight/weight dip solution Prescription Only (Diazinon w/w Concentrate Medicine as Stabilised for Dip Solution defined in Technical) relevant national legislation

Golden Udder Collective VPA10914/001/ 10, 1.5 percent Gel - QD11AC08 LM: Licensed - Sulphur for - Topical use Gel Chemical 001 weight/volume Merchant as external use Company Ltd. defined in - Salicylic acid relevant national legislation

Gonavet Veyx 50 Veyx-Pharma VPA10539/004/ 50 Solution for - QH01CA01 POM: - Gonadorelin [6- Generic - Intramuscular micrograms/ml GmbH 001 microgram(s)/mil injection Prescription Only D-Phe] application use solution for lilitre Medicine as (Article 13(1) of - Subcutaneous injection for defined in Directive No use cattle, pigs and relevant national 2001/82/EC) horses legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 94 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Gullivers Flea & Chanelle VPA10987/055/ 3.9 Collar - QP53AF03 CAM: - Dimpylate - Topical use Tick Collar for Pharmaceuticals 001 gram(s)/collar Companion dogs Manufacturing Animal Medicine Limited as defined in relevant national legislation

Gulliver's Flea Chanelle VPA10987/014/ 2.1 Collar - QP53AF03 CAM: - Dimpylate - Topical use Collar for Cats Pharmaceuticals 001 gram(s)/collar Companion Manufacturing Animal Medicine Limited as defined in relevant national legislation

Gullivers Flea Chanelle VPA10987/040/ 0.05, 0.5 percent Shampoo - QP53AC30 CAM: - Pyrethrins - Topical use Shampoo Pharmaceuticals 001 weight/volume Companion - Piperonyl Manufacturing Animal Medicine butoxide Limited as defined in relevant national legislation

Gutal 1000 mg/g Huvepharma NV VPA10782/016/ 1000 Premix for - QA07XA91 POM: - Zinc oxide Generic - Oral use premix for 001 milligram(s)/gra medicated Prescription Only application medicated m feeding stuff Medicine as (Article 13(1) of feeding stuff for defined in Directive No piglets relevant national 2001/82/EC) legislation

Halofusol 0.5 Laboratorios VPA10786/007/ 0.5 Oral solution - QP51AX08 POM: - Halofuginone Generic - Oral use mg/ml oral Karizoo S.A. 001 milligram(s)/millil Prescription Only application solution for itre Medicine as (Article 13(1) of calves defined in Directive No relevant national 2001/82/EC) legislation

HATCHPAK IB Boehringer VPA10454/061/ . Effervescent - QI01AD07 POM: - Live avian Full application - Nebulisation H120 NEO Ingelheim 001 tablet Prescription Only infectious (Article 12(3) of use effervescent Vetmedica Medicine as bronchitis virus Directive No tablet for GmbH defined in (strain h120) 2001/82/EC) nebuliser relevant national suspension for legislation chickens Hedylon 25 mg LIVISTO Int'l, VPA10425/009/ 25 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Generic - Oral use tablets for dogs S.L. 002 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Hedylon 5 mg LIVISTO Int'l, VPA10425/009/ 5 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Generic - Oral use tablets for dogs S.L. 001 Prescription Only application and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Helmex Cat 80 ZYLAVET VPA10407/002/ 80/20 mg/tablet Chewable/dispe - QP52AA51 CAM: - Pyrantel (as Generic - Oral use mg/20 mg Pharmaceuticals 001 rsible tablet Companion pyrantel application Chewable Ltd Animal Medicine embonate) (Article 13(1) of Tablets for Cats as defined in - Praziquantel Directive No relevant national 2001/82/EC) legislation

Helodip 3.1 % Bimeda Animal VPA22033/024/ 3.1 percent Teat dip - QD08AX LM: Licensed - Ammonium Full application - Topical use w/v Teat Dip Health Limited 001 weight/volume Merchant as lauryl sulphate (Article 12(3) of Concentrate defined in (as a Directive No relevant national concentrate 27- 2001/82/EC) legislation 28% w/w)

Veterinary Medicines Authorised/Transfer Pending Products Page 95 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration HEMOSILATE Ecuphar VPA10389/004/ 125 Solution for - QB02BX01 VPO: Veterinary - Etamsylate Generic - Intramuscular 125 mg/ml Veterinaria 001 milligram(s)/millil injection Practitioner Only application use Solution for S.L.U. itre as defined in (Article 13(1) of - Intravenous injection relevant national Directive No use legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 96 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Heptavac P Plus Intervet Ireland VPA10996/146/ . Suspension for - QI04AB05 LM: Licensed - Clostridium Full application - Subcutaneous Limited 001 injection Merchant as perfringens beta (Article 12(3) of use defined in toxoid (strains Directive No relevant national 554 and 578) 2001/82/EC) legislation - 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) Veterinary Medicines Authorised/Transfer Pending Products - Formalin Page 97 of 204 pasteurella trehalosi strain t15 (s1105/84) Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Hexaguard GEA Farm VPA10844/001/ 0.74 percent Teat dip - QD08AC02 LM: Licensed - Chlorhexidine ZZZ Complete - Topical use Technologies 001 weight/volume Merchant as digluconate application (UK) Ltd defined in (stand-alone) - relevant national Council Directive legislation 81/851/EEC

Hexasol LA Norbrook VPA22664/049/ 300,20 Solution for - QJ01AA56 POM: - Oxytetracycline Fixed - Intramuscular Solution for Laboratories 001 milligram(s)/millil injection Prescription Only dihydrate combination use Injection (Ireland) Limited itre Medicine as - Flunixin application defined in meglumine (Article 13b of relevant national Directive No legislation 2001/82/EC)

HIDROCOL, SP Veterinaria, VPA10790/009/ 4000000 Solution for use - QA07AA10 POM: - Colistin Hybrid - Oral use 4000000 IU/ml S.A. 001 international in drinking water, Prescription Only application solution for use unit(s)/millilitre Milk or milk Medicine as (Article 13(3) of in drinking replacer defined in Directive No water/milk relevant national 2001/82/EC) legislation

Hipra LHV Bonapp HOVR10466/00 Oral solution LM: Licensed - Solidago - Oral use 7/001 Merchant as - Euphrasia defined in officinalis relevant national - Echinacea legislation angustifolia - Allium cepa HIPRABOVIS Laboratorios VPA10846/005/ . Emulsion for - QI02AB POM: - Mannheimia Full application - Subcutaneous SOMNI/LktEmul Hipra S.A. 001 injection Prescription Only haemolytica (Article 12(3) of use sion for injection Medicine as biotype a, Directive No for cattle defined in serotype a1 2001/82/EC) relevant national leukotoxoid legislation - Haemophilus somnus bailie strain, inactivated HIPRABOVIS-4 Laboratorios VPA10846/003/ - percent Powder and - QI02AH POM: - Inactivated - Intramuscular Hipra S.A. 001 solvent for Prescription Only infectious bovine use suspension for Medicine as rhinotracheitis injection defined in virus strain LA relevant national - Inactivated legislation parainfluenza-3 virus, strain SF4 - Inactivated bovine diarrhoea virus strain NADL - Live bovine respiratory strain lym-56

HIPRACIN10 Laboratorios VPA10846/002/ 10 international Solution for - QH01BB02 POM: - Oxytocin Generic, hybrid - Intramuscular IU/ml Synthetic Hipra S.A. 001 unit(s)/millilitre injection Prescription Only or similar use Oxytocin, Medicine as biological - Intravenous solution for defined in application use injection relevant national (Article 13 of legislation Directive No 2001/82/EC) Hipracox Broilers Laboratorios VPA10846/009/ . Oral suspension - QI01AN01 POM: - Eimeria Full application - Oral use Oral suspension Hipra S.A. 001 Prescription Only acervulina, strain (Article 12(3) of for chicken Medicine as 003 Directive No defined in - Eimeria 2001/82/EC) relevant national maxima, strain legislation 013 - Eimeria mitis, strain 006 - Eimeria praecox, strain 007 - Eimeria tenella, strain 004

Veterinary Medicines Authorised/Transfer Pending Products Page 98 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Hipragumboro Laboratorios VPA10846/017/ . Lyophilisate for - QI01AD09 POM: - Avian infectious Full application - In drinking CW Lyophilisate Hipra S.A. 001 use in drinking Prescription Only bursal disease (Article 12(3) of water use for use in water Medicine as virus, live Directive No drinking water defined in 2001/82/EC) relevant national legislation

HIPRAGUMBO Laboratorios VPA10846/014/ . Lyophilisate for - QI01AD09 POM: - Live Infectious Full application - Oral use RO-G97 Hipra S.A. 001 suspension Prescription Only Bursal Disease (Article 12(3) of Medicine as Virus, strain Directive No defined in GM97 2001/82/EC) relevant national legislation

Histodine 10 Le Vet Beheer VPA10475/029/ 10 Solution for - QR06AB04 POM: - Generic - Intramuscular mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only Chlorphenamine application use for injection for itre Medicine as maleate (Article 13(1) of - Intravenous cattle defined in Directive No use relevant national 2001/82/EC) legislation

Hornex 42.7% Agri-Lloyd VPA22762/001/ 42.7 percent Cutaneous paste - QD11AX LM: Licensed - Sodium Generic - Cutaneous use w/w Cutaneous Limited 001 weight/weight Merchant as hydroxide application paste defined in (Article 13(1) of relevant national Directive No legislation 2001/82/EC)

Huvamox 800 Huvepharma NV VPA10782/038/ 800 Powder for use - QJ01CA04 POM: - Amoxicillin Hybrid - In drinking mg/g powder for 001 milligram(s)/gra in drinking water Prescription Only trihydrate application water use use in drinking m Medicine as (Article 13(3) of water for defined in Directive No chickens, relevant national 2001/82/EC) turkeys, ducks legislation and pigs HuveGuard Huvepharma NV VPA10782/027/ . Oral suspension - QI01AN POM: - Eimeria tenella Full application - Ocular use MMAT 001 Prescription Only - Eimeria mitis (Article 12(3) of - Oral use suspension for Medicine as - Eimeria Directive No oral suspension defined in maxima 2001/82/EC) for chickens relevant national - Eimeria legislation acervulina

HuveGuard NB Huvepharma NV VPA10782/025/ . Oral suspension - QI01AN01 POM: - Eimeria brunetti Full application - Oral use suspension for 001 Prescription Only strain roybru (Article 12(3) of oral suspension Medicine as 3+28 Directive No for chickens defined in - Eimeria 2001/82/EC) relevant national necatrix strain legislation mednec 3+8

HY-50 Vet. 17 Dechra VPA22622/010/ 17 Solution for - QM09AX01 POM: - Sodium Generic - Intraarticular mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Prescription Only hyaluronate application use for injection for itre Medicine as (Article 13(1) of - Intravenous horses defined in Directive No use relevant national 2001/82/EC) legislation

HydroDoxx 500 Huvepharma NV VPA10782/007/ 500 Powder for oral - QJ01AA02 POM: - Doxycycline Generic - Oral use mg/g Powder for 001 milligram(s)/gra solution Prescription Only application use in drinking m Medicine as (Article 13(1) of water for defined in Directive No chickens and relevant national 2001/82/EC) pigs legislation

Hymatil 300 Industrial VPA10509/001/ 300 Solution for - QJ01FA91 VPO: Veterinary - Tilmicosin Generic - Subcutaneous mg/ml solution Veterinaria, S.A. 001 milligram(s)/millil injection Practitioner Only application use for injection for itre as defined in (Article 13(1) of cattle and sheep relevant national Directive No legislation 2001/82/EC)

Hyogen Ceva Santé VPA10815/026/ . Emulsion for - QI09AB13 POM: - Inactivated Full application - Intramuscular emulsion for Animale 001 injection Prescription Only bacterin of (Article 12(3) of use injection for pigs Medicine as mycoplasma Directive No defined in hyopneumoniae 2001/82/EC) relevant national strain 2940 legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 99 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Hyonate 10 Boehringer VPA10454/062/ 10 Solution for - QM09AX01 VPO: Veterinary - Sodium - Intraarticular mg/ml solution Ingelheim 001 milligram(s)/millil injection Practitioner Only hyaluronate use for injection Vetmedica itre as defined in - Intravenous GmbH relevant national use legislation

HyperCard 10 Dechra VPA22622/011/ 10 mg/tablet Coated tablet - QC08DB01 POM: - Diltiazem - Oral use mg Coated Regulatory B.V. 001 Prescription Only hydrochloride Tablets for Cats Medicine as defined in relevant national legislation

Hypersol 500 HUVEPHARMA VPA10453/001/ 500 Oral powder - QJ01AA06 POM: - Oxytetracycline Generic - Oral use mg/g Powder for SA 001 milligram(s)/gra Prescription Only application use in Drinking m Medicine as (Article 13(1) of water defined in Directive No relevant national 2001/82/EC) legislation

Hypophysin LA Veyx-Pharma VPA10539/003/ 35 Solution for - QH01BB03 POM: - Carbetocin Hybrid - Intramuscular 35 microgram/ml GmbH 001 microgram(s)/mil injection Prescription Only application use solution for lilitre Medicine as (Article 13(3) of - Intravenous injection for defined in Directive No use cattle and pigs relevant national 2001/82/EC) legislation

Hypophysin LA Veyx-Pharma VPA10539/003/ 70 Solution for - QH01BB03 POM: - Carbetocin Hybrid - Intramuscular 70 microgram/ml GmbH 002 microgram(s)/mil injection Prescription Only application use solution for lilitre Medicine as (Article 13(3) of - Intravenous injection for defined in Directive No use cattle and pigs relevant national 2001/82/EC) legislation

Imaverol 100 AUDEVARD VPA10481/001/ 100 Cutaneous - QD01AC90 LM: Licensed - Enilconazole Full application - Topical use mg/ml 001 milligram(s)/millil emulsion Merchant as (Article 12(3) of Concentrate for itre defined in Directive No Cutaneous relevant national 2001/82/EC) Emulsion legislation

Imec 10 mg/ml ECO Animal VPA22693/007/ 10 Solution for - QP54AA01 POM: - Ivermectin Informed - Subcutaneous Solution for Health Europe 001 milligram(s)/millil injection Prescription Only consent use Injection Limited itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Imec 5 mg/ml ECO Animal VPA22693/005/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin - Topical use pour-on solution Health Europe 001 milligram(s)/millil Prescription Only for cattle Limited itre Medicine as defined in relevant national legislation

Imidacloprid Chanelle VPA10987/139/ 100 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use Chanelle 100 mg Pharmaceuticals 003 Prescription Only application Spot-on solution Manufacturing Medicine as (Article 13(3) of for Medium Dog Limited defined in Directive No relevant national 2001/82/EC) legislation

Imidacloprid Chanelle VPA10987/139/ 250 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use Chanelle 250 mg Pharmaceuticals 004 Prescription Only application Spot-on solution Manufacturing Medicine as (Article 13(3) of for Large Dogs Limited defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 100 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Imidacloprid Chanelle VPA10987/139/ 40 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use Chanelle 40 mg Pharmaceuticals 001 Prescription Only application Spot-on solution Manufacturing Medicine as (Article 13(3) of for Small Cats, Limited defined in Directive No Small Pet relevant national 2001/82/EC) Rabbits & Small legislation Dogs

Imidacloprid Chanelle VPA10987/139/ 400 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use Chanelle 400 mg Pharmaceuticals 005 Prescription Only application Spot-on solution Manufacturing Medicine as (Article 13(3) of for Extra Large Limited defined in Directive No Dogs relevant national 2001/82/EC) legislation

Imidacloprid Chanelle VPA10987/139/ 80 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use Chanelle 80 mg Pharmaceuticals 002 Prescription Only application Spot-on solution Manufacturing Medicine as (Article 13(3) of for Large Cats Limited defined in Directive No and Large Pet relevant national 2001/82/EC) Rabbits legislation

Imizol 85 mg/ml Intervet Ireland VPA10996/234/ 85 Solution for - QP51AE01 POM: - Imidocarb ZZZ Complete - Subcutaneous Solution for Limited 001 milligram(s)/millil injection Prescription Only diproprionate application use Injection itre Medicine as (stand-alone) - defined in Council Directive relevant national 81/851/EEC legislation

IMOCOLIBOV Boehringer VPA10454/063/ . Suspension for - QI02AC LM: Licensed - Inactivated Full application - Subcutaneous Ingelheim 001 injection - QI04AC Merchant as e.coli serotype (Article 12(3) of use Vetmedica defined in 09 Directive No GmbH relevant national - Inactivated 2001/82/EC) legislation e.coli serotype 08 - Inactivated e.coli serotype 015 - Inactivated e.coli serotype 078 - Inactivated e.coli serotype 0101 - Inactivated e.coli serotype 00117 - Inactivated e.coli (antigen k99) - Inactivated e.coli (antigen y) - Inactivated e.coli (antigen 31a)

Imoxicate 100 Krka, d.d., Novo VPA10774/067/ 100,25 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/25 mg spot- mesto 002 mg/pipette Prescription Only - Moxidectin application on solution for Medicine as (Article 13(3) of medium dogs defined in Directive No relevant national 2001/82/EC) legislation

Imoxicate 250 Krka, d.d., Novo VPA10774/067/ 250,62.5 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/62.5 mg mesto 003 mg/pipette Prescription Only - Moxidectin application spot-on solution Medicine as (Article 13(3) of for large dogs defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 101 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Imoxicate 40 Krka, d.d., Novo VPA10774/067/ 40,10 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/10 mg spot- mesto 001 Prescription Only - Moxidectin application on solution for Medicine as (Article 13(3) of small dogs defined in Directive No relevant national 2001/82/EC) legislation

Imoxicate 40 Krka, d.d., Novo VPA10774/065/ 40,4 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/4 mg spot-on mesto 001 Prescription Only - Moxidectin application solution for small Medicine as (Article 13(3) of cats and ferrets defined in Directive No relevant national 2001/82/EC) legislation

Imoxicate 400 Krka, d.d., Novo VPA10774/067/ 400,100 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/100 mg spot- mesto 004 mg/pipette Prescription Only - Moxidectin application on solution for Medicine as (Article 13(3) of extra-large dogs defined in Directive No relevant national 2001/82/EC) legislation

Imoxicate 80 Krka, d.d., Novo VPA10774/066/ 80,8 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/8 mg spot-on mesto 001 Prescription Only - Moxidectin application solution for large Medicine as (Article 13(3) of cats defined in Directive No relevant national 2001/82/EC) legislation

INDUPART 75 Vetpharma VPA10516/010/ 75 Solution for - QG02AD90 POM: - D-cloprostenol Generic - Intramuscular micrograms /mL Animal Health, 001 microgram(s)/mil injection Prescription Only application use solution for S.L. lilitre Medicine as (Article 13(1) of injection for defined in Directive No cattle, pigs and relevant national 2001/82/EC) horses legislation

Ingelvac Boehringer VPA10454/007/ . Suspension for - QI09AB13 LM: Licensed - Inactivated Full application - Intramuscular MycoFLEX Ingelheim 001 injection Merchant as mycoplasma (Article 12(3) of use suspension for Vetmedica defined in hyopneumoniae, Directive No injection for pigs GmbH relevant national j strain isolate b- 2001/82/EC) legislation 3745

Ingelvac Boehringer VPA10454/008/ 10^{4.4 Lyophilisate and - QI09AD03 POM: - Attenuated prrs Full application - Intramuscular PRRSFLEX EU Ingelheim 001} - solvent for Prescription Only 94881 virus (Article 12(3) of use lyophilisate and Vetmedica 10^{6.6 tissue culture injection defined in 2001/82/EC) suspension for infective dose relevant national injection for pigs 50% / 1 millilitre legislation}

INMEVA, Laboratorios VPA10846/018/ . Suspension for - QI04AB POM: - Chlamydophila Full application - Subcutaneous suspension for Hipra S.A. 001 injection Prescription Only abortus strain (Article 12(3) of use injection Medicine as A22 inactivated Directive No defined in - Salmonella 2001/82/EC) relevant national enterica subsp. legislation enterica serovar Abortusovis strain Sao

Insecinor 10 Norbrook VPA22664/119/ 10 Spot-on solution - QP53AC11 POM: - Deltamethrin Generic - Topical use mg/ml Spot-on Laboratories 001 milligram(s)/millil Prescription Only application Solution for (Ireland) Limited itre Medicine as (Article 13(1) of cattle and sheep defined in Directive No relevant national 2001/82/EC) legislation

Insistor 10 mg/ml Richter Pharma VPA10801/012/ 10 Solution for - QN02AC90 VPO: Veterinary - Methadone Generic - Intramuscular solution for AG 001 milligram(s)/millil injection Practitioner Only hydrochloride application use injection for dogs itre as defined in (Article 13(1) of - Intravenous and cats relevant national Directive No use legislation 2001/82/EC) - Subcutaneous use

Veterinary Medicines Authorised/Transfer Pending Products Page 102 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Interclox DC Chem-Pharm VPA10823/011/ 500, 250
Intramammary - QJ51RC POM: - Ampicillin Informed - Intramammary Intramammary 001 mg/syringe suspension Prescription Only - Cloxacillin consent use Suspension Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Interject 15% Interchem VPA10555/006/ 15 percent Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular Injection Ireland Ltd 001 weight/volume injection Prescription Only hydrochloride consent use Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Intertrim Chem-Pharm VPA10823/005/ 40, 200
Solution for - QJ01EW10 POM: - Trimethoprim Informed - Intramuscular 001 milligram(s)/millil injection Prescription Only - Sulfadiazine consent use itre Medicine as application - Intravenous defined in (Article 13c of use relevant national Directive No - Subcutaneous legislation 2001/82/EC) use

INTRA Intracare B.V. VPA10409/001/ 499 Solution for use - QA07XA POM: - Zinc disodium Full application - In drinking DYSOVINOL 001 milligram(s)/millil in drinking water Prescription Only EDTA (Article 12(3) of water use 499 mg/ml itre Medicine as Directive No solution for use defined in 2001/82/EC) in drinking water relevant national for pigs legislation

Intra-Epicaine 20 Dechra VPA22622/013/ 20 Solution for - QN01BB03 VPO: Veterinary - Mepivacaine Well-established - Epidural use mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride use application - Intraarticular for injection for itre as defined in (Article 13a of use horses relevant national Directive No - Intrabursal use legislation 2001/82/EC) - Perineural use

Intubeaze 20 Dechra VPA22622/014/ 20 laryngopharyng - QR02AD02 VPO: Veterinary - Lidocaine Generic - mg/ml Regulatory B.V. 001 milligram(s)/millil eal spray, Practitioner Only Hydrochloride application Laryngopharyng laryngopharyng itre solution as defined in Monohydrate (Article 13(1) of eal use eal spray, relevant national Directive No solution for cats legislation 2001/82/EC)

Ioguard Ready to GEA Farm VPA10844/003/ 0.5 percent Teat dip/spray - QD08AG03 LM: Licensed - Available iodine ZZZ Complete - Topical use Use Teat Dip Technologies 001 weight/volume solution Merchant as application (UK) Ltd defined in (stand-alone) - relevant national Council Directive legislation 81/851/EEC

Ioguard GEA Farm VPA10844/002/ 2.5 percent Teat dip/spray - QD08AG03 LM: Licensed - Available iodine ZZZ Complete - Topical use Superconcentrat Technologies 001 weight/volume solution Merchant as application e (UK) Ltd defined in (stand-alone) - relevant national Council Directive legislation 81/851/EEC

Isaderm 5 mg/g Dechra VPA10803/006/ 5, 1 Gel - QD07CC01 POM: - Fusidic acid Generic - Cutaneous use + 1 mg/g gel for Veterinary 001 milligram(s)/gra Prescription Only - Betamethasone application dogs Products A/S m Medicine as valerate (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Isathal 10 mg/g Dechra VPA10803/004/ 10 Eye drops, - QS01AA13 POM: - Fusidic acid ZZZ --Unknown- - Ocular use eye drops, Veterinary 001 milligram(s)/gra suspension Prescription Only suspension for Products A/S m Medicine as dogs, cats and defined in rabbits relevant national legislation

Iso - Vet 1000 Piramal Critical VPA22583/001/ 1000 Inhalation - QN01AB06 VPO: Veterinary - Isoflurane Generic - Inhalation use mg/g Inhalation Care B.V. 001 milligram(s)/gra vapour, liquid Practitioner Only application Vapour, liquid m as defined in (Article 13(1) of relevant national Directive No legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 103 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration ISOFLURIN Vetpharma VPA10516/012/ 1000 Inhalation - QN01AB06 VPO: Veterinary - Isoflurane Generic - Inhalation use 1000 mg/g Animal Health, 001 milligram(s)/gra vapour, liquid Practitioner Only application Inhalation S.L. m as defined in (Article 13(1) of Vapour, Liquid relevant national Directive No legislation 2001/82/EC)

Isothesia 1000 Piramal Critical VPA22583/002/ 1000 Inhalation - QN01AB06 VPO: Veterinary - Isoflurane Generic - Inhalation use mg/g inhalation Care B.V. 001 milligram(s)/gra vapour, liquid Practitioner Only application vapour, liquid m as defined in (Article 13(1) of relevant national Directive No legislation 2001/82/EC)

Itrafungol 10 Virbac S.A. VPA10988/116/ 10 Oral solution - QJ02AC02 POM: - Itraconazole Full application - Oral use mg/ml Oral 001 milligram(s)/millil Prescription Only (Article 12(3) of Solution itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Iverpraz, 18.7 Norbrook VPA22664/148/ 18.7, 140.3 Oral paste - QP54AA51 POM: - Ivermectin Hybrid - Oral use mg/g + 140.3 Laboratories 001 milligram(s)/gra Prescription Only - Praziquantel application mg/g Oral Paste (Ireland) Limited m Medicine as (Article 13(3) of for Horses defined in Directive No relevant national 2001/82/EC) legislation

Ivomec Classic Boehringer VPA10454/064/ 10 Solution for - QP54AA01 POM: - Ivermectin Full application - Subcutaneous Injection for Ingelheim 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use Cattle and Vetmedica itre Medicine as Directive No Sheep 10 mg/ml GmbH defined in 2001/82/EC) relevant national legislation

Ivomec Classic Boehringer VPA10454/065/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin Full application - Topical use Pour-On for Ingelheim 001 milligram(s)/millil Prescription Only (Article 12(3) of Cattle 5 mg/ml Vetmedica itre Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

Ivomec Super Boehringer VPA10454/068/ 10, 100 Solution for - QP54AA51 POM: - Ivermectin Fixed - Subcutaneous Injection for Ingelheim 001 milligram(s)/millil injection Prescription Only - Clorsulon combination use Cattle Vetmedica itre Medicine as application GmbH defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Kabergovet 50 Vet-Agro Multi- VPA20742/007/ 50 Oral solution - QG02CB03 POM: - Cabergoline Generic - Oral use microgram/ml Trade Company 001 microgram(s)/mil Prescription Only application oral solution for Sp z o.o. lilitre Medicine as (Article 13(1) of dogs and cats defined in Directive No relevant national 2001/82/EC) legislation

Kali Sulphuricum Galway HOVR10537/01 200 c Oral solution LM: Licensed - Kali - Oral use 200c Homoeopathics 1/001 Merchant as sulphuricum (Manufacturing) defined in Limited relevant national legislation

Kanacef M.C. Interchem VPA10555/001/ . Intramammary - QJ51RD01 POM: - Kanamycin Informed - Intramammary Intramammary Ireland Ltd 001 suspension Prescription Only monosulfate consent use Suspension Medicine as - Cefalexin application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

KARIFLOX 100 Laboratorios VPA10786/002/ 100 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml Oral Karizoo S.A. 001 milligram(s)/millil Prescription Only application Solution for itre Medicine as (Article 13(1) of Chickens and defined in Directive No Turkeys relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 104 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration KARIFLOX 25 Laboratorios VPA10786/004/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml oral Karizoo S.A. 001 milligram(s)/millil Prescription Only application solution for itre Medicine as (Article 13(1) of calves defined in Directive No relevant national 2001/82/EC) legislation

KARIFLOX 5 Laboratorios VPA10786/003/ 5 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml oral Karizoo S.A. 001 milligram(s)/millil Prescription Only application solution for itre Medicine as (Article 13(1) of piglets defined in Directive No relevant national 2001/82/EC) legislation

Keelogane SC Bimeda Animal VPA22033/025/ 25 Oral suspension - QP52AC11 POM: - Albendazole Informed - Oral use 25 mg/ml Oral Health Limited 001 milligram(s)/millil Prescription Only consent suspension itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

KEFAMAST Dry Bimeda Animal VPA22033/041/ 500/500 Intramammary - QJ51RD01 POM: - Cefalexin ZZZ Informed - Intramammary Cow Health Limited 001 mg/syringe suspension Prescription Only - consent use Intramammary Medicine as Dihydrostreptom (abridged Suspension defined in ycin sulfate application) - relevant national Council Directive legislation 81/851/EEC

Kefloril 300 Vetoquinol VPA10983/053/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular mg/ml Solution Ireland Limited 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle and pigs defined in Directive No use relevant national 2001/82/EC) legislation

Kelacyl 100 Kela n.v. VPA10981/014/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular mg/ml, solution 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Kelaprofen 100 Kela n.v. VPA10981/012/ 100 Solution for - QM01AE03 POM: - Ketoprofen Generic - Intramuscular mg/ml, solution 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, horses defined in Directive No use and pigs relevant national 2001/82/EC) legislation

Kelevo 200 µg LIVISTO Int'l, VPA10425/018/ 200 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Generic - Oral use tablets for dogs S.L. 001 Prescription Only sodium application and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Kelevo 400 µg LIVISTO Int'l, VPA10425/018/ 400 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Hybrid - Oral use tablets for dogs S.L. 002 Prescription Only sodium application and cats Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Kelevo 800 µg LIVISTO Int'l, VPA10425/018/ 800 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Hybrid - Oral use tablets for dogs S.L. 003 Prescription Only sodium application Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Kenocidin CID LINES N.V. VPA10792/003/ 5 Liquid - QD08AC02 LM: Licensed - Chlorhexidine Full application - Topical use Chlorhexidine 001 milligram(s)/millil Merchant as digluconate (Article 12(3) of digluconate 5 itre defined in Directive No mg/ml, Teat dip relevant national 2001/82/EC) solution for cattle legislation (dairy)

Veterinary Medicines Authorised/Transfer Pending Products Page 105 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Kenocidin CID LINES N.V. VPA10792/004/ 5 Teat dip/spray - QD08AC02 LM: Licensed - Chlorhexidine Full application - Topical use SPRAY AND 001 milligram(s)/millil solution Merchant as digluconate (Article 12(3) of DIPChlorhexidin itre defined in Directive No e digluconate 5 relevant national 2001/82/EC) mg/ml, Teat Dip / legislation Teat Spray solution for cattle (dairy) Kenostart 3 mg/g CID LINES N.V. VPA10792/001/ 3 Teat dip - QD08AG03 LM: Licensed - Available iodine Full application - Topical use teat dip solution 001 milligram(s)/gra Merchant as (Article 12(3) of for cattle (dairy). m defined in Directive No relevant national 2001/82/EC) legislation

KENOSTART CID LINES N.V. VPA10792/002/ 3 Teat dip - QD08AG03 LM: Licensed - Available iodine Full application - Topical use SPRAY AND 001 milligram(s)/gra Merchant as (Article 12(3) of DIP 3 mg/g Teat m defined in Directive No Dip or Spray relevant national 2001/82/EC) Solution for legislation cattle (dairy) Kesium 200 mg / Ceva Santé VPA10815/034/ 250 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use 50 mg Chewable Animale 003 Prescription Only - Clavulanic acid application tablets for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Kesium 40 mg / Ceva Santé VPA10815/034/ 50 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use 10 mg Chewable Animale 001 Prescription Only - Clavulanic acid application tablets for cats Medicine as (Article 13(1) of and dogs defined in Directive No relevant national 2001/82/EC) legislation

Kesium 400 mg / Ceva Santé VPA10815/034/ 500 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use 100 mg Animale 004 Prescription Only - Clavulanic acid application Chewable tablets Medicine as (Article 13(1) of for dogs defined in Directive No relevant national 2001/82/EC) legislation

Kesium 50 mg / Ceva Santé VPA10815/034/ 62.5 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use 12.5 mg Animale 002 Prescription Only - Clavulanic acid application Chewable tablets Medicine as (Article 13(1) of for cats and dog defined in Directive No relevant national 2001/82/EC) legislation

Kesium 500 mg / Ceva Santé VPA10815/034/ 625 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use 125 mg Animale 005 Prescription Only - Clavulanic acid application Chewable tablets Medicine as (Article 13(1) of for dogs defined in Directive No relevant national 2001/82/EC) legislation

Ketabel 100 Bela-Pharm VPA10445/005/ 10 percent Solution for - QN01AX03 VPO: Veterinary - Ketamine Generic - Intramuscular mg/ml solution GmbH & Co. KG 001 injection Practitioner Only hydrochloride application use for injection as defined in (Article 13(1) of - Intraperitoneal relevant national Directive No use legislation 2001/82/EC) - Intravenous use

Ketamidor 100 Richter Pharma VPA10801/006/ 100 Solution for - QN01AX03 VPO: Veterinary - Ketamine Hybrid - Intramuscular mg/ml solution AG 001 milligram(s)/millil injection Practitioner Only application use for injection itre as defined in (Article 13(3) of - Intravenous relevant national Directive No use legislation 2001/82/EC) - Subcutaneous use

Ketavet 100 Zoetis Belgium VPA10387/036/ 100 Solution for - QN01AX03 VPO: Veterinary - Ketamine Generic - Intramuscular mg/ml solution S.A. 001 milligram(s)/millil injection Practitioner Only application use for injection for itre as defined in (Article 13(1) of - Intravenous dogs, cats and relevant national Directive No use horses legislation 2001/82/EC) - Subcutaneous use

Veterinary Medicines Authorised/Transfer Pending Products Page 106 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Ketink 100 Industrial VPA10509/002/ 100 Solution for - QM01AE03 POM: - Ketoprofen Generic - Intramuscular mg/ml solution Veterinaria, S.A. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, horses defined in Directive No use and pigs relevant national 2001/82/EC) legislation

Ketodolor 100 Le Vet Beheer VPA10475/008/ 100 Solution for - QM01AE03 POM: - Ketoprofen Generic - Intramuscular mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous horses, cattle, defined in Directive No use pigs relevant national 2001/82/EC) legislation

Ketofen 10 % Ceva Santé VPA10815/051/ 10 percent Solution for - QM01AE03 POM: - Ketoprofen - Intramuscular Solution for Animale 001 weight/volume injection Prescription Only use Injection Medicine as - Intravenous defined in use relevant national legislation

KEYTIL 300 Vetpharma VPA10516/019/ 300, 90 Solution for - QJ01FA99 VPO-1: - Tilmicosin Fixed - Subcutaneous mg/ml + 90 Animal Health, 001 milligram(s)/millil injection Veterinary - Ketoprofen combination use mg/ml solution S.L. itre Practitioner Only application for injection as defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Kilo-mec 0.5 % ECO Animal VPA22693/018/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin Informed - Topical use Pour-On Solution Health Europe 001 Prescription Only consent for Cattle Limited Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Kilo-mec 1% ECO Animal VPA22693/020/ 1 percent Solution for - QP54AA01 POM: - Ivermectin Informed - Subcutaneous Solution for Health Europe 001 weight/volume injection Prescription Only consent use Injection Limited Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Lactatrim MC Norbrook VPA22664/042/ 40, 200 Intramammary - QJ51E POM: - Trimethoprim Fixed - Intramammary Lactating Cow Laboratories 001 mg/syringe suspension Prescription Only - Sulphadiazine combination use Intramammary (Ireland) Limited Medicine as application Suspension. defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Lactovac Zoetis Belgium VPA10387/037/ strain Suspension for - QI02AL01 LM: Licensed - Inactivated Full application - Subcutaneous Suspension for S.A. 001 1005/78  injection Merchant as bovine rotavirus, (Article 12(3) of use injection at least 107.4 defined in strain 1005/78 Directive No relevant national - Inactivated 2001/82/EC) legislation bovine rotavirus, strain holland - Inactivated bovine coronavirus, strain 800 - Inactivated e.coli k99/f41, strain s1091/83

LANFLOX 100 Vetpharma VPA10516/004/ 100 Solution for use - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml Solution Animal Health, 001 milligram(s)/millil in drinking water Prescription Only application for use in S.L. itre Medicine as (Article 13(1) of drinking water for defined in Directive No Chickens and relevant national 2001/82/EC) Turkeys legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 107 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Lanodip Kilco VPA10948/001/ 26.7 Teat dip/spray - QD08AG03 LM: Licensed - Iodine Well-established - Topical use Concentrate (International) 002 milligram(s)/millil solution Merchant as use application Teat Dip 3:1 Ltd. itre defined in (Article 13a of relevant national Directive No legislation 2001/82/EC)

Lanodip Kilco VPA10948/001/ 33.37 Teat dip/spray - QD08AG LM: Licensed - Iodine Well-established - Topical use Concentrate (International) 003 milligram(s)/millil solution Merchant as use application Teat Dip 4:1 Ltd. itre defined in (Article 13a of relevant national Directive No legislation 2001/82/EC)

Lanodip Kilco VPA10948/001/ 20 Teat dip solution - QD08AG LM: Licensed - Iodine - Topical use Concentrate (International) 001 milligram(s)/millil Merchant as Teat Dip Solution Ltd. itre defined in 2:1 relevant national legislation

Lanodip Ready Kilco VPA10948/001/ 6.7 Teat dip/spray - QD08AG03 LM: Licensed - Iodine Well-established - Topical use To Use Teat Dip (International) 004 milligram(s)/millil solution Merchant as use application Ltd. itre defined in (Article 13a of relevant national Directive No legislation 2001/82/EC)

Lapseli LHV Bonapp HOVR10466/00 . Oral solution LM: Licensed - Silica (colloidal, Simplified - Oral use 9/001 Merchant as anhydrous) Registration of a defined in - Carbo Veterinary relevant national vegetabilis Homeopathic legislation - Solidago Medicinal virgaurea Product (Article - Phytolacca 16, Directive decandra 2001/82/EC) - Thuja occidentalis - Calendula officinalis - Atropa belladonna

Larocop 20 Chanelle VPA10987/025/ 20 Suspension for - QA12CX LM: Licensed - Copper - Intramuscular mg/ml Pharmaceuticals 001 milligram(s)/millil injection Merchant as use Suspension for Manufacturing itre defined in injection Limited relevant national legislation

Laurabolin 25 Intervet Ireland VPA10996/002/ 25 Solution for - QA14AB01 POM: - Nandrolone Full application - Intramuscular mg/ml solution Limited 001 milligram(s)/millil injection Prescription Only laurate (Article 12(3) of use for injection itre Medicine as Directive No - Subcutaneous defined in 2001/82/EC) use relevant national legislation

Laxatract Le Vet Beheer VPA10475/041/ 667 Syrup - QA06AD11 POM: - Lactulose, Generic - Oral use 667mg/ml syrup B.V. 001 milligram(s)/millil Prescription Only liquid application for dogs and cat itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

LECTADE Plus Elanco GmbH VPA22020/030/ . Powder for oral - QA07CQ02 LM: Licensed - Sodium - Oral use Powder for Oral 001 solution Merchant as chloride Solution defined in - Glycine relevant national - Potassium legislation dihydrogen phosphate - Sodium acid citrate - Potassium citrate - Sodium citrate - Glucose monohydrate

Veterinary Medicines Authorised/Transfer Pending Products Page 108 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Leptavoid-H Intervet Ireland VPA10996/235/ . Suspension for - QI02AB03 LM: Licensed - Leptospira Full application - Subcutaneous Suspension for Limited 001 injection Merchant as interrogans (Article 12(3) of use injection for defined in serovar hardjo Directive No cattle relevant national 204 (inactivated) 2001/82/EC) legislation

Leucogen Virbac S.A. VPA10988/040/

.

injection Prescription Only virus envelope consent use Medicine as antigen p45 application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Levacide 1.5 Norbrook VPA22664/027/ 1.5 percent Oral solution - QP52AE51 LM: Licensed - Levamisole - Oral use %w/v SC Worm Laboratories 001 weight/volume Merchant as hydrochloride Drench (Ireland) Limited defined in relevant national legislation

Levacide Norbrook VPA22664/025/ 75 Solution for - QP52AE01 POM: - Levamisole Full application - Subcutaneous Injection 75 Laboratories 001 milligram(s)/millil injection Prescription Only hydrochloride (Article 12(3) of use mg/ml (Ireland) Limited itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Levacide Low Norbrook VPA22664/026/ 75 Oral solution - QP52AE01 POM: - Levamisole - Oral use Volume Worm Laboratories 001 milligram(s)/millil Prescription Only hydrochloride Drench 75 mg/m (Ireland) Limited itre Medicine as defined in relevant national legislation

Levacide Pour- Norbrook VPA22664/047/ 200 Pour-on solution - QP52AE01 LM: Licensed - Levamisole - Topical use on 200 mg/ml Laboratories 001 milligram(s)/millil Merchant as hydrochloride (Ireland) Limited itre defined in relevant national legislation

Levafas Norbrook VPA22664/024/ 3, 6 percent Oral suspension - QP52AE51 POM: - Levamisole - Oral use Diamond Fluke Laboratories 001 weight/volume Prescription Only hydrochloride and Worm (Ireland) Limited Medicine as - Oxyclozanide Drench defined in relevant national legislation

Levafluke Oral Biochem Ltd VPA10926/008/ 15,22.5 Oral suspension - QP52AE51 POM: - Levamisole Informed - Oral use Drench 001 milligram(s)/millil Prescription Only hydrochloride consent itre Medicine as - Rafoxanide application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Levapharm Chem-Pharm VPA10823/010/ 75 Solution for - QP52AE01 POM: - Levamisole Informed - Subcutaneous Injection 75 001 milligram(s)/millil injection Prescription Only consent use mg/ml itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Leventa 1 mg/ml Intervet Ireland VPA10996/199/ 1 Oral solution - QH03AA01 POM: - Levothyroxine Well-established - Oral use oral solution for Limited 001 milligram(s)/millil Prescription Only sodium use application dogs itre Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Levicare Hi- Ancare Ireland VPA10915/004/ 3.75 percent Oral solution - QP52AE01 POM: - Levamisole - Oral use Mineral Oral Ltd. 001 weight/volume Prescription Only hydrochloride Solution Medicine as defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 109 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Libeo 10 mg Ceva Santé VPA10815/037/ 10 mg/tablet Chewable tablet - QC03CA01 POM: - Furosemide Generic - Oral use chewable tablets Animale 001 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Libeo 40 mg Ceva Santé VPA10815/037/ 40 mg/tablet Chewable tablet - QC03CA01 POM: - Furosemide Generic - Oral use chewable tablets Animale 002 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Libromide 325 Dechra VPA22622/015/ 325 mg/tablet Tablet - QN05CM11 POM: - Potassium Full application - Oral use mg tablets for Regulatory B.V. 001 Prescription Only bromide (Article 12(3) of dogs Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Liceban 2.5% Bimeda Animal VPA22033/026/ 2.5 percent Pour-on solution - QP53AC08 POM: - Cypermethrin Informed - Topical use w/v Pour on Health Limited 001 weight/volume Prescription Only technical (93%) consent Solution Medicine as (cis: trans 50:50) application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

LidoBel 20 Bela-Pharm VPA10445/004/ 20 Solution for - QN01BB02 VPO: Veterinary - Lidocaine Generic - Intramuscular mg/ml solution GmbH & Co. KG 001 milligram(s)/millil injection Practitioner Only hydrochloride ph. application use for injection for itre as defined in eur. (Article 13(1) of - Perineural use horses, dogs, relevant national Directive No - Subcutaneous and cats. legislation 2001/82/EC) use - Submucosal use Lignocaine Chem-Pharm VPA10823/019/ 20, 0.027
Solution for - QN01BB52 VPO: Veterinary - Lidocaine Informed - Intramuscular Adrenaline 001 milligram(s)/millil injection Practitioner Only hydrochloride consent use Solution for itre as defined in - Epinephrine application - Perineural use Injection relevant national acid tartrate (Article 13c of - Subcutaneous legislation Directive No use 2001/82/EC)

Lincocin Soluble Zoetis Belgium VPA10387/038/ 400 Powder for use - QJ01FF02 POM: - Lincomycin Full application - Oral use Powder, 400 S.A. 001 milligram(s)/gra in drinking water Prescription Only hydrochloride (Article 12(3) of mg/g powder for m Medicine as Directive No use in drinking defined in 2001/82/EC) water relevant national legislation

Lincocin Sterile Zoetis Belgium VPA10387/039/ 100 Solution for - QJ01FF02 POM: - Lincomycin Full application - Intramuscular Solution S.A. 001 milligram(s)/millil injection Prescription Only hydrochloride (Article 12(3) of use itre Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national legislation

Linco-Spectin Zoetis Belgium VPA10387/040/ 222, 444.7 Powder for use - QJ01FF52 POM: - Spectinomycin Full application - Oral use 100, 222/444.7 S.A. 001 milligram(s)/gra in drinking water Prescription Only - Lincomycin (Article 12(3) of mg/g Powder for m Medicine as Directive No use in drinking defined in 2001/82/EC) water for pigs relevant national and chickens legislation

Linco-Spectin Kernfarm BV PVPA22031/001 222, 444.7 Powder for oral - QJ01FF52 POM: - Lincomycin - Oral use 100, 222/444.7 /001 milligram(s)/gra solution Prescription Only - Spectinomycin mg/g Powder for m Medicine as use in drinking defined in water for pigs relevant national and chickens legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 110 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Linco-Spectin Zoetis Belgium VPA10387/041/ 50,100 Solution for - QJ01FF52 POM: - Lincomycin - Intramuscular Sterile Solution S.A. 001 milligram(s)/millil injection Prescription Only hydrochloride use itre Medicine as - Spectinomycin defined in Sulfate relevant national legislation

Linspec 50/100 Chanelle VPA10987/079/ 50, 100 Solution for - QJ01FF52 POM: - Lincomycin Generic - Intramuscular mg/ml Solution Pharmaceuticals 001 milligram(s)/millil injection Prescription Only hydrochloride application use for injection for Manufacturing itre Medicine as - Spectinomycin (Article 13(1) of dogs, cats, pigs Limited defined in Sulfate Directive No and pre-ruminant relevant national Tetrahydrate 2001/82/EC) calves legislation

Liquid Life Aid Norbrook VPA22664/023/ . Oral solution - QA07CQ02 LM: Licensed - Glucose - Oral use Concentrate for Laboratories 001 milligram(s)/millil Merchant as monohydrate Oral Solution for (Ireland) Limited itre defined in - Sodium Cattle, Pigs and relevant national chloride Sheep legislation - Sodium propionate - Potassium dihydrogen orthophosphate - Glycine Lismay 444.7 Laboratorios VPA10436/004/ 444.7,222.0 Powder for use - QJ01FF52 POM: - Spectinomycin Generic - In drinking mg/g + 222.0 Maymó, S.A. 001 milligram(s)/gra in drinking water Prescription Only - Lincomycin application water use mg/g powder for m Medicine as (Article 13(1) of use in drinking defined in Directive No water for pigs relevant national 2001/82/EC) legislation

Lodisure 1 mg Dechra VPA22622/032/ 1 milligram(s) Tablet - QC08CA01 POM: - Amlodipine Full application - Oral use tablets for cats Regulatory B.V. 001 Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Longocilline 150 Ceva Santé VPA10815/023/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin Generic - Intramuscular mg/ml Animale 001 milligram(s)/millil injection Prescription Only application use suspension for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle and pigs relevant national 2001/82/EC) legislation

Lutalyse Zoetis Belgium VPA10387/042/ 5 Solution for - QG02AD01 POM: - Dinoprost - Intramuscular S.A. 001 milligram(s)/millil injection Prescription Only trometamol use itre Medicine as defined in relevant national legislation

Lutalyse High Zoetis Belgium VPA10387/042/ 12.5 Solution for - QG02AD01 POM: - Dinoprost Full application - Intramuscular Concentration S.A. 002 milligram(s)/millil injection Prescription Only trometamol (Article 12(3) of use 12.5 mg/ml itre Medicine as Directive No solution for defined in 2001/82/EC) injection for relevant national cattle legislation

M+PAC Intervet Ireland VPA10996/236/ 1.47-4.24 Emulsion for - QI09AB13 POM: - Inactivated Full application - Intramuscular Limited 001 Relative potency injection Prescription Only mycoplasma (Article 12(3) of use Medicine as hyopneumoniae Directive No defined in 2001/82/EC) relevant national legislation

Macromectin Norbrook VPA22664/076/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin Generic - Topical use 0.5% w/v Pour- Laboratories 001 weight/volume Prescription Only application On Solution (Ireland) Limited Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 111 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Macromectin 0.8 Norbrook VPA22664/075/ 0.8 Oral solution - QP54AA01 POM: - Ivermectin - Oral use mg/ml oral Laboratories 001 milligram(s)/millil Prescription Only solution for (Ireland) Limited itre Medicine as sheep defined in relevant national legislation

Macrosyn 100 Bimeda Animal VPA22033/073/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular mg/ml solution Health Limited 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle, pigs and defined in Directive No use sheep relevant national 2001/82/EC) legislation

Magnesium Chem-Pharm VPA10823/016/ 25 percent Solution for - QA12CC02 LM: Licensed - Magnesium Informed - Subcutaneous Sulphate 25 % 001 weight/volume injection Merchant as sulphate consent use Solution for defined in application Injection relevant national (Article 13c of legislation Directive No 2001/82/EC) Magnesium Chanelle VPA10987/037/ 25 percent Solution for - QA12CC02 LM: Licensed - Magnesium - Intravenous Sulphate 25% Pharmaceuticals 001 weight/volume injection Merchant as sulphate use Solution for Manufacturing defined in heptahydrate - Subcutaneous Injection Limited relevant national use legislation

Magniject 25% Norbrook VPA22664/030/ 25 percent Solution for - QA12CC02 LM: Licensed - Magnesium - Subcutaneous Solution for Laboratories 001 weight/volume injection Merchant as sulphate use Injection (Ireland) Limited defined in heptahydrate relevant national legislation

Malaseb Dechra VPA10803/005/ 20 Shampoo - QD08AC52 POM: - Chlorhexidine Generic - Topical use shampoo for Veterinary 001 milligram(s)/millil Prescription Only digluconate application dogs and cats Products A/S itre Medicine as - Miconazole (Article 13(1) of defined in nitrate Directive No relevant national 2001/82/EC) legislation

Mamyzin 269.5 Boehringer VPA10454/009/ 269.5 Powder and - QJ01CE90 POM: - Penethamate Known active - Intramuscular mg/ml Powder Ingelheim 001 milligram(s)/millil solvent for Prescription Only hydriodide substance use and Solvent for Vetmedica itre suspension for Medicine as (Article 12(3) of Suspension for GmbH injection defined in Directive No Injection for relevant national 2001/82/EC) cattle legislation

Maprelin 75 Veyx-Pharma VPA10539/001/ 75 Solution for - QH01CA POM: - Peforelin Full application - Intramuscular microgram/ml GmbH 001 microgram(s)/mil injection Prescription Only (Article 12(3) of use solution for lilitre Medicine as Directive No injection for pigs defined in 2001/82/EC) relevant national legislation

MAQS Formic NOD Apiary VPA22670/001/ 68.2 Bee-hive strip - QP53AG01 LM: Licensed - Formic acid Full application - Cutaneous use Acid 68.2g Ireland Ltd 001 gram(s)/strip Merchant as (Article 12(3) of Beehive Strips defined in Directive No for Honey Bees relevant national 2001/82/EC) legislation

Maracycline 500 Univet Limited VPA10990/029/ 500 Premix for - QJ01AA06 POM: - Oxytetracycline ZZZ Complete - Oral use mg/g Premix for 001 milligram(s)/gra medicated Prescription Only hydrochloride application Medicated m feeding stuff Medicine as (stand-alone) - Feeding defined in Council Directive relevant national 81/851/EEC legislation

Maracycline Univet Limited VPA10990/031/ 100 percent Premix for - QJ01AA06 POM: - Oxytetracycline - Oral use Powder 100 % 001 weight/weight medicated Prescription Only hydrochloride w/w Premix for feeding stuff Medicine as Medicated Feed defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 112 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Marbim 100 Bimeda Animal VPA22033/062/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only application use for Injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Marbocare Emdoka bvba VPA10534/004/ 20 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use flavour 20 mg 002 Prescription Only application tablets for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Marbocare Emdoka bvba VPA10534/004/ 5 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use flavour 5 mg 001 Prescription Only application tablets for dogs Medicine as (Article 13(1) of and cats defined in Directive No relevant national 2001/82/EC) legislation

Marbocare Emdoka bvba VPA10534/004/ 80 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use flavour 80 mg 003 Prescription Only application tablets for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

MARBOCYL 1% Vetoquinol VPA10983/037/ 1 percent Powder and - QJ01MA93 POM: - Marbofloxacin - Intravenous SA, powder and Ireland Limited 001 weight/volume solvent for Prescription Only use solvent for solution for Medicine as - Subcutaneous solution for injection defined in use injection, for cats relevant national and dogs legislation

Marbocyl 10 % Vetoquinol VPA10983/034/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin - Intramuscular Solution for Ireland Limited 001 milligram(s)/millil injection Prescription Only use Injection itre Medicine as - Intravenous defined in use relevant national - Subcutaneous legislation use

Marbocyl 2 %w/v Vetoquinol VPA10983/032/ 20 Solution for - QJ01MA93 POM: - Marbofloxacin - Intramuscular Solution for Ireland Limited 001 milligram(s)/millil injection Prescription Only use Injection itre Medicine as - Intravenous defined in use relevant national - Subcutaneous legislation use

Marbocyl P 20 Vetoquinol VPA10983/054/ 20 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Full application - Oral use mg Tablets Ireland Limited 002 Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Marbocyl P 5 mg Vetoquinol VPA10983/054/ 5 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Full application - Oral use Tablets Ireland Limited 001 Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Marbocyl P 80 Vetoquinol VPA10983/054/ 80 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Full application - Oral use mg Tablets Ireland Limited 003 Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 113 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Marbodug 100 Emdoka bvba VPA10534/006/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular mg/ml Solution 002 milligram(s)/millil injection Prescription Only application use for Injection for itre Medicine as (Article 13(1) of - Intravenous Cattle and Pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Marbodug 20 Emdoka bvba VPA10534/006/ 20 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular mg/ml solution 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Marbonor 100 Norbrook VPA22664/100/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only application use for Injection for (Ireland) Limited itre Medicine as (Article 13(1) of - Intravenous cattle and pig defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Marbosyva 100 Laboratorios VPA10495/003/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular mg/ml solution SYVA, S.A.U 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Marbox 100 Ceva Santé VPA10815/014/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular mg/ml solution Animale 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle and pigs defined in Directive No use relevant national 2001/82/EC) legislation

Marfloxin 100 Krka, d.d., Novo VPA10774/014/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular mg/ml solution mesto 002 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Marfloxin 20 mg Krka, d.d., Novo VPA10774/016/ 20 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use tablets for dogs mesto 002 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Marfloxin 20 Krka, d.d., Novo VPA10774/014/ 20 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous calves, pigs, defined in Directive No use dogs and cats relevant national 2001/82/EC) - Subcutaneous legislation use

Marfloxin 5 mg Krka, d.d., Novo VPA10774/016/ 5 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use tablets for cats mesto 001 Prescription Only application and dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Marfloxin 80 mg Krka, d.d., Novo VPA10774/016/ 80 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use tablets for dogs mesto 003 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 114 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration MASTERFLOX FATRO S.p.A. VPA10836/003/ 40 Solution for - QJ01MA93 POM: - Marbofloxacin Hybrid - Intramuscular 40 mg/ml 001 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(3) of injection for pigs defined in Directive No relevant national 2001/82/EC) legislation

Mastermectin ECO Animal VPA22693/022/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin Informed - Topical use 0.5% Pour-On Health Europe 001 weight/volume Prescription Only consent Solution for Limited Medicine as application Cattle defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Mastermectin 10 ECO Animal VPA22693/021/ 10 Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous mg/ml Solution Health Europe 001 milligram(s)/millil injection Prescription Only use for injection for Limited itre Medicine as cattle, sheep and defined in pigs relevant national legislation

Mastiplan LC, Intervet Ireland VPA10996/205/ 300, 20 Intramammary - QJ51RV01 POM: - Cefapirin Fixed - Intramammary 300mg/20mg Limited 001 mg/syringe suspension Prescription Only - Prednisolone combination use (Cefapirin/Predn Medicine as application isolone), defined in (Article 13b of intramammary relevant national Directive No suspension for legislation 2001/82/EC) lactating cows MASTRACIN LHV Bonapp HOVR10466/00 Oral solution LM: Licensed - Silicea - Oral use 4/001 Merchant as - Carbo defined in vegetabilis relevant national legislation

Maximec Horse Bimeda Animal VPA22033/028/ 18.7 Oral paste - QP54AA01 POM: - Ivermectin - Oral use Oral Paste 18.7 Health Limited 001 milligram(s)/gra Prescription Only mg/g m Medicine as defined in relevant national legislation

Maximec Bimeda Animal VPA22033/063/ 1 percent Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous Injection for Pigs Health Limited 001 weight/volume injection Prescription Only use 1% w/v Solution Medicine as for Injection defined in relevant national legislation

Maxoject 10 Chem-Pharm VPA10823/006/ 10
percent Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular %w/v Solution 001 weight/volume injection Prescription Only hydrochloride consent use for Injection Medicine as application - Intravenous defined in (Article 13c of use relevant national Directive No legislation 2001/82/EC)

Maxoject LA 200 Chem-Pharm VPA10823/007/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only consent use for Injection itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

MAXYL 500 Vetpharma VPA10516/011/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - Oral use mg/g POWDER Animal Health, 001 milligram(s)/gra in drinking water Prescription Only trihydrate application FOR USE IN S.L. m Medicine as (Article 13(1) of DRINKING defined in Directive No WATER FOR relevant national 2001/82/EC) CHICKENS, legislation TURKEYS, DUCKS AND PIGS

Veterinary Medicines Authorised/Transfer Pending Products Page 115 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Mectaject 1% Bimeda Animal VPA22033/064/ 1 percent Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous w/v Solution for Health Limited 001 weight/volume injection Prescription Only application use Injection Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Mectaject Plus Bimeda Animal VPA22033/029/ 10, 100 Solution for - QP54AA51 POM: - Ivermectin Informed - Subcutaneous Solution for Health Limited 001 milligram(s)/millil injection Prescription Only - Clorsulon consent use Injection itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Medesedan 10 CP-Pharma VPA10810/003/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomindine Generic - Intramuscular mg/ml, Solution Handelsgesellsc 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for Injection for haft mbH itre as defined in (Article 13(1) of - Intravenous Horses and relevant national Directive No use Cattle legislation 2001/82/EC)

Medetor 1 mg/ml CP-Pharma VPA10810/002/ 1.0 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Generic - Intramuscular Solution for Handelsgesellsc 001 milligram(s)/millil injection Practitioner Only hydrochloride application use Injection for Dog haft mbH itre as defined in (Article 13(1) of - Intravenous and Cat relevant national Directive No use legislation 2001/82/EC)

Medimec 0.5 Chanelle VPA10987/153/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin - Topical use %w/v Pour-on Pharmaceuticals 001 weight/volume Prescription Only Solution Manufacturing Medicine as Limited defined in relevant national legislation

Medimec Chanelle VPA10987/156/ 10 Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous Injection 10 Pharmaceuticals 001 milligram(s)/millil injection Prescription Only use mg/ml solution Manufacturing itre Medicine as for injection Limited defined in relevant national legislation

Megacal-M Ballinskelligs VPA10956/001/ 4.6, 2.0, 0.8 Solution for - QA12A LM: Licensed - Calcium ZZZ Complete - Intravenous Injection Vet. Products Lt 001 percent injection Merchant as borogluconate application use weight/volume defined in - Magnesium (stand-alone) - - Subcutaneous relevant national hypophosphite Council Directive use legislation - Magnesium 81/851/EEC hypophosphite Megapen - Strep Franklin VPA10976/008/ 200, 200 Suspension for - QJ01RA POM: - Procaine Full application - Intramuscular Injection Pharmaceuticals 001 milligram(s)/millil injection Prescription Only benzylpenicillin (Article 12(3) of use Ltd. itre Medicine as - Directive No defined in Dihydrostreptom 2001/82/EC) relevant national ycin sulphate legislation

Mektix 12.5 Krka, d.d., Novo VPA10774/061/ 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

Mektix 12.5 Krka, d.d., Novo VPA10774/061/ 12.5,125 Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use mg/125 mg film- mesto 004 mg/tablet tablet Prescription Only oxime application coated tablets for Medicine as - Praziquantel (Article 13(1) of dogs weighing at defined in Directive No least 5 kg relevant national 2001/82/EC) legislation

Mektix 16 mg/40 Krka, d.d., Novo VPA10774/062/ 16, 40 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg chewable mesto 002 Prescription Only oxime application tablets for cats Medicine as - Praziquantel (Article 13(1) of weighing at least defined in Directive No 2 kg relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 116 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Mektix 2.5 mg/25 Krka, d.d., Novo VPA10774/061/ 2.5, 25.0 Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg chewable mesto 001 mg/tablet Prescription Only oxime application tablets for small Medicine as - Praziquantel (Article 13(1) of dogs and defined in Directive No puppies relevant national 2001/82/EC) weighing at least legislation 0.5 kg

Mektix 2.5 mg/25 Krka, d.d., Novo VPA10774/061/ 2.5,25 mg/tablet Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use mg film-coated mesto 003 tablet Prescription Only oxime application tablets for small Medicine as - Praziquantel (Article 13(1) of dogs and defined in Directive No puppies relevant national 2001/82/EC) weighing at least legislation 0.5 kg Mektix 4 mg/10 Krka, d.d., Novo VPA10774/062/ 4, 10 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg chewable mesto 001 Prescription Only oxime application tablets for small Medicine as - Praziquantel (Article 13(1) of cats and kittens defined in Directive No weighing at least relevant national 2001/82/EC) 0.5 kg legislation

Menbutil 100 aniMedica VPA10826/023/ 100 Solution for - QA05AX90 POM: - Menbutone Generic - Intramuscular mg/ml solution GmbH 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, pigs, defined in Directive No use horses, sheep relevant national 2001/82/EC) and goats legislation

Mepiblock 20 Dechra VPA22622/012/ 20 Solution for - QN01BB03 POM: - Mepivacaine Hybrid - Epidural use mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Prescription Only hydrochloride application - Intraarticular for injection for itre Medicine as (Article 13(3) of use horses defined in Directive No relevant national 2001/82/EC) legislation

Mepidor 20 Richter Pharma VPA10801/010/ 20 Solution for - QN01BB03 VPO: Veterinary - Mepivacaine Hybrid - Epidural use mg/ml solution AG 001 milligram(s)/millil injection Practitioner Only hydrochloride application - Intraarticular for injection for itre as defined in (Article 13(3) of use horses relevant national Directive No legislation 2001/82/EC)

Merilym 3, Boehringer VPA10454/069/ . Suspension for - QI07AB04 POM: - Borrelia garinii Full application - Subcutaneous suspension for Ingelheim 001 injection Prescription Only - Borrelia afzelii (Article 12(3) of use injection for dogs Vetmedica Medicine as - Borrelia Directive No GmbH defined in burgdorferi 2001/82/EC) relevant national sensu stricto legislation

Metaxol 20/100 Eurovet Animal VPA10989/066/ 20, 100 Oral solution - QJ01EW11 POM: - Trimethoprim Generic - Oral use mg/ml solution Health B.V. 001 milligram(s)/millil Prescription Only - application for use in itre Medicine as Sulfamethoxazo (Article 13(1) of drinking water for defined in le Directive No pigs and relevant national 2001/82/EC) chickens legislation

Metomotyl 2.5 Le Vet Beheer VPA10475/009/ 2.5 Solution for - QA03FA01 POM: - Hybrid - Intramuscular mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only Metoclopramide application use for injection for itre Medicine as (as hydrochloride (Article 13(3) of - Subcutaneous cats and dogs defined in monohydrate) Directive No use relevant national 2001/82/EC) legislation

Metomotyl 5 Le Vet Beheer VPA10475/009/ 5 Solution for - QA03FA01 POM: - Generic - Intramuscular mg/ml solution B.V. 002 milligram(s)/millil injection Prescription Only Metoclopramide application use for injection for itre Medicine as (as hydrochloride (Article 13(1) of - Subcutaneous cats and dogs defined in monohydrate) Directive No use relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 117 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Metricure 500 Intervet Ireland VPA10996/053/ 500 mg/syringe Intrauterine - QG51AA POM: - Cephapirin - Intrauterine use mg Intrauterine Limited 001 suspension Prescription Only Suspension Medicine as defined in relevant national legislation

Metrobactin 250 Le Vet Beheer VPA10475/022/ 250 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Oral use mg tablets for B.V. 001 Prescription Only application dogs and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Metrobactin 500 Le Vet Beheer VPA10475/022/ 500 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Oral use mg tablets for B.V. 002 Prescription Only application dogs and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Metrocare Ecuphar NV VPA10491/012/ 250 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Oral use Flavour 250 mg 001 Prescription Only application tablets for dogs Medicine as (Article 13(1) of and cats defined in Directive No relevant national 2001/82/EC) legislation

Metrocare Ecuphar NV VPA10491/012/ 500 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Hybrid - Oral use Flavour 500 mg 002 Prescription Only application tablets for dogs Medicine as (Article 13(3) of and cats defined in Directive No relevant national 2001/82/EC) legislation

Metrotab vet. CP-Pharma VPA10810/021/ 1000 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Hybrid - Oral use Flavoured 1000 Handelsgesellsc 003 Prescription Only application mg tablets for haft mbH Medicine as (Article 13(3) of dogs defined in Directive No relevant national 2001/82/EC) legislation

Metrotab vet. CP-Pharma VPA10810/021/ 250 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Oral use Flavoured 250 Handelsgesellsc 001 Prescription Only application mg tablets for haft mbH Medicine as (Article 13(1) of dogs and cats defined in Directive No relevant national 2001/82/EC) legislation

Metrotab vet. CP-Pharma VPA10810/021/ 500 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Hybrid - Oral use Flavoured 500 Handelsgesellsc 002 Prescription Only application mg tablets for haft mbH Medicine as (Article 13(3) of dogs and cats defined in Directive No relevant national 2001/82/EC) legislation

Metrovis 100 mg LIVISTO Int'l, VPA10425/011/ 100 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Per Oral tablets for dogs S.L. 001 Prescription Only application and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Metrovis 250 mg LIVISTO Int'l, VPA10425/011/ 250 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Per Oral tablets for dogs S.L. 002 Prescription Only application and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 118 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Metrovis 750 mg LIVISTO Int'l, VPA10425/011/ 750 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Per Oral tablets for dogs S.L. 003 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Micotil 300 Elanco GmbH VPA22020/019/ 300 Solution for - QJ01FA91 VPO: Veterinary - Tilmicosin - Subcutaneous mg/ml Solution 001 milligram(s)/millil injection Practitioner Only use for Injection itre as defined in relevant national legislation

Milaxyn Plus Chanelle VPA10987/083/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use Tablets for dogs Pharmaceuticals 001 mg/tablet Companion - Febantel application Manufacturing Animal Medicine - Pyrantel (Article 13(3) of Limited as defined in embonate Directive No relevant national 2001/82/EC) legislation

Milaxyn Plus XL Chanelle VPA10987/083/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Febantel application Manufacturing - QP52AF02 Animal Medicine - Pyrantel (Article 13(3) of Limited as defined in embonate Directive No relevant national 2001/82/EC) legislation

Milbactor 12.5 Krka, d.d., Novo VPA10774/030/ 12.5, 125.0 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/125 mg mesto 002 mg/tablet Prescription Only oxime application tablets for dogs Medicine as - Praziquantel (Article 13(1) of weighing at least defined in Directive No 5 kg relevant national 2001/82/EC) legislation

Milbactor 16 Krka, d.d., Novo VPA10774/032/ 16, 40 mg/tablet Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use mg/40 mg film- mesto 002 tablet Prescription Only oxime application coated tablets for Medicine as - Praziquantel (Article 13(1) of cats weighing at defined in Directive No least 2 kg relevant national 2001/82/EC) legislation

Milbactor 2.5 Krka, d.d., Novo VPA10774/030/ 2.5, 25.0 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/25 mg tablets mesto 001 mg/tablet Prescription Only oxime application for small dogs Medicine as - Praziquantel (Article 13(1) of and puppies defined in Directive No weighing at least relevant national 2001/82/EC) 0.5 kg legislation

Milbactor 4 Krka, d.d., Novo VPA10774/032/ 4, 10 mg/tablet Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use mg/10 mg film- mesto 001 tablet Prescription Only oxime application coated tablets for Medicine as - Praziquantel (Article 13(1) of small cats and defined in Directive No kittens weighing relevant national 2001/82/EC) at least 0.5 kg legislation

MILBEMAX Elanco GmbH VPA22020/008/ 12.5, 125.0 Chewable tablet - QP54AB51 POM: - Milbemycin Full application - Oral use chewable tablets 004 mg/tablet Prescription Only oxime (Article 12(3) of for dogs Medicine as - Praziquantel Directive No defined in 2001/82/EC) relevant national legislation

MILBEMAX Elanco GmbH VPA22020/008/ 2.5, 25 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Full application - Oral use chewable tablets 003 Prescription Only oxime (Article 12(3) of for small dogs Medicine as - Praziquantel Directive No and puppies defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 119 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration MILBEMAX film- Elanco GmbH VPA22020/009/ 16.00, 40.00 Film-coated - QP54AB51 POM: - Milbemycin Fixed - Oral use coated tablets for 002 mg/tablet tablet Prescription Only oxime combination cats Medicine as - Praziquantel application defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

MILBEMAX film- Elanco GmbH VPA22020/009/ 4.0, 10.0 Film-coated - QP54AB51 POM: - Milbemycin Fixed - Oral use coated tablets for 001 mg/tablet tablet Prescription Only oxime combination small cats and Medicine as - Praziquantel application kittens defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

MILBEMAX Elanco GmbH VPA22020/008/ 2.5, 25.0 Tablet - QP54AB51 POM: - Milbemycin Fixed - Oral use tablets for small 001 mg/tablet Prescription Only oxime combination dogs and Medicine as - Praziquantel application puppies defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

MILBEMAX® Elanco GmbH VPA22020/008/ 12.5, 125.0 Tablet - QP54AB51 POM: - Milbemycin Fixed - Oral use tablets for dogs 002 mg/tablet Prescription Only oxime combination Medicine as - Praziquantel application defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Milbetab 12.5 Chanelle VPA10987/135/ 12.5, 125 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/125 mg Pharmaceuticals 001 mg/tablet Prescription Only oxime application Tablets for Dogs Manufacturing Medicine as - Praziquantel (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Milbetrin 12.5 Chanelle VPA10987/137/ 12.5, 125 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/125 mg Pharmaceuticals 001 mg/tablet Prescription Only oxime application Tablets for Dogs Manufacturing Medicine as - Praziquantel (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Milbotyl 300 Chanelle VPA10987/075/ 300 Solution for - QJ01FA91 VPO: Veterinary - Tilmicosin Generic - Subcutaneous mg/ml solution Pharmaceuticals 001 milligram(s)/millil injection Practitioner Only application use for injection Manufacturing itre as defined in (Article 13(1) of Limited relevant national Directive No legislation 2001/82/EC)

Milgusto 12.5 Krka, d.d., Novo VPA10774/063/ 12.5/125 Film-coated - QP54AB01 POM: - Milbemycin Generic - Oral use mg/125 mg film- mesto 004 mg/tablet tablet Prescription Only oxime application coated tablets for Medicine as - Praziquantel (Article 13(1) of dogs weighing at defined in Directive No least 5 kg relevant national 2001/82/EC) legislation

Milgusto 16 Krka, d.d., Novo VPA10774/064/ 16, 40 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/40 mg mesto 002 Prescription Only oxime application chewable tablets Medicine as - Praziquantel (Article 13(1) of for cats weighing defined in Directive No at least 2 kg relevant national 2001/82/EC) legislation

Milgusto 2.5 Krka, d.d., Novo VPA10774/063/ 2.5/25 mg/tablet Film-coated - QP54AB01 POM: - Milbemycin Generic - Oral use mg/25 mg film- mesto 003 tablet Prescription Only oxime application coated tablets for Medicine as - Praziquantel (Article 13(1) of small dogs and defined in Directive No puppies relevant national 2001/82/EC) weighing at least legislation 0.5 kg

Veterinary Medicines Authorised/Transfer Pending Products Page 120 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Milgusto 4 mg/10 Krka, d.d., Novo VPA10774/064/ 4, 10 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg chewable mesto 001 Prescription Only oxime application tablets for small Medicine as - Praziquantel (Article 13(1) of cats and kittens defined in Directive No weighing at least relevant national 2001/82/EC) 0.5 kg legislation

Milipraz 12.5 Chanelle VPA10987/136/ 12.5 mg, 125 mg Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/125 mg Pharmaceuticals 001 mg/tablet Prescription Only oxime application Tablets for Dogs Manufacturing Medicine as - Praziquantel (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Milprazon 12.5 Krka, d.d., Novo VPA10774/029/ 12.5, 125.0 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/125 mg mesto 002 mg/tablet Prescription Only oxime application tablets for dogs Medicine as - Praziquantel (Article 13(1) of weighing at least defined in Directive No 5 kg relevant national 2001/82/EC) legislation

Milprazon 16 Krka, d.d., Novo VPA10774/031/ 16, 40 mg/tablet Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use mg/40 mg film- mesto 002 tablet Prescription Only oxime application coated tablets for Medicine as - Praziquantel (Article 13(1) of cats weighing at defined in Directive No least 2 kg relevant national 2001/82/EC) legislation

Milprazon 2.5 Krka, d.d., Novo VPA10774/029/ 2.5, 25.0 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use mg/25 mg tablets mesto 001 mg/tablet Prescription Only oxime application for small dogs Medicine as - Praziquantel (Article 13(1) of and puppies defined in Directive No weighing at least relevant national 2001/82/EC) 0.5 kg legislation

Milprazon 4 Krka, d.d., Novo VPA10774/031/ 4, 10 mg/tablet Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use mg/10 mg film- mesto 001 tablet Prescription Only oxime application coated tablets for Medicine as - Praziquantel (Article 13(1) of small cats and defined in Directive No kittens weighing relevant national 2001/82/EC) at least 0.5 kg legislation

Milpro 12.5 Virbac S.A. VPA10988/095/ 12.5, 125 Tablet - QP54AB51 POM: - Milbemycin Hybrid - Oral use mg/125 mg film- 002 mg/tablet Prescription Only oxime application coated tablets for Medicine as - Praziquantel (Article 13(3) of dogs defined in Directive No relevant national 2001/82/EC) legislation

Milpro 16 mg/40 Virbac S.A. VPA10988/096/ 16, 40 mg/tablet Tablet - QP54AB51 POM: - Milbemycin Hybrid - Oral use mg film-coated 002 Prescription Only oxime application tablets for cats Medicine as - Praziquantel (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Milpro 2.5 mg/25 Virbac S.A. VPA10988/095/ 2.5, 25.0 Tablet - QP54AB51 POM: - Milbemycin Hybrid - Oral use mg film-coated 001 mg/tablet Prescription Only oxime application tablets for small Medicine as - Praziquantel (Article 13(3) of dogs and defined in Directive No puppies relevant national 2001/82/EC) legislation

Milpro 4 mg/10 Virbac S.A. VPA10988/096/ 4, 10 mg/tablet Tablet - QP54AB51 POM: - Milbemycin Hybrid - Oral use mg film-coated 001 Prescription Only oxime application tablets for small Medicine as - Praziquantel (Article 13(3) of cats and kittens defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 121 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Modulis 100 Ceva Santé VPA10815/043/ 100 Oral solution - QL04AA01 POM: - Ciclosporin Generic - Oral use mg/ml oral Animale 001 milligram(s)/millil Prescription Only application solution for dogs itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Morlam Laboratories VPA10396/001/ 60 mg/sponge Medicated - QG03DA02 POM: - Full application - Vaginal use Intravaginal Ovejero S.A. 001 sponge Prescription Only Medroxyprogest (Article 12(3) of Sponge Medicine as erone acetate Directive No defined in 2001/82/EC) relevant national legislation

Morphasol 10 aniMedica VPA10826/009/ 10 Solution for - QN02AF01 POM: - Butorphanol Hybrid - Intravenous mg/ml solution GmbH 001 milligram(s)/millil injection Prescription Only tartrate application use for injection for itre Medicine as (Article 13(3) of horses defined in Directive No relevant national 2001/82/EC) legislation

Morphasol 4 aniMedica VPA10826/007/ 4 Solution for - QN02AF01 POM: - Butorphanol Well-established - Intravenous mg/ml solution GmbH 001 milligram(s)/millil injection Prescription Only tartrate use application use for injection for itre Medicine as (Article 13a of dogs and cats defined in Directive No relevant national 2001/82/EC) legislation

MOXAPULVIS V.M.D. n.v/s.a. VPA10817/003/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Hybrid - Oral use 500 mg/g 001 milligram(s)/gra in drinking water Prescription Only trihydrate application powder for use in m Medicine as (Article 13(3) of drinking water defined in Directive No relevant national 2001/82/EC) legislation

Moxiclear 100 Norbrook VPA22664/140/ 100, 25 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use mg + 25 mg Laboratories 002 mg/pipette Prescription Only - Moxidectin application spot-on solution (Ireland) Limited Medicine as (Article 13(1) of for medium dogs defined in Directive No relevant national 2001/82/EC) legislation

Moxiclear 250 Norbrook VPA22664/140/ 250, 62.5 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use mg + 62.5 mg Laboratories 003 mg/pipette Prescription Only - Moxidectin application spot-on solution (Ireland) Limited Medicine as (Article 13(1) of for large dogs defined in Directive No relevant national 2001/82/EC) legislation

Moxiclear 40 mg Norbrook VPA22664/140/ 40, 10 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use + 10 mg spot-on Laboratories 001 mg/pipette Prescription Only - Moxidectin application solution for small (Ireland) Limited Medicine as (Article 13(1) of dogs defined in Directive No relevant national 2001/82/EC) legislation

Moxiclear 40 mg Norbrook VPA22664/139/ 40, 4 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use + 4 mg spot-on Laboratories 001 Prescription Only - Moxidectin application solution for small (Ireland) Limited Medicine as (Article 13(1) of cats and ferrets defined in Directive No relevant national 2001/82/EC) legislation

Moxiclear 400 Norbrook VPA22664/140/ 400, 100 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use mg + 100 mg Laboratories 004 mg/pipette Prescription Only - Moxidectin application spot-on solution (Ireland) Limited Medicine as (Article 13(1) of for very-large defined in Directive No dogs relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 122 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Moxiclear 80 mg Norbrook VPA22664/139/ 80, 8 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use + 8 mg spot-on Laboratories 002 Prescription Only - Moxidectin application solution for large (Ireland) Limited Medicine as (Article 13(1) of cats defined in Directive No relevant national 2001/82/EC) legislation

Moxodex 1 Chanelle VPA10987/111/ 1 Oral solution - QP54AB02 POM: - Moxidectin Generic - Oral use mg/ml oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application solution for Manufacturing itre Medicine as (Article 13(1) of sheep Limited defined in Directive No relevant national 2001/82/EC) legislation

Moxodex 5 Chanelle VPA10987/129/ 5 Pour-on solution - QP54AB02 POM: - Moxidectin Generic - Topical mg/ml Pour-on Pharmaceuticals 001 milligram(s)/millil Prescription Only application solution for cattle Manufacturing itre Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Multiject IMM Norbrook VPA22664/008/ 100,000 Intramammary - QJ51RV01 POM: - Procaine Well-established - Intramammary Intramammary Laboratories 001 international suspension Prescription Only benzylpenicillin use application use Suspension (Ireland) Limited unit(s) Medicine as - Streptomycin (Article 13a of defined in sulphate Directive No relevant national - Neomycin 2001/82/EC) legislation sulphate - Prednisolone Multimast Dry Bimeda Animal VPA22033/030/ 100, 100, 400 Intramammary - QJ51RC POM: - Neomycin Informed - Intramammary Cow Health Limited 001 mg/syringe suspension Prescription Only sulphate consent use Intramammary Medicine as - Penethamate application Suspension defined in hydriodide (Article 13c of relevant national - Procaine Directive No legislation benzylpenicillin 2001/82/EC)

Multimin Solution Warburton VPA10431/001/ 60, 10, 15, 5 Solution for - QA12CX99 POM: - Zinc oxide Full application - Subcutaneous for Injection for Technology 001 milligram(s)/millil injection Prescription Only - Copper (Article 12(3) of use Cattle Limited itre Medicine as carbonate Directive No defined in - Sodium 2001/82/EC) relevant national selenite legislation - Manganese Carbonate Multishield DC Bimeda Animal VPA22033/065/ 70000 IU, 77.2 Intramammary - QJ51RC POM: - Neomycin Generic - Intramammary Intramammary Health Limited 001 mg, 227.2 mg suspension Prescription Only sulphate application use Suspension for per syringe Medicine as - Penethamate (Article 13(1) of Cows defined in hydriodide Directive No relevant national - Procaine 2001/82/EC) legislation benzylpenicillin

Multivitamin Chem-Pharm VPA10823/017/ .
Solution for - QA11JA LM: Licensed - Vitamin A Informed - Intramuscular Injection 001 injection Merchant as palmitate consent use defined in - Vitamin D3 application - Subcutaneous relevant national - Vitamin E (Article 13c of use legislation acetate Directive No - Thiamine 2001/82/EC) hydrochloride - Riboflavin sodium phosphate - Pyridoxine hydrochloride - Nicotinamide - Dexpanthenol - Vitamin B12 MUSTELIGEN D Virbac S.A. VPA10988/113/ 10^2.9 - 10^5.1 Lyophilisate and - QI20DD01 POM: - Canine Full application - Subcutaneous lyophilisate and 001 cell culture solvent for Prescription Only Distemper Virus, (Article 12(3) of use solvent for infective dose suspension for Medicine as Strain Lederle, Directive No suspension for 50/dose injection defined in Live 2001/82/EC) injection for relevant national ferrets legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 123 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration MYCOFLOR 200 SP Veterinaria, VPA10790/007/ 200 Concentrate for - QJ01BA90 POM: - Florfenicol Hybrid - In drinking mg/ml solution S.A. 001 milligram(s)/millil use in drinking Prescription Only application water use for use in itre water Medicine as (Article 13(3) of drinking water for defined in Directive No pigs relevant national 2001/82/EC) legislation

MYCOFLOR, SP Veterinaria, VPA10790/004/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular 300 mg/ml S.A. 001 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle and pigs relevant national 2001/82/EC) legislation

Mycomas 100 Univet Limited VPA10990/047/ 100 Solution for use - QJ01MA90 POM: - Enrofloxacin Informed - In drinking mg/ml Solution 001 milligram(s)/millil in drinking water Prescription Only consent water use for use in itre Medicine as application drinking water defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Myodine 25 Le Vet Beheer VPA10475/027/ 25 Solution for - QA14AB01 POM: - Nandrolone Generic - Intramuscular mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only Laurate application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous dogs and cats defined in Directive No use relevant national 2001/82/EC) legislation

Myolone 25 Le Vet Beheer VPA10475/042/ 25 Solution for - QA14AB01 POM: - Nandrolone Generic - Intramuscular mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only laurate application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous dogs and cats defined in Directive No use relevant national 2001/82/EC) legislation

MYPRAVAC Laboratorios VPA10846/004/ 50 percent Suspension for - QI09AB13 LM: Licensed - Inactivated Fixed - Intramuscular SUISSuspension Hipra S.A. 001 injection Merchant as Mycoplasma combination use for injection defined in hyopneumoniae application relevant national strain J (Article 13b of legislation Directive No 2001/82/EC) Nafpenzal DC Intervet Ireland VPA10996/074/ 300, 100, 100 Intramammary - QJ51RC23 POM: - Procaine Full application - Intramammary Intramammary Limited 001 mg/syringe suspension Prescription Only benzylpenicillin (Article 12(3) of use Suspension Medicine as - Directive No defined in Dihydrostreptom 2001/82/EC) relevant national ycin sulphate legislation - Nafcillin sodium

Nandrosol 25 CP-Pharma VPA10810/015/ 25 Solution for - QA14AB01 POM: - Nandrolone Generic - Intramuscular mg/ml solution Handelsgesellsc 001 milligram(s)/millil injection Prescription Only laurate application use for injection for haft mbH itre Medicine as (Article 13(1) of - Subcutaneous dogs and cats defined in Directive No use relevant national 2001/82/EC) legislation

Narketan-10 100 Vetoquinol VPA10983/055/ 100 Solution for - QN01AX03 VPO: Veterinary - Ketamine ZZZ Informed - Intramuscular mg/ml Solution Ireland Limited 001 milligram(s)/millil injection Practitioner Only hydrochloride consent use for Injection itre as defined in (abridged - Intravenous relevant national application) - use legislation Council Directive - Subcutaneous 81/851/EEC use

NEFOTEK 100 Vetpharma VPA10516/005/ 100 Solution for - QM01AE03 POM: - Ketoprofen Generic - Intramuscular mg/ml solution Animal Health, 001 milligram(s)/millil injection Prescription Only application use for injection for S.L. itre Medicine as (Article 13(1) of - Intravenous cattle, horses defined in Directive No use and pigs relevant national 2001/82/EC) legislation

Nelio 2.5 mg Ceva Santé VPA10815/031/ 2.5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Full application - Oral use Tablet for Cats Animale 002 Prescription Only hydrochloride (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 124 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Nelio 20 mg Ceva Santé VPA10815/032/ 20 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use Tablet for dogs Animale 002 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Nelio 5 mg tablet Ceva Santé VPA10815/031/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use for cats Animale 001 Prescription Only hydrochloride application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Nelio 5 mg Ceva Santé VPA10815/032/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use Tablet for Dogs Animale 001 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Nematel-P 439 Le Vet Beheer VPA10475/005/ 439 Oral paste - QP52AF02 POM: - Pyrantel Well-established - Oral use mg/g oral paste B.V. 001 milligram(s)/gra Prescription Only embonate use application for horses m Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

NEMOVAC Boehringer VPA10454/070/ . Lyophilisate for - QI01AD01 POM: - Live Full application - Oral use Ingelheim 001 suspension Prescription Only pneumovirus, (Article 12(3) of Vetmedica Medicine as PL21 strain Directive No GmbH defined in 2001/82/EC) relevant national legislation

NEOMAY 500 Laboratorios VPA10436/003/ 500,000 Powder for use - QA07AA01 POM: - Neomycin Hybrid - In drinking 000 IU/g powder Maymó, S.A. 001 international in drinking Prescription Only application water use for use in unit(s)/gram water/milk Medicine as (Article 13(3) of drinking defined in Directive No water/milk relevant national 2001/82/EC) replacer legislation

Neopen Intervet Ireland VPA10996/006/ 100/200 Suspension for - QJ01RA01 POM: - Procaine ZZZ Complete - Intramuscular Suspension for Limited 002 milligram(s)/millil injection Prescription Only benzylpenicillin application use Injection itre Medicine as - Neomycin (stand-alone) - defined in sulphate Council Directive relevant national 81/851/EEC legislation

NEOPRINIL Virbac S.A. VPA10988/090/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Generic - Topical use POUR-ON 5 001 milligram(s)/millil Prescription Only application mg/ml pour-on itre Medicine as (Article 13(1) of solution for cattle defined in Directive No relevant national 2001/82/EC) legislation

NEOSKILAB 1.5 Labiana Life VPA10402/004/ 1.5 Solution for - QN07AA01 POM: - Neostigmine Generic - Intramuscular mg/ml solution Sciences, S.A. 001 milligram(s)/millil injection Prescription Only Metilsulfate application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle, sheep, defined in Directive No use goats and horse relevant national 2001/82/EC) legislation

Nerfasin 100 Le Vet BV VPA10816/013/ 100 Solution for - QN05CM92 VPO: Veterinary - Xylazine (as Generic - Intramuscular mg/ml, solution 002 milligram(s)/millil injection Practitioner Only hydrochloride) application use for injection for itre as defined in (Article 13(1) of - Intravenous cattle and horse relevant national Directive No use legislation 2001/82/EC) - Subcutaneous use

Veterinary Medicines Authorised/Transfer Pending Products Page 125 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Nerfasin 20 Le Vet BV VPA10816/013/ 20 Solution for - QN05CM92 VPO: Veterinary - Xylazine (as Generic - Intramuscular mg/ml, solution 001 milligram(s)/millil injection Practitioner Only hydrochloride) application use for injection for itre as defined in (Article 13(1) of - Intravenous cattle, horses, relevant national Directive No use dogs and cats legislation 2001/82/EC) - Subcutaneous use

Nexmectin 18.7 ECO Animal VPA22693/015/ 18.7 Oral paste - QP54AA01 POM: - Ivermectin Informed - Oral use mg/g Oral Paste Health Europe 001 milligram(s)/gra Prescription Only consent for Horses Limited m Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Nextmune CEVA-Phylaxia VPA10463/009/ . Concentrate and - QI01AD09 POM: - Live attenuated Full application - In ovo concentrate and Veterinary 001 solvent for Prescription Only IBD virus, (Article 12(3) of - Subcutaneous solvent for Biologicals Co. suspension for Medicine as serotype 1, strain Directive No use suspension for Ltd injection defined in G-61 2001/82/EC) injection for relevant national chickens legislation

NIFENCOL 100 Vetpharma VPA10516/009/ 100 Solution for use - QJ01BA90 POM: - Florfenicol Hybrid - Oral use mg/ml Solution Animal Health, 001 milligram(s)/millil in drinking water Prescription Only application for use in S.L. itre Medicine as (Article 13(3) of Drinking Water defined in Directive No for Pigs relevant national 2001/82/EC) legislation

Nifencol 300 Vetpharma VPA10516/007/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular mg/ml solution Animal Health, 001 milligram(s)/millil injection Prescription Only application use for injection for S.L. itre Medicine as (Article 13(1) of - Subcutaneous cattle and pigs defined in Directive No use relevant national 2001/82/EC) legislation

NIMATEK 100 Eurovet Animal VPA10989/062/ 100 Solution for - QN01AX03 VPO: Veterinary - Ketamine Hybrid - Intramuscular mg/ml, Solution Health B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for itre as defined in (Article 13(3) of - Intravenous dogs, cats and relevant national Directive No use horses legislation 2001/82/EC) - Subcutaneous use

Nobilis CAV P4 Intervet Ireland VPA10996/131/ . Lyophilisate and - QI01AD04 POM: - Chick anaemia Full application - Intramuscular Limited 001 solvent for Prescription Only agent virus strain (Article 12(3) of use suspension for Medicine as 26p4 Directive No - Subcutaneous injection defined in 2001/82/EC) use relevant national legislation

Nobilis Diluent Intervet Ireland VPA10996/203/ . - NOTREQ LM: Licensed Full application - Nasal use Oculo Nasal Limited 001 Merchant as (Article 12(3) of - Ocular use defined in Directive No relevant national 2001/82/EC) legislation

Nobilis E.coli Intervet Ireland VPA10996/083/ . Emulsion for - QI01AB05 POM: - F11-antigen (E. Full application - Intramuscular inac emulsion for Limited 001 injection Prescription Only coli fimbrial (Article 12(3) of use injection for Medicine as antigen) Directive No - Subcutaneous chickens defined in - FT-antigen (E. 2001/82/EC) use relevant national coli flagellar toxin legislation antigen)

Nobilis Gumboro Intervet Ireland VPA10996/134/ . Powder for oral - QI01AD09 POM: - Gumboro Full application - Oral use 228E Limited 001 solution Prescription Only disease virus (Article 12(3) of Medicine as strain 228e Directive No defined in 2001/82/EC) relevant national legislation

Nobilis Gumboro Intervet Ireland VPA10996/133/ . Lyophilisate for - QI01AD09 POM: - Gumboro Full application - Oral use D78 live Limited 001 suspension Prescription Only disease virus (Article 12(3) of Medicine as strain D78 Directive No defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 126 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Nobilis IB Ma5 Intervet Ireland VPA10996/136/ . Lyophilisate for - QI01AD07 POM: - Live attenuated Full application - Oculonasal use Limited 001 solution Prescription Only IB virus strain (Article 12(3) of - Oral use Medicine as Ma5 Directive No defined in 2001/82/EC) relevant national legislation

Nobilis Intervet Ireland VPA10996/094/ . Emulsion for - QI01AA13 POM: - Inactivated Full application - Intramuscular IB+ND+EDS Limited 001 injection Prescription Only infectious (Article 12(3) of use emulsion for Medicine as bronchitis virus, Directive No - Subcutaneous injection defined in mass41 strain 2001/82/EC) use relevant national - Inactivated ND legislation virus strain clone 30 inducing - Inactivated egg drop syndrome’ 76 inducing

Nobilis Intervet Ireland VPA10996/192/ . Emulsion for - QI01AA13 POM: - Infectious - Intramuscular IBmulti+ND+ED Limited 001 injection Prescription Only bronchitis virus use S Medicine as strain M41 - Subcutaneous defined in - Infectious use relevant national bronchitis virus legislation strain 249g - Egg drop syndrome’76 strain BC14 - Newcastle disease virus strain clone 30 Nobilis MS Live, Intervet Ireland VPA10996/269/ . Lyophilisate for - QI01AE03 POM: - Live attenuated Full application - ZZZ Spray lyophilisate for Limited 001 suspension Prescription Only mycoplasma (Article 12(3) of oculonasal Medicine as synoviae strain Directive No suspension for defined in ms1 2001/82/EC) chickens relevant national legislation

Nobilis ND C2 Intervet Ireland VPA10996/187/ . Lyophilisate for - QI01AD06 POM: - Live attenuated Full application - Nebulisation lyophilisate for Limited 001 oculonasal Prescription Only newcastle (Article 12(3) of use oculonasal suspension Medicine as disease virus Directive No - Oculonasal use suspension for defined in (ndv) strain c2 2001/82/EC) chickens relevant national legislation

Nobilis ND Clone Intervet Ireland VPA10996/091/ . Lyophilisate for - QI01AD06 POM: - Live newcastle Full application - Oral use 30 live Limited 001 suspension Prescription Only disease virus (Article 12(3) of Medicine as clone 30 Directive No defined in 2001/82/EC) relevant national legislation

Nobilis Rhino CV Intervet Ireland VPA10996/190/ . Lyophilisate for - QI01AD01 POM: - Live attenuated Full application - Nasal use Limited 001 suspension for Prescription Only avian (Article 12(3) of - Ocular use oculonasal or Medicine as rhinotracheitis Directive No - Oral use spray app defined in virus strain trt 2001/82/EC) relevant national 11/94 legislation

Nobilis Rismavac Intervet Ireland VPA10996/086/ 3.0 log10 - 4.1 Concentrate for - QI01AD03 POM: - Live chicken Full application - Intramuscular + CA126 Limited 001 log10 plaque solution for Prescription Only herpes virus (Article 12(3) of use forming unit injection Medicine as strain CVI-988 Directive No - Subcutaneous defined in - Live turkey 2001/82/EC) use relevant national herpes virus legislation strain FC126

Veterinary Medicines Authorised/Transfer Pending Products Page 127 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Nobilis Intervet Ireland VPA10996/087/ . Emulsion for - QI01AA18 POM: - Infectious Full application - Intramuscular RT+IBmulti+G+ Limited 001 injection Prescription Only bronchitis virus (Article 12(3) of use ND Medicine as strain M41 Directive No defined in - Infectious 2001/82/EC) relevant national bronchitis virus legislation strain 249g - Avian rhinotracheitis virus strain But1 #8544 (subgroup A) - Infectious bursal disease virus strain D78 - Newcastle disease virus strain clone 30 Nobilis Intervet Ireland VPA10996/181/ . Emulsion for - QI01AA18 POM: - Infectious Full application - Intramuscular RT+IBmulti+ND Limited 001 injection Prescription Only bronchitis virus (Article 12(3) of use +EDS Medicine as strain M41 (pre- Directive No defined in inactivation) 2001/82/EC) relevant national - Infectious legislation bronchitis virus strain 249g - Avian rhinotracheitis strain But1 #8544 - Egg drop syndrome 76 strain bc14 - Newcastle disease virus strain clone 30 Nobilis TRT inac Intervet Ireland VPA10996/180/ . Emulsion for - QI01AA17 POM: - Inactivated - Intramuscular Limited 001 injection Prescription Only avian use Medicine as rhinotracheitis defined in virus relevant national (BUT1#8544) legislation subtype A

Nobivac DHP Intervet Ireland VPA10996/174/ . Lyophilisate for - QI07AD02 POM: - Canine Full application - Subcutaneous Limited 001 suspension for Prescription Only distemper virus, (Article 12(3) of use injection Medicine as strain Directive No defined in onderstepoort 2001/82/EC) relevant national - Canine legislation adenovirus type 2 strain manhattan lpv3 (live) - Canine parvovirus strain 154 (live) Nobivac DHPPi Intervet Ireland VPA10996/166/ . Lyophilisate for - QI07AD04 POM: - Canine Full application - Subcutaneous Limited 001 solution for Prescription Only distemper virus (Article 12(3) of use injection Medicine as strain Directive No defined in ondertespoort 2001/82/EC) relevant national (live) legislation - Canine adenovirus type 2 strain manhattan lpv3 (live) - Canine parvovirus strain 154 (live) - Canine parainfluenza virus strain Cornell (Live)

Veterinary Medicines Authorised/Transfer Pending Products Page 128 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Nobivac Ducat Intervet Ireland VPA10996/182/ . Lyophilisate and - QI06AD03 POM: - Live feline Full application - Subcutaneous Limited 001 solvent for Prescription Only calicivirus, strain (Article 12(3) of use suspension for Medicine as F9 Directive No injection defined in - Live feline 2001/82/EC) relevant national rhinotracheitis legislation virus strain G2620A Nobivac KC Intervet Ireland VPA10996/129/ . Lyophilisate and - QI07AF POM: - Bordetella Full application - Intra-nasal Limited 001 solvent for nasal Prescription Only bronchiseptica (Article 12(3) of drops, Medicine as - Canine Directive No suspension defined in parainfluenza 2001/82/EC) relevant national legislation

Nobivac Lepto 2 Intervet Ireland VPA10996/169/ . Suspension for - QI07AB01 POM: - Leptospira Full application - Subcutaneous Suspension for Limited 001 injection Prescription Only interrogans (Article 12(3) of use Injection for Medicine as serogroup Directive No Dogs defined in icterohaemorrha 2001/82/EC) relevant national giae strain 820k legislation - Leptospira interrogans serogroup Canicola; serovar portland- vere, strain Ca- 12-000

Nobivac Parvo-C Intervet Ireland VPA10996/167/ . Lyophilisate for - QI07AD01 POM: - Canine Full application - Subcutaneous Limited 001 suspension for Prescription Only parvovirus (Article 12(3) of use injection Medicine as attenuated strain Directive No defined in 154 2001/82/EC) relevant national legislation

Nobivac Rabies Intervet Ireland VPA10996/170/ 2-6 International Suspension for - QI07AA02 POM: - Inactivated Full application - Intramuscular Limited 001 Units/dose injection Prescription Only rabies virus (Article 12(3) of use Medicine as antigen Directive No - Subcutaneous defined in suspension 2001/82/EC) use relevant national legislation

Nobivac Respira Intervet Ireland VPA10996/277/ . Suspension for - QI07AB03 POM: - Bordetella Full application - Subcutaneous Bb suspension Limited 002 injection Prescription Only Bronchiseptica (Article 12(3) of use for injection for Medicine as Fimbriae Directive No dogs defined in 2001/82/EC) relevant national legislation

Nobivac Respira Intervet Ireland VPA10996/277/ . Suspension for - QI07AB03 POM: - Bordetella Full application - Subcutaneous Bb suspension Limited 001 injection in pre- Prescription Only Bronchiseptica (Article 12(3) of use for injection in filled syringe Medicine as Fimbriae Directive No pre-filled syringe defined in 2001/82/EC) for dogs relevant national legislation

Nobivac Solvent Intervet Ireland VPA10996/177/ . Solvent for - QV07AB POM: Full application - Subcutaneous Limited 001 parenteral use Prescription Only (Article 12(3) of use Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Nobivac Tricat Intervet Ireland VPA10996/204/ . Lyophilisate and - QI06AD04 POM: - Feline Full application - Subcutaneous Trio, lyophilisate Limited 001 solvent for Prescription Only calicivrus, strain (Article 12(3) of use and solvent for suspension for Medicine as f9 live attenuated Directive No suspension for injection defined in - Feline herpes 2001/82/EC) injection, for cats relevant national virus type 1, legislation strain g2620a live attenuated - Feline panleucopenia virus, strain mw- 1 live attenuated

Veterinary Medicines Authorised/Transfer Pending Products Page 129 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Norbrook Fipronil Norbrook VPA22664/097/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use 134 mg Spot-On Laboratories 002 Prescription Only application Solution for (Ireland) Limited Medicine as (Article 13(3) of Medium Dogs defined in Directive No relevant national 2001/82/EC) legislation

Norbrook Fipronil Norbrook VPA22664/097/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use 268 mg Spot-On Laboratories 003 Prescription Only application Solution for (Ireland) Limited Medicine as (Article 13(3) of Large Dogs defined in Directive No relevant national 2001/82/EC) legislation

Norbrook Fipronil Norbrook VPA22664/097/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use 402 mg Spot-On Laboratories 004 Prescription Only application Solution for Very (Ireland) Limited Medicine as (Article 13(3) of Large Dogs defined in Directive No relevant national 2001/82/EC) legislation

Norbrook Fipronil Norbrook VPA22664/096/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use 50 mg Spot-On Laboratories 001 Prescription Only application Solution for cats (Ireland) Limited Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Norbrook Fipronil Norbrook VPA22664/097/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use 67 mg Spot-On Laboratories 001 Prescription Only application Solution for (Ireland) Limited Medicine as (Article 13(3) of Small Dogs defined in Directive No relevant national 2001/82/EC) legislation

Norbrook Fipronil Norbrook VPA22664/138/ 134, 120.6 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use and (S)- Laboratories 002 mg/pipette Merchant as - (S)-methoprene application Methoprene 134 (Ireland) Limited defined in (Article 13(1) of mg / 120.6 mg relevant national Directive No spot-on solution legislation 2001/82/EC) for medium dogs

Norbrook Fipronil Norbrook VPA22664/138/ 268, 241.2 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use and (S)- Laboratories 003 mg/pipette Merchant as - (S)-methoprene application Methoprene 268 (Ireland) Limited defined in (Article 13(1) of mg / 241.2 mg relevant national Directive No spot-on solution legislation 2001/82/EC) for large dogs

Norbrook Fipronil Norbrook VPA22664/138/ 402, 361.8 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use and (S)- Laboratories 004 mg/pipette Merchant as - (S)-methoprene application Methoprene 402 (Ireland) Limited defined in (Article 13(1) of mg / 361.8 mg relevant national Directive No spot-on solution legislation 2001/82/EC) for very large dogs Norbrook Fipronil Norbrook VPA22664/133/ 50, 60 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use and (S)- Laboratories 001 mg/pipette Merchant as - (S)-methoprene application Methoprene 50 (Ireland) Limited defined in (Article 13(1) of mg / 60 mg spot- relevant national Directive No on solution for legislation 2001/82/EC) cats and ferrets

Norbrook Fipronil Norbrook VPA22664/138/ 67, 60.3 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use and (S)- Laboratories 001 mg/pipette Merchant as - (S)-methoprene application Methoprene 67 (Ireland) Limited defined in (Article 13(1) of mg / 60.3 mg relevant national Directive No spot-on solution legislation 2001/82/EC) for small dogs

Veterinary Medicines Authorised/Transfer Pending Products Page 130 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Norfenicol 300 Norbrook VPA22664/093/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only application use for Injection for (Ireland) Limited itre Medicine as (Article 13(1) of - Subcutaneous Cattle and Pigs defined in Directive No use relevant national 2001/82/EC) legislation

Normazole 5 Norbrook VPA22664/145/ 5 Oral solution - QH03BB02 POM: - Thiamazole Hybrid - Oral use mg/ml Oral Laboratories 001 milligram(s)/millil Prescription Only application Solution for Cats (Ireland) Limited itre Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Norocarp 20 mg Norbrook VPA22664/067/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use Tablets for Dogs Laboratories 001 Prescription Only (Ireland) Limited Medicine as defined in relevant national legislation

Norocarp 50 mg Norbrook VPA22664/067/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use Tablets for Dogs Laboratories 002 Prescription Only (Ireland) Limited Medicine as defined in relevant national legislation

Norocarp 50 Norbrook VPA22664/073/ 50 Solution for - QM01AE91 POM: - Carprofen Well-established - Intravenous mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only use application use for Injection for (Ireland) Limited itre Medicine as (Article 13a of - Subcutaneous Cattle defined in Directive No use relevant national 2001/82/EC) legislation

Norocarp Large Norbrook VPA22664/074/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous Animal 5 %w/v Laboratories 001 milligram(s)/millil injection Prescription Only application use Solution for (Ireland) Limited itre Medicine as (Article 13(1) of - Subcutaneous Injection for defined in Directive No use young cattle, relevant national 2001/82/EC) horses and legislation ponies Norocillin 300 Norbrook VPA22664/012/ 300 Suspension for - QJ01CE01 POM: - Procaine Full application - Intramuscular mg/ml Laboratories 001 milligram(s)/millil injection Prescription Only benzylpenicillin (Article 12(3) of use Suspension for (Ireland) Limited itre Medicine as Directive No Injection defined in 2001/82/EC) relevant national legislation

Noroclav 250 mg Norbrook VPA22664/072/ 250 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use Tablets for dogs Laboratories 002 Prescription Only trihydrate (Ireland) Limited Medicine as - Potassium defined in clavulanate relevant national legislation

Noroclav 50 mg Norbrook VPA22664/072/ 50 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use Tablets for Dogs Laboratories 001 Prescription Only trihydrate and Cats (Ireland) Limited Medicine as - Potassium defined in clavulanate relevant national legislation

Noroclav 500 mg Norbrook VPA22664/082/ 500 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use Palatable Laboratories 001 Prescription Only trihydrate application Tablets for Dogs (Ireland) Limited Medicine as - Potassium (Article 13(1) of defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 131 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Noroclav Norbrook VPA22664/058/ 140, 35 percent Suspension for - QJ01CR02 POM: - Amoxicillin - Intramuscular Injection for Laboratories 001 weight/volume injection Prescription Only trihydrate use Cattle and Dogs (Ireland) Limited Medicine as - Potassium - Subcutaneous defined in clavulanate use relevant national legislation

Noroclav Norbrook VPA22664/090/ 200, 50, 10 Intramammary - QJ51RV01 POM: - Amoxicillin Hybrid - Intramammary Intramammary Laboratories 001 mg/syringe suspension Prescription Only trihydrate application use Suspension for (Ireland) Limited Medicine as - Prednisolone (Article 13(3) of Lactating Cows defined in - Potassium Directive No relevant national clavulanate 2001/82/EC) legislation

Noroclox DC Norbrook VPA22664/011/ 500 mg/syringe Intramammary - QJ51CF02 POM: - Cloxacillin - Intramammary Intramammary Laboratories 001 suspension Prescription Only Benzathine use Suspension (Ireland) Limited Medicine as defined in relevant national legislation

Noroclox DC Norbrook VPA22664/043/ 600 mg/syringe Intramammary - QJ51CF02 POM: - Cloxacillin - Intramammary Xtra Laboratories 001 suspension Prescription Only Benzathine use Intramammary (Ireland) Limited Medicine as Suspension defined in relevant national legislation

Norodine 24 % Norbrook VPA22664/021/ 24 percent Solution for - QJ01EW10 POM: - Trimethoprim Full application - Intramuscular Solution for Laboratories 001 weight/volume injection Prescription Only - Sulfadiazine (Article 12(3) of use Injection (Ireland) Limited Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national - Subcutaneous legislation use

Norodine Equine Norbrook VPA22664/019/ 5.8, 28.83 Oral paste - QJ01E POM: - Trimethoprim Full application - Oral use Oral Paste Laboratories 001 percent Prescription Only - Sulfadiazine (Article 12(3) of (Ireland) Limited weight/weight Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Noromectin 0.5% Norbrook VPA22664/052/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin Generic - Topical use w/v Pour-On Laboratories 001 weight/volume Prescription Only application Solution for (Ireland) Limited Medicine as (Article 13(1) of Cattle defined in Directive No relevant national 2001/82/EC) legislation

Noromectin 1% Norbrook VPA22664/051/ 1.0 percent Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous w/v Solution for Laboratories 001 weight/volume injection Prescription Only application use Injection for (Ireland) Limited Medicine as (Article 13(1) of Cattle and Pigs defined in Directive No relevant national 2001/82/EC) legislation

Noromectin 1.0 Norbrook VPA22664/059/ 1.0 percent Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous % w/v Solution Laboratories 001 weight/volume injection Prescription Only use for Injection for (Ireland) Limited Medicine as Sheep defined in relevant national legislation

Noromectin Norbrook VPA22664/062/ 1.87 percent Oral paste - QP54AA01 POM: - Ivermectin Well-established - Oral use 1.87% Oral Laboratories 001 weight/weight Prescription Only use application Paste for Horses (Ireland) Limited Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 132 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Noromectin Norbrook VPA22664/053/ 0.8 Oral solution - QP54AA01 POM: - Ivermectin Well-established - Oral use Drench 0.8 Laboratories 001 milligram(s)/millil Prescription Only use application mg/ml Oral (Ireland) Limited itre Medicine as (Article 13a of Solution for defined in Directive No Sheep relevant national 2001/82/EC) legislation

Noromectin Multi Norbrook VPA22664/068/ 10 Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous Injection Laboratories 001 milligram(s)/millil injection Prescription Only use (Ireland) Limited itre Medicine as defined in relevant national legislation

Noropraz, 18.7 Norbrook VPA22664/117/ 18.7, 140.3 Oral paste - QP54AA51 POM: - Ivermectin Hybrid - Oral use mg/g + 140.3 Laboratories 001 milligram(s)/gra Prescription Only - Praziquantel application mg/g Oral Paste (Ireland) Limited m Medicine as (Article 13(3) of for Horses defined in Directive No relevant national 2001/82/EC) legislation

Noroseal 2.6 g Norbrook VPA22664/115/ 2.6 g/syringe Intramammary - QG52X LM: Licensed - Bismuth Hybrid - Intramammary Intramammary Laboratories 001 suspension Merchant as subnitrate, heavy application use Suspension for (Ireland) Limited defined in (Article 13(3) of Cattle relevant national Directive No legislation 2001/82/EC)

Norvax compact Intervet Ireland VPA10996/213/ . Emulsion for - QI10AA01 POM: - Salmon Full application - Intraperitoneal PD emulsion for Limited 001 injection Prescription Only pancreas (Article 12(3) of use injection for Medicine as disease virus Directive No Atlantic salmon defined in (spdv) strain f93- 2001/82/EC) relevant national 125 legislation

Novamune CEVA-Phylaxia VPA10463/006/ . Concentrate and - QI01AD09 POM: - Avian infectious Full application - Subcutaneous concentrate and Veterinary 001 solvent for Prescription Only bursal disease (Article 12(3) of use solvent for Biologicals Co. suspension for Medicine as virus, live Directive No suspension for Ltd injection defined in 2001/82/EC) injection for relevant national chickens legislation

Novomate 277.8 Lohmann VPA22931/001/ 277.8 Powder and - QJ01CE90 POM: - Penethamate Hybrid - Intramuscular mg/ml powder Pharma 001 milligram(s)/millil solvent for Prescription Only hydriodide application use and solvent for Herstellung itre suspension for Medicine as (Article 13(3) of suspension for GmbH injection defined in Directive No injection for relevant national 2001/82/EC) cattle legislation

NUFLOR 300 Intervet Ireland VPA10996/268/ 300 Solution for - QJ01BA90 POM: - Florfenicol Full application - Intramuscular mg/ml solution Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use for injection for itre Medicine as Directive No - Subcutaneous cattle and sheep defined in 2001/82/EC) use relevant national legislation

Nuflor 40 mg/g Intervet Ireland VPA10996/238/ 40 Premix for - QJ01BA90 POM: - Florfenicol Full application - Oral use Premix for Limited 001 milligram(s)/gra medicated Prescription Only (Article 12(3) of Medicated m feeding stuff Medicine as Directive No Feeding Stuff for defined in 2001/82/EC) Swine relevant national legislation

Nuflor Minidose Intervet Ireland VPA10996/207/ 450 Solution for - QJ01BA90 POM: - Florfenicol Hybrid - Intramuscular 450 mg/ml Limited 001 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(3) of - Subcutaneous injection for defined in Directive No use cattle relevant national 2001/82/EC) legislation

NUFLOR Swine Intervet Ireland VPA10996/241/ 300 Solution for - QJ01BA90 POM: - Florfenicol Full application - Intramuscular 300 mg/ml Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use Solution for itre Medicine as Directive No injection defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 133 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Nullamec 5 Bimeda Animal VPA22033/066/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Generic - Pour-on use mg/ml pour-on Health Limited 001 milligram(s)/millil Prescription Only application solution for cattle itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

OCNIL 400 mg/g Vetpharma VPA10516/015/ 400 Powder for use - QJ01FF02 POM: - Lincomycin Generic - In drinking powder for use in Animal Health, 001 milligram(s)/gra in drinking water Prescription Only application water use drinking water S.L. m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Octacillin 697 Eurovet Animal VPA10989/051/ 697 Powder for oral - QJ01CA04 POM: - Amoxicillin - Oral use mg/g powder for Health B.V. 001 milligram(s)/gra solution Prescription Only use in drinking m Medicine as water for defined in chickens relevant national legislation

Octacillin 800 Eurovet Animal VPA10989/073/ 800 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - In drinking mg/g powder for Health B.V. 001 milligram(s)/gra in drinking water Prescription Only trihydrate application water use use in drinking m Medicine as (Article 13(1) of water for pigs defined in Directive No relevant national 2001/82/EC) legislation

Oestracton 52.4 Vetoquinol SA VPA10521/003/ 52.4 Solution for - QH01CA01 POM: - Gonadorelin[6- Generic - Intramuscular microgram/ml 001 microgram(s)/mil injection Prescription Only D-phe]acetate application use solution for lilitre Medicine as (Article 13(1) of - Subcutaneous injection for defined in Directive No use cattle, horses, relevant national 2001/82/EC) pigs legislation

Olab Sultrim Old Castle VPA10892/001/ 21 percent Premix for - QJ01EW10 POM: - Trimethoprim Informed - Oral use 21% premix for Laboratories Ltd 001 medicated Prescription Only - Sulfadiazine consent medicated feed feeding stuff Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Omeproshield Boehringer VPA10454/071/ 370 Oral paste - QA02BC01 POM: - Omeprazole Informed - Oral use 370 mg/g oral Ingelheim 001 milligram(s)/gra Prescription Only consent paste for horses Vetmedica m Medicine as application GmbH defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Ophtocycline 10 Le Vet Beheer VPA10475/028/ 10 Eye ointment - QS01AA02 POM: - Generic - Ocular use mg/g eye B.V. 001 milligram(s)/gra Prescription Only Chlortetracycline application ointment for m Medicine as hydrochloride (Article 13(1) of dogs, cats and defined in Directive No horses relevant national 2001/82/EC) legislation

Opticlox Eye Norbrook VPA22664/007/ 16.7 percent Eye ointment - QS01AA90 POM: - Cloxacillin Full application - ZZZ Ointment 16.7% Laboratories 001 weight/weight Prescription Only (Article 12(3) of Conjunctival use w/w (Ireland) Limited Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Optimmune 2 Intervet Ireland VPA10996/242/ 2 Eye ointment - QS01XA90 POM: - Ciclosporin Full application - Ocular use mg/g Eye Limited 001 milligram(s)/gra Prescription Only (Article 12(3) of Ointment m Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 134 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Optomease Vet Virbac S.A. VPA10988/114/ 200 Concentrate for - QN01AX92 POM: - Benzocaine Generic - Water-borne 200 mg/ml 001 milligram(s)/millil solution for fish Prescription Only application use concentrate for itre treatment Medicine as (Article 13(1) of solution for fish defined in Directive No treatment relevant national 2001/82/EC) legislation

Orafluke 10 % Interchem VPA10555/003/ 100, 100 Oral suspension - QP52AC13 POM: - Fenbendazole Informed - Oral use w/v Oral Ireland Ltd 002 milligram(s)/millil Prescription Only - Rafoxanide consent Suspension itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Orafluke 5 % w/v Interchem VPA10555/003/ 50, 50 Oral suspension - QP52AC13 POM: - Fenbendazole Informed - Oral use Oral Suspension Ireland Ltd 001 milligram(s)/millil - QP52AG05 Prescription Only - Rafoxanide consent itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

ORAMEC Boehringer VPA10454/072/ 0.8 Oral solution - QP54AA01 POM: - Ivermectin Full application - Oral use Drench for Ingelheim 001 milligram(s)/millil Prescription Only (Article 12(3) of Sheep 0.8 mg/ml Vetmedica itre Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

Orazole 10% w/v Foran VPA10484/012/ 10 percent Drench - QP52AC13 POM: - Fenbendazole - Oral use Oral Drench Healthcare 001 weight/volume Prescription Only Limited Medicine as defined in relevant national legislation

Orbenin Dry Cow Zoetis Belgium VPA10387/045/ 500 mg/syringe Intramammary - QJ51CF02 POM: - Cloxacillin Full application - Intramammary 500 mg S.A. 001 suspension Prescription Only benzathine (Article 12(3) of use Intramammary Medicine as Directive No Suspension defined in 2001/82/EC) relevant national legislation

Orbenin Extra Zoetis Belgium VPA10387/046/ 600 mg/syringe Intramammary - QJ51CF02 POM: - Cloxacillin Full application - Intramammary Dry Cow 600 mg S.A. 001 suspension Prescription Only benzathine (Article 12(3) of use Intramammary Medicine as Directive No Suspension defined in 2001/82/EC) relevant national legislation

Oridermyl ear ge Vetoquinol VPA10983/040/ . Gel - QS02CA04 POM: - Nystatin Full application - Auricular use Ireland Limited 001 Prescription Only - Triamcinolone (Article 12(3) of Medicine as acetonide Directive No defined in - Permethrin 2001/82/EC) relevant national (25:75) technical legislation - Neomycin sulphate

Orniflox 25 Avimedical B.V. VPA10442/001/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml 001 milligram(s)/millil Prescription Only application concentrate for itre Medicine as (Article 13(1) of oral solution for defined in Directive No pet rabbits, relevant national 2001/82/EC) rodents, legislation ornamental birds and reptiles

Osmonds Dry Bimeda Animal VPA22033/010/ 100, 100, 400 Intramammary - QJ51RC POM: - Neomycin Well-established - Intramammary Cow Health Limited 001 mg/syringe suspension Prescription Only sulphate use application use Intramammary Medicine as - Penethamate (Article 13a of Suspension defined in hydriodide Directive No relevant national - Procaine 2001/82/EC) legislation benzylpenicillin

Veterinary Medicines Authorised/Transfer Pending Products Page 135 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Osmonds ECO Animal VPA22693/017/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin Informed - Topical use Lineout 0.5 % Health Europe 001 Prescription Only consent Pour-on Limited Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Osphos 51 Dechra VPA22622/016/ 51 Solution for - QM05BA02 POM: - Clodronate Full application - Intramuscular mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Prescription Only disodium (Article 12(3) of use for injection for itre Medicine as tetrahydrate Directive No horses defined in 2001/82/EC) relevant national legislation

Osteopen 100 Chanelle VPA10987/131/ 100 Solution for - QM01AX90 VPO: Veterinary - Pentosan Generic - Subcutaneous mg/ml Solution Pharmaceuticals 001 milligram(s)/millil injection Practitioner Only polysulphate application use for injection for Manufacturing itre as defined in sodium (Article 13(1) of dogs Limited relevant national Directive No legislation 2001/82/EC)

Otimectin vet. 1 Le Vet BV VPA10816/016/ 1 Gel - QS02QA03 POM: - Ivermectin Full application - Auricular use mg/g ear gel for 001 milligram(s)/gra Prescription Only (Article 12(3) of cats m Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Otomax Ear Intervet Ireland VPA10996/244/ . international Ear drops, - QS02CA90 POM: - Gentamicin Fixed - Topical use Drops Limited 001 unit(s) suspension Prescription Only - Betamethasone combination Suspension Medicine as - Clotrimazole application defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Otoxolan ear Krka, d.d., Novo VPA10774/047/ 3, 10, 1 Ear drops, - QS02CA06 POM: - Marbofloxacin Generic - Auricular use drops, mesto 001 milligram(s)/millil suspension Prescription Only - Clotrimazole application suspension for itre Medicine as - (Article 13(1) of dogs defined in Dexamethasone Directive No relevant national acetate 2001/82/EC) legislation

Ovarelin 50 Ceva Santé VPA10815/004/ 50 Solution for - QH01CA01 POM: - Gonadorelin Full application - Intramuscular ug/ml, solution Animale 001 microgram(s)/mil injection Prescription Only (Article 12(3) of use for injection for lilitre Medicine as Directive No cattle defined in 2001/82/EC) relevant national legislation

Ovarid Tablets Virbac S.A. VPA10988/081/ 20 mg/tablet Tablet - QG03AC05 POM: - Megestrol - Oral use 20 mg 002 Prescription Only acetate Medicine as defined in relevant national legislation

Ovarid Tablets 5 Virbac S.A. VPA10988/081/ 5 mg/tablet Tablet - QG03AC05 POM: - Megestrol - Oral use mg 001 Prescription Only acetate Medicine as defined in relevant national legislation

Ovimec 0.8 Ancare Ireland VPA10915/012/ 0.8 Oral solution - QP54AA02 POM: - Abamectin Informed - Oral use mg/ml Oral Ltd. 001 milligram(s)/millil Prescription Only consent Solution for itre Medicine as application Sheep defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 136 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Ovimectin 10 Bimeda Animal VPA22033/067/ 10 Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only application use for Injection for itre Medicine as (Article 13(1) of Sheep defined in Directive No relevant national 2001/82/EC) legislation

Ovipast Plus Intervet Ireland VPA10996/147/ 5 x 10^8 cells Suspension for - QI04AB02 LM: Licensed - Mannheimia Full application - Subcutaneous Limited 001 injection Merchant as haemolyticastrai (Article 12(3) of use defined in ns Directive No relevant national - Mannheimia 2001/82/EC) legislation haemolyticastrai ns - Mannheimia haemolyticastrai ns - Mannheimia haemolyticastrai ns - Mannheimia haemolyticastrai ns - Pasteurella trehalosistrains - Pasteurella trehalosistrains - Pasteurella trehalosistrains - Pasteurella trehalosistrains Ovisect 12.5 Bimeda Animal VPA22033/078/ 12.5 Pour-on solution - QP53AC08 POM: - Cypermethrin Generic - Topical use mg/ml Pour-On Health Limited 001 milligram(s)/millil Prescription Only technical high-cis application Solution for itre Medicine as (80:20) (Article 13(1) of Sheep defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 137 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration OVIVAC P PLU Intervet Ireland VPA10996/149/ . Suspension for - QI04AB05 LM: Licensed - Clostridium Immunological - Subcutaneous Limited 001 injection Merchant as perfringens type veterinary use defined in d, strain 603 medicinal relevant national epsilon toxoid product legislation - Clostridium application septicum (Article 13d of s1110/85 toxoid Directive No - Clostridium 2001/82/EC) tetani, strain 51123/91 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 - Formalin killed cells of mannheimia haemolytica serotypes a1 - Formalin killed cells of mannheimia haemolytica serotypes a2 - Formalin killed cells of mannheimia haemolytica serotypes a6 - Formalin killed cells of mannheimia haemolytica serotypes a7 - Formalin killed cells of mannheimia haemolytica serotypes a9 - Formalin killed cells of pasteurella trehalosi serotypes t3 - Formalin killed cells of pasteurella trehalosi serotypes t4 - Formalin killed cells of pasteurella trehalosi serotypes t10 - Formalin pasteurella trehalosi strain t15 (s1105/84)

Oxfencare Oral Ancare Ireland VPA10915/001/ 22.65 Oral suspension - QP52AC02 POM: - Oxfendazole - Oral use Suspension Ltd. 001 milligram(s)/millil Prescription Only itre Medicine as defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 138 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration OXTRA DD 100 FATRO S.p.A. VPA10836/010/ 100 Solution for - QJ01AA06 POM: - Oxytetracycline Generic - Intramuscular mg/ml solution 001 milligram(s)/millil injection Prescription Only hydrochloride application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, sheep, defined in Directive No use pigs, horses, relevant national 2001/82/EC) - Subcutaneous dogs and cats legislation use

Oxycomplex NS Bimeda Animal VPA22033/042/ 100, 20 Solution for - QJ01AA56 POM: - Oxytetracycline ZZZ Informed - Intramuscular Solution for Health Limited 001 milligram(s)/millil injection Prescription Only Hydrochloride consent use Injection itre Medicine as - Flunixin (abridged - Intravenous defined in meglumine application) - use relevant national Council Directive legislation 81/851/EEC

Oxyfluke 34 Norbrook VPA22664/141/ 34 Oral suspension - QP52AG06 POM: - Oxyclozanide Generic - Oral use mg/ml Oral Laboratories 001 milligram(s)/millil Prescription Only application Suspension for (Ireland) Limited itre Medicine as (Article 13(1) of Cattle and defined in Directive No Sheep relevant national 2001/82/EC) legislation

Oxytetracycline Kela n.v. VPA10981/005/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline ZZZ Informed - Intramuscular 20% w/v L.A. 001 milligram(s)/millil injection Prescription Only hydrochloride consent use Solution for itre Medicine as (abridged Injection defined in application) - relevant national Council Directive legislation 81/851/EEC

Oxytetracycline Alfasan VPA10980/001/ 10 percent Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular Injection 10% Nederland B.V 001 weight/volume injection Prescription Only hydrochloride use Medicine as defined in relevant national legislation

Oxytobel 10 Bela-Pharm VPA10445/001/ 10 international Solution for - QH01BB02 POM: - Oxytocin Generic - Intramuscular IU/ml solution for GmbH & Co. KG 001 unit(s)/millilitre injection Prescription Only application use injection for Medicine as (Article 13(1) of - Intravenous Horses, Cattle, defined in Directive No use Pigs, Sheep, relevant national 2001/82/EC) - Subcutaneous Goats, Dogs and legislation use Cats Oxytocin aniMedica VPA10826/004/ 10 international Solution for - QH01BB02 POM: - Oxytocin Well-established - Intramuscular aniMedica GmbH 001 unit(s)/millilitre injection Prescription Only use application use Medicine as (Article 13a of - Subcutaneous defined in Directive No use relevant national 2001/82/EC) legislation

Oxytocin Eurovet Animal VPA10989/044/ 10 international Solution for - QH01BB02 POM: - Oxytocin - Intramuscular Solution for Health B.V. 001 unit(s)/millilitre injection Prescription Only use Injection Medicine as - Intravenous defined in use relevant national legislation

Panacur 10 % Intervet Ireland VPA10996/111/ 10 percent Oral suspension - QP52AC13 POM: - Fenbendazole Full application - Oral use w/v Oral Limited 001 weight/volume Prescription Only (Article 12(3) of Suspension Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Panacur Equine Intervet Ireland VPA10996/113/ 22.2 percent Granules - QP52AC13 POM: - Fenbendazole Full application - Oral use Granules 22.2 % Limited 001 weight/weight Prescription Only (Article 12(3) of w/w Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 139 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Panacur Equine Intervet Ireland VPA10996/118/ 18.75 percent Oral paste - QP52AC13 POM: - Fenbendazole Full application - Oral use Oral Paste 18.75 Limited 001 weight/weight Prescription Only (Article 12(3) of %w/w Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Panacur Intervet Ireland VPA10996/188/ 187.5 Oral paste - QP52AC13 POM: - Fenbendazole Full application - Oral use PetPaste 187.5 Limited 001 milligram(s)/gra Prescription Only (Article 12(3) of mg/g oral paste m Medicine as Directive No for dogs and cat defined in 2001/82/EC) relevant national legislation

Panomec 10 Boehringer VPA10454/073/ 10 Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous mg/ml Solution Ingelheim 001 milligram(s)/millil injection Prescription Only use for Injection for Vetmedica itre Medicine as Cattle, Sheep GmbH defined in and Pigs relevant national legislation

Paracox Intervet Ireland VPA10996/245/ . Suspension for - QI01AN01 POM: - Eimeria Full application - Oral use suspension for Limited 001 oral suspension Prescription Only acervulina hp (Article 12(3) of oral suspension Medicine as - Eimeria brunetti Directive No for chickens defined in hp 2001/82/EC) relevant national - Eimeria legislation maxima cp - Eimeria maxima mfp - Eimeria mitis hp - Eimeria necatrix hp - Eimeria praecox hp - Eimeria tenella hp Paracox-5, Intervet Ireland VPA10996/215/ . Oral suspension - QI01AN01 POM: - Eimeria Full application - Oral use suspension for Limited 001 Prescription Only acervulina hp (Article 12(3) of oral suspension Medicine as - Eimeria Directive No for chickens defined in maxima cp 2001/82/EC) relevant national - Eimeria legislation maxima mfp - Eimeria mitis hp - Eimeria tenella hp Parafend 2.265 Norbrook VPA22664/040/ 2.265 percent Oral suspension - QP52AC02 POM: - Oxfendazole - Oral use % Oral Laboratories 001 weight/volume Prescription Only Suspension (Ireland) Limited Medicine as defined in relevant national legislation

Parafend Plus Norbrook VPA22664/070/ 25/50 Oral suspension - QP52AC52 POM: - Oxfendazole Fixed - Oral use Oral Suspension Laboratories 001 milligram(s)/millil Prescription Only - Closantel combination (Ireland) Limited itre Medicine as application defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Paramectin Norbrook VPA22664/061/ 0.08 percent Oral suspension - QP54AA01 POM: - Ivermectin Well-established - Oral use 0.08% w/v Laboratories 001 weight/volume Prescription Only use application Drench for (Ireland) Limited Medicine as (Article 13a of Sheep defined in Directive No relevant national 2001/82/EC) legislation

Paramectin 0.5 Norbrook VPA22664/066/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin - Topical use % Pour-On Laboratories 001 weight/volume Prescription Only Solution for (Ireland) Limited Medicine as Cattle defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 140 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Paramectin 1% Norbrook VPA22664/065/ 1.0 percent Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous Solution for Laboratories 001 weight/volume injection Prescription Only application use Injection (Ireland) Limited Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Paramove, Solvay VPA10480/001/ 49.5 percent Concentrate for - QD08AX01 POM: - Hydrogen Generic - Cutaneous use 49.5% w/w Chemicals 001 weight/weight solution for fish Prescription Only peroxide application Hydrogen International S.A treatment Medicine as (Article 13(1) of Peroxide defined in Directive No concentrate for relevant national 2001/82/EC) solution for fish legislation treatment Parazole 10% Foran VPA10484/021/ 10 percent Oral suspension - QP52AC13 CAM: - Fenbendazole - Oral use w/v Oral Healthcare 001 weight/volume Companion Suspension Limited Animal Medicine as defined in relevant national legislation

Parazole Foran VPA10484/022/ 100 Suspension for - QP52AC13 CAM: - Fenbendazole Generic - Oral use Dog/Cat 100 Healthcare 001 milligram(s)/millil injection Companion application mg/ml Oral Limited itre Animal Medicine (Article 13(1) of Suspension as defined in Directive No relevant national 2001/82/EC) legislation

Parex 134 mg CF Pharma VPA10515/002/ 134 milligram(s) Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use spot-on solution Limited 002 Merchant as application for medium dogs defined in (Article 13(3) of relevant national Directive No legislation 2001/82/EC)

Parex 268 mg CF Pharma VPA10515/002/ 268 milligram(s) Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use spot-on solution Limited 003 Merchant as application for large dogs defined in (Article 13(3) of relevant national Directive No legislation 2001/82/EC)

Parex 402 mg CF Pharma VPA10515/002/ 402 milligram(s) Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use spot-on solution Limited 004 Merchant as application for very large defined in (Article 13(3) of dogs relevant national Directive No legislation 2001/82/EC)

Parex 50 mg CF Pharma VPA10515/001/ 50 milligram(s) Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use spot-on solution Limited 001 Merchant as application for cats defined in (Article 13(3) of relevant national Directive No legislation 2001/82/EC)

Parex 67 mg CF Pharma VPA10515/002/ 67 milligram(s) Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use spot-on solution Limited 001 Merchant as application for small dogs defined in (Article 13(3) of relevant national Directive No legislation 2001/82/EC)

Parofor 140 Huvepharma NV VPA10782/026/ 140 Oral solution - QA07AA06 POM: - Paromomycin Generic - Oral use mg/ml solution 001 milligram(s)/millil Prescription Only application for use in itre Medicine as (Article 13(1) of drinking water, defined in Directive No milk or milk relevant national 2001/82/EC) replacer for pre- legislation ruminant cattle and pigs Parofor 175 Huvepharma NV VPA10782/031/ 175 Solution for - QJ01GB92 POM: - Paromomycin Generic - Intramuscular mg/ml solution 001 milligram(s)/millil injection Prescription Only sulfate application use for injection for itre Medicine as (Article 13(1) of pigs. defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 141 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Parofor 70000 Huvepharma NV VPA10782/014/ 70000 Powder for use - QA07AA06 POM: - Paromomycin Generic - Oral use IU/g powder for 001 international in drinking water Prescription Only application use in drinking unit(s)/gram Medicine as (Article 13(1) of water, milk or defined in Directive No milk replacer for relevant national 2001/82/EC) pre-ruminant legislation cattle and pigs Parofor crypto Huvepharma NV VPA10782/035/ 140000 Oral solution - QA07AA06 POM: - Paromomycin Full application - Oral use 140 000 IU/ml 001 international Prescription Only (Article 12(3) of oral solution for unit(s)/millilitre Medicine as Directive No pre-ruminant defined in 2001/82/EC) cattle relevant national legislation

Parofor crypto Huvepharma NV VPA10782/033/ 140000 Oral solution - QA07AA06 POM: - Paromomycin Full application - Oral use 140 000 IU/ml 001 international Prescription Only sulfate (Article 12(3) of oral solution for unit(s)/millilitre Medicine as Directive No sheep and goats defined in 2001/82/EC) relevant national legislation

PARVORUVAX Ceva Santé VPA10815/052/ . Suspension for - QI09AL01 LM: Licensed - Porcine Full application - Intramuscular Animale 001 injection Merchant as parvovirus (Article 12(3) of use defined in inactivated k-22 Directive No relevant national strain 2001/82/EC) legislation - Erysipelothrix rhusiopathiae (lysed bacterial cells), serotype 2

PARVOVAX Ceva Santé VPA10815/053/ . Emulsion for - QI09AA02 POM: - Porcine Full application - Intramuscular Animale 001 injection Prescription Only parvovirus (Article 12(3) of use Medicine as inactivated k-22 Directive No defined in strain 2001/82/EC) relevant national legislation

Pathocef 25 Zoetis Belgium VPA10387/047/ 25 Intramammary - QJ51DA32 POM: - Cefoperazone Full application - Intramammary mg/ml S.A. 001 milligram(s)/millil suspension Prescription Only sodium (Article 12(3) of use intramammary itre Medicine as Directive No suspension defined in 2001/82/EC) relevant national legislation

Pen & Strep Norbrook VPA22664/009/ 200, 200 Suspension for - QJ01RA01 POM: - Procaine - Intramuscular Suspension for Laboratories 001 milligram(s)/millil injection Prescription Only benzylpenicillin use Injection (Ireland) Limited itre Medicine as - defined in Dihydrostreptom relevant national ycin sulfate legislation

PEN/STREP Chem-Pharm VPA10823/002/ 200/200 Suspension for - QJ01RA01 POM: - Procaine Informed - Intramuscular Injection 001 milligram(s)/millil injection Prescription Only benzylpenicillin consent use itre Medicine as - application defined in Dihydrostreptom (Article 13c of relevant national ycin Directive No legislation 2001/82/EC)

Penethaone Divasa-Farmavic VPA10505/004/ 236.3 Powder and - QJ01CE90 POM: - Penethamate Generic - Intramuscular 236.3 mg/ml S.A. 001 milligram(s)/millil solvent for Prescription Only hydriodide application use powder and itre suspension for Medicine as - Penethamate (Article 13(1) of solvent for injection defined in hydriodide Directive No suspension for relevant national - Penethamate 2001/82/EC) injection for legislation hydriodide cattle Pen-Strep 20/20 Alfasan VPA10980/009/ 200, 200, 20 Suspension for - QJ01RA01 POM: - Procaine - Intramuscular Suspension for Nederland B.V 001 milligram(s)/millil injection Prescription Only benzylpenicillin use Injection itre Medicine as - Streptomycin defined in sulphate relevant national - Procaine legislation hydrochloride

Veterinary Medicines Authorised/Transfer Pending Products Page 142 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Pentomycin Univet Limited VPA10990/005/ 200, 200 Suspension for - QJ01CE09 POM: - Benzylpenicillin Informed - Intramuscular Suspension for 001 milligram(s)/millil injection Prescription Only procaine consent use Injection itre Medicine as - application defined in Dihydrostreptom (Article 13c of relevant national ycin sulphate Directive No legislation 2001/82/EC)

Peptaleve 370 Norbrook VPA22664/149/ 370 Oral paste - QA02BC01 POM: - Omeprazole Generic - Oral use mg/g Oral Paste Laboratories 001 milligram(s)/gra Prescription Only application for Horses (Ireland) Limited m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Peptizole 370 Norbrook VPA22664/113/ 370 Oral paste - QA02BC01 POM: - Omeprazole Generic - Oral use mg/g Oral Paste Laboratories 001 milligram(s)/gra Prescription Only application for Horses (Ireland) Limited m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Permacyl 236.3 Divasa-Farmavic VPA10505/005/ 236.3 Powder and - QJ01CE90 POM: - Penethamate Generic - Intramuscular mg/ml powder S.A. 001 milligram(s)/millil solvent for Prescription Only hydriodide application use and solvent for itre suspension for Medicine as - Penethamate (Article 13(1) of suspension for injection defined in hydriodide Directive No injection for relevant national - Penethamate 2001/82/EC) cattle legislation hydriodide

PERMAWAY Vetoquinol VPA10983/062/ 600 milligram(s) Intramammary - QJ51CF02 POM: - Cloxacillin Hybrid - Intramammary 600 mg Ireland Limited 001 suspension Prescription Only benzathine application use intramammary Medicine as (Article 13(3) of suspension for defined in Directive No cattle relevant national 2001/82/EC) legislation

Pestigon 134 mg Norbrook VPA22664/095/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 002 Prescription Only application for Medium Dog (Ireland) Limited Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Pestigon 2.5 Norbrook VPA22664/001/ 2.5 Cutaneous - QP53AX15 POM: - Fipronil Generic - Topical use mg/ml Laboratories 001 milligram(s)/millil spray, solution Prescription Only application Cutaneous (Ireland) Limited itre Medicine as (Article 13(1) of Spray, Solution defined in Directive No for Cats and relevant national 2001/82/EC) Dogs legislation

Pestigon 268 mg Norbrook VPA22664/095/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 003 Prescription Only application for large dogs (Ireland) Limited Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Pestigon 402 mg Norbrook VPA22664/095/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 004 Prescription Only application for very large (Ireland) Limited Medicine as (Article 13(3) of dogs defined in Directive No relevant national 2001/82/EC) legislation

Pestigon 50 mg Norbrook VPA22664/098/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 001 Prescription Only application for Cats (Ireland) Limited Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 143 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Pestigon 67 mg Norbrook VPA22664/095/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-On Solution Laboratories 001 Prescription Only application for Small Dogs (Ireland) Limited Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

PestiGon Combo Norbrook VPA22664/135/ 134, 120.6 Spot-on solution - QP53AX65 POM: - Fipronil Generic - Topical use 134 mg / 120.6 Laboratories 002 mg/pipette Prescription Only - (S)-methoprene application mg spot-on (Ireland) Limited Medicine as (Article 13(1) of solution for defined in Directive No medium dogs relevant national 2001/82/EC) legislation

PestiGon Combo Norbrook VPA22664/135/ 268, 241.2 Spot-on solution - QP53AX65 POM: - Fipronil Generic - Topical use 268 mg / 241.2 Laboratories 003 mg/pipette Prescription Only - (S)-methoprene application mg spot-on (Ireland) Limited Medicine as (Article 13(1) of solution for large defined in Directive No dogs relevant national 2001/82/EC) legislation

PestiGon Combo Norbrook VPA22664/135/ 402, 361.8 Spot-on solution - QP53AX65 POM: - Fipronil Generic - Topical use 402 mg / 361.8 Laboratories 004 mg/pipette Prescription Only - (S)-methoprene application mg spot-on (Ireland) Limited Medicine as (Article 13(1) of solution for very defined in Directive No large dogs relevant national 2001/82/EC) legislation

PestiGon Combo Norbrook VPA22664/131/ 50, 60 Spot-on solution - QP53AX65 POM: - Fipronil Generic - Topical use 50 mg / 60 mg Laboratories 001 mg/pipette Prescription Only - (S)-methoprene application spot-on solution (Ireland) Limited Medicine as (Article 13(1) of for cats and defined in Directive No ferrets relevant national 2001/82/EC) legislation

PestiGon Combo Norbrook VPA22664/135/ 67, 60.3 Spot-on solution - QP53AX65 POM: - Fipronil Generic - Topical use 67 mg / 60.3 mg Laboratories 001 mg/pipette Prescription Only - (S)-methoprene application spot-on solution (Ireland) Limited Medicine as (Article 13(1) of for small dogs defined in Directive No relevant national 2001/82/EC) legislation

PG 600 Powder Intervet Ireland VPA10996/025/ 600 international Powder and - QG03GA99 POM: - Gonadotrophin Full application - Intramuscular and solvent for Limited 001 unit(s) solvent for Prescription Only equine serum (Article 12(3) of use solution for solution for Medicine as - Gonadotrophin Directive No injection injection defined in chorionic 2001/82/EC) relevant national legislation

PGF Veyx Veyx-Pharma VPA10539/002/ 0.0875 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular 0.0875 mg/ml GmbH 001 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle and pigs relevant national 2001/82/EC) legislation

PGF Veyx forte Veyx-Pharma VPA10539/002/ 0.250 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular 0.250 mg/ml GmbH 002 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle and pigs relevant national 2001/82/EC) legislation

Pharmacillin 300 Chem-Pharm VPA10823/001/ 300 Suspension for - QJ01CE09 POM: - Procaine Informed - Intramuscular mg/ml 001 milligram(s)/millil injection Prescription Only benzylpenicillin consent use suspension for itre Medicine as application injection defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 144 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Pharmasin 100 Huvepharma NV VPA10782/012/ 100 percent Granules for use - QJ01FA90 POM: - Tylosin Tartrate Generic - Oral use % w/w Granules 001 weight/weight in drinking water Prescription Only application for Use in Medicine as (Article 13(1) of Drinking Water defined in Directive No for Pigs, relevant national 2001/82/EC) Chickens, legislation Turkeys and Calves Pharmasin 100 Huvepharma NV VPA10782/006/ 100,000 Premix for - QJ01FA90 POM: - Tylosin Generic - Oral use 000 IU/g Premix 002 international medicated Prescription Only application for medicated unit(s)/gram feeding stuff Medicine as (Article 13(1) of feeding stuff for defined in Directive No pigs, broilers and relevant national 2001/82/EC) pullets legislation

Pharmasin 20 Huvepharma NV VPA10782/001/ 20,000 Granules - QJ01FA90 POM: - Tylosin Generic - Oral use 000 IU/g Oral 002 international Prescription Only application Granules for pig unit(s)/gram Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Pharmasin 200 Huvepharma NV VPA10782/015/ 200,000 Solution for - QJ01FA90 POM: - Tylosin Generic - Intramuscular mg/ml solution 001 international injection Prescription Only application use for injection for unit(s)/millilitre Medicine as (Article 13(1) of - Intravenous cattle, sheep, defined in Directive No use goats and pigs relevant national 2001/82/EC) legislation

Pharmasin 250 Huvepharma NV VPA10782/006/ 250,000 Premix for - QJ01FA90 POM: - Tylosin (base) Generic - Oral use 000 IU/g Premix 003 international medicated Prescription Only application for medicated unit(s)/gram feeding stuff Medicine as (Article 13(1) of feeding stuff for defined in Directive No pigs, broilers and relevant national 2001/82/EC) pullets legislation

Pharmazan C Chem-Pharm VPA10823/020/ 1.5, 3.0
Oral suspension - QP52AE51 POM: - Levamisole Informed - Oral use Oral Suspension 001 percent Prescription Only hydrochloride consent for Sheep and weight/volume Medicine as - Oxyclozanide application Cattle defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Phenocillin 800 Eurovet Animal VPA10989/065/ 800 Powder for use - QJ01CE02 POM: - Hybrid - Oral use mg/g powder for Health B.V. 001 milligram(s)/gra in drinking water Prescription Only Phenoxymethyl application use in drinking m Medicine as penicillin (Article 13(3) of water for defined in potassium Directive No chickens relevant national 2001/82/EC) legislation

Phenoleptil 100 Le Vet BV VPA10816/012/ 100 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use mg Tablets for 004 Prescription Only application dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Phenoleptil 12.5 Le Vet BV VPA10816/012/ 12.5 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use mg tablets for 001 Prescription Only application dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Phenoleptil 25 Le Vet BV VPA10816/012/ 25 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use mg Tablets for 003 Prescription Only application dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 145 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Phenoleptil 50 Le Vet BV VPA10816/012/ 50 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use mg tablets for 002 Prescription Only application dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Phenotab CP-Pharma VPA10810/019/ 100 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Generic - Oral use Flavoured 100 Handelsgesellsc 003 Prescription Only application mg Tablets for haft mbH Medicine as (Article 13(1) of dogs defined in Directive No relevant national 2001/82/EC) legislation

Phenotab CP-Pharma VPA10810/019/ 25 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use Flavoured 25 mg Handelsgesellsc 001 Prescription Only application Tablets for dogs haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Phenotab CP-Pharma VPA10810/019/ 60 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use Flavoured 60 mg Handelsgesellsc 002 Prescription Only application Tablets for dogs haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Phenovet 60 mg Domes Pharma VPA10386/003/ 60 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Generic - Oral use tablets for dogs SC 001 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Phenoxypen Dopharma VPA10791/001/ 325 Powder for oral - QJ01CE02 POM: - Full application - Oral use Water Soluble Research B.V. 001 milligram(s)/gra solution Prescription Only Phenoxymethyl (Article 12(3) of Powder, 325 m Medicine as penicillin Directive No mg/g powder for defined in 2001/82/EC) oral solution for relevant national chickens legislation

Phenylarthrite Vetoquinol VPA10983/013/ 20 percent Solution for - QM01AA01 POM: - Full application - Intramuscular solution for Ireland Limited 001 weight/volume injection Prescription Only Phenylbutazone (Article 12(3) of use injection Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national legislation

Pigfen 200 Huvepharma NV VPA10782/029/ 200 Suspension for - QP52AC13 POM: - Fenbendazole Hybrid - In drinking mg/ml 001 milligram(s)/millil use in drinking Prescription Only application water use suspension for itre water Medicine as (Article 13(3) of use in drinking defined in Directive No water for pigs relevant national 2001/82/EC) legislation

Pigfen 40 mg/g Huvepharma NV VPA10782/019/ 40 Granules - QP52AC13 POM: - Fenbendazole Well-established - Oral use granules for pigs 001 milligram(s)/gra Prescription Only use application m Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Pigfen 40 mg/g Huvepharma NV VPA10782/021/ 40 Premix for - QP52AC13 POM: - Fenbendazole Hybrid - Oral use premix for 001 milligram(s)/gra medicated Prescription Only application medicated m feeding stuff Medicine as (Article 13(3) of feeding stuff for defined in Directive No pigs relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 146 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Pigzin Premix, DSM Nutritional VPA10443/001/ 100 percent Premix for - QA07XA91 POM: - Zinc oxide Full application - Oral use 100% w/w Products (UK) 001 weight/weight medicated Prescription Only (Article 12(3) of Premix for Ltd feeding stuff Medicine as Directive No medicated defined in 2001/82/EC) feeding stuff relevant national legislation

Pimocard 1.25 Eurovet Animal VPA10989/067/ 1.25 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use mg flavoured Health B.V. 001 Prescription Only application tablets for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Pimocard 10 mg Eurovet Animal VPA10989/067/ 10 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use flavoured tablets Health B.V. 004 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Pimocard 2.5 mg Eurovet Animal VPA10989/067/ 2.5 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use flavoured tablets Health B.V. 002 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Pimocard 5 mg Eurovet Animal VPA10989/067/ 5 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use flavoured tablets Health B.V. 003 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Pimotab 1.25 mg CP-Pharma VPA10810/018/ 1.25 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Per Oral chewable tablets Handelsgesellsc 001 Prescription Only application for dogs haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Pimotab 10 mg CP-Pharma VPA10810/018/ 10 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Per Oral chewable tablets Handelsgesellsc 004 Prescription Only application for dogs haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Pimotab 15 mg CP-Pharma VPA10810/018/ 15 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Per Oral chewable tablets Handelsgesellsc 005 Prescription Only application for dogs haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Pimotab 2.5 mg CP-Pharma VPA10810/018/ 2.5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Per Oral chewable tablets Handelsgesellsc 002 Prescription Only application for dogs haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Pimotab 5 mg CP-Pharma VPA10810/018/ 5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Per Oral chewable tablets Handelsgesellsc 003 Prescription Only application for dogs haft mbH Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 147 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration PIRESOL 300 SP Veterinaria, VPA10790/014/ 300 Solution for use - QN02BE01 POM: - Hybrid - In drinking mg/ml solution S.A. 001 milligram(s)/millil in drinking water Prescription Only PARACETAMOL application water use for use in itre Medicine as (Article 13(3) of drinking water for defined in Directive No pigs relevant national 2001/82/EC) legislation

PIRETAMOL GLOBAL VET VPA10477/003/ 300 Oral solution - QN02BE01 POM: - Paracetamol Full application - In drinking 300 mg/ml HEALTH SL 001 milligram(s)/millil Prescription Only (Article 12(3) of water use solution for use itre Medicine as Directive No in drinking water defined in 2001/82/EC) for pigs relevant national legislation

Planate 0.0875 Intervet Ireland VPA10996/246/ 0.0875 Solution for - QG02AD90 POM: - Cloprostenol Full application - Intramuscular mg/ml Solution Limited 001 milligram(s)/millil injection Prescription Only sodium (Article 12(3) of use for injection itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Planipart Boehringer VPA10454/017/ 30 Solution for - QG02CA91 VPO: Veterinary - Clenbuterol Full application - Intravenous Solution for Ingelheim 001 microgram(s)/mil injection Practitioner Only hydrochloride (Article 12(3) of use Injection 30 Vetmedica lilitre as defined in Directive No microgram/ml GmbH relevant national 2001/82/EC) legislation

Plenix LC 75 mg, Ceva Santé VPA10815/044/ 75 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Generic - Intramammary intramammary Animale 001 ointment Prescription Only application use ointment for Medicine as (Article 13(1) of lactating cows defined in Directive No relevant national 2001/82/EC) legislation

Ploff LHV Bonapp HOVR10466/00 . Oral solution LM: Licensed - Actaea Simplified - Oral use 5/001 Merchant as racemose Registration of a defined in - Euphrasia Veterinary relevant national officinalis Homeopathic legislation - Echinacea Medicinal angustifolia Product (Article 16, Directive 2001/82/EC) Pluset powder LABORATORIO VPA10665/001/ 50/50 Powder and - QG03GA POM: - Follicle Full application - Intramuscular and solvent for S CALIER S.A. 001 international solvent for Prescription Only stimulating (Article 12(3) of use solution for unit(s)/millilitre solution for Medicine as hormone (fshp) Directive No injection injection defined in - Luteinizing 2001/82/EC) relevant national hormone (lhp) legislation - Follicle stimulating hormone (fshp) - Luteinizing hormone (lhp) Pneumovac Plus Animal Health VPA22715/002/ . relative Suspension for - QI02AL04 POM (E): - Bovine Full application - Subcutaneous suspension for Distributors 001 potency/dose injection Prescription Only respiratory (Article 12(3) of use injection for Limited Exempt as syncytial virus, Directive No cattle defined in strain bio-24, 2001/82/EC) relevant national inactivated legislation - Bovine parainfluenza 3 virus, strain bio- 23, inactivated - Mannheimia Haemolytica, serotype A1 strain dsm 5283, inactivated - Bovine Viral Diarrhoea Virus, Strain Bio-25, Inactavited

Veterinary Medicines Authorised/Transfer Pending Products Page 148 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Pneumovac Animal Health VPA22715/001/

virus, strain bio- relative 23, inactivated potency/dose - Mannheimia Haemolytica, serotype A1 strain dsm 5283, inactivated

PolyVar Yellow Elanco GmbH VPA22020/058/ 275 Bee-hive strip - QP53AC05 LM: Licensed - Flumethrin Full application - Topical use 275 mg bee-hive 001 milligram/strip Merchant as (Article 12(3) of strip defined in Directive No relevant national 2001/82/EC) legislation

Porcilis APP Intervet Ireland VPA10996/100/ . Suspension for - QI09AB07 POM (E): - Concentrate of Full application - Intramuscular suspension for Limited 001 injection Prescription Only actinobacillus (Article 12(3) of use injection for pigs Exempt as pleuropneumoni Directive No defined in ae antigens 2001/82/EC) relevant national containing legislation - Omp (outer membrane protein) - Apxi (105 kilodalton type i toxoid) - Apxii (105 kilodalton type ii toxoid) - Apxiii (120 kilodalton macrophage toxoid) Porcilis Ery + Intervet Ireland VPA10996/097/ . Suspension for - QI09AL01 LM: Licensed - Inactivated Immunological - Intramuscular Parvo Limited 001 injection Merchant as porcine veterinary use suspension for defined in parvovirus strain medicinal injection for pigs relevant national 014 product legislation - Inactivated application erysipelothrix (Article 13d of rhusiopathiae Directive No strain M2 2001/82/EC) (Serotype 2) Porcilis ERY Intervet Ireland VPA10996/096/ . Suspension for - QI09AB LM: Licensed - Erysipelothrix Full application - Intramuscular suspension for Limited 001 injection Merchant as rhusiopathiae (Article 12(3) of use injection for pigs defined in strain m2 Directive No relevant national (serotype 2) 2001/82/EC) legislation

Porcilis Intervet Ireland VPA10996/279/ . Suspension for - QI09AL07 LM: Licensed - E.rhusiopathiae Full application - Intramuscular Ery+Parvo+Lept Limited 001 injection Merchant as strain m2 (Article 12(3) of use o suspension for defined in - Porcine parvo Directive No injection for pigs relevant national virus 2001/82/EC) legislation - Leptospira canicola - Leptospira icterohaemorrha giae - Leptospira australis - Leptospira grippotyphosa - Leptospira pomona - Leptospira tarassovi

Veterinary Medicines Authorised/Transfer Pending Products Page 149 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Porcilis Glässer Intervet Ireland VPA10996/179/ . enzyme-linked Suspension for - QI09AB07 POM: - Inactivated Full application - Intramuscular Suspension for Limited 001 immunosorbent injection Prescription Only whole cells of (Article 12(3) of use injection for pigs assay unit/dose Medicine as Haemophilis Directive No defined in parasuis 2001/82/EC) relevant national serotype 5, strain legislation 4800

Porcilis Intervet Ireland VPA10996/280/ . Lyophilisate and - QI09AB POM: - Lawsonia Full application - Intradermal use Lawsonia ID Limited 001 solvent for Prescription Only intracellularis (Article 12(3) of lyophilisate and suspension for Medicine as strain spah-08 Directive No solvent for injection defined in inactivated 2001/82/EC) emulsion for relevant national injection for pigs legislation

Porcilis Intervet Ireland VPA10996/278/ . Lyophilisate and - QI09AB POM: - Inactivated Full application - Intramuscular Lawsonia Limited 001 solvent for Prescription Only Lawsonia (Article 12(3) of use lyophilisate and emulsion for Medicine as intracellularis Directive No solvent for injection defined in strain SPAH-08 2001/82/EC) emulsion for relevant national injection for pigs legislation

Porcilis M Hyo ID Intervet Ireland VPA10996/264/ . Emulsion for - QI09AB13 POM: - Inactivated Full application - Intradermal use ONCE emulsion Limited 001 injection Prescription Only whole cell (Article 12(3) of for injection for Medicine as concentrate of Directive No pigs defined in m. 2001/82/EC) relevant national hyopneumoniae legislation strain 11

Porcilis M Hyo, Intervet Ireland VPA10996/196/ . Suspension for - QI09AB13 POM: - Mycoplasma Full application - Intramuscular suspension for Limited 001 injection Prescription Only hyopneumoniae (Article 12(3) of use injection Medicine as strain 11 Directive No defined in inactivated whole 2001/82/EC) relevant national cell concentrate legislation

Porcilis Parvo Intervet Ireland VPA10996/098/ . Suspension for - QI09AA02 LM: Licensed - Inactivated Full application - Intramuscular Limited 001 injection Merchant as porcine (Article 12(3) of use defined in parvovirus strain Directive No relevant national 014 2001/82/EC) legislation

Porcilis PRRS Intervet Ireland VPA10996/128/ . Lyophilisate and - QI09AD03 POM: - Porcine Full application - Intradermal use lyophilisate and Limited 001 solvent for Prescription Only reproductive (Article 12(3) of - Intramuscular solvent for suspension for Medicine as respiratory Directive No use suspension for injection defined in syndrome (prrs) 2001/82/EC) injection for pigs relevant national virus strain dv legislation live

Porcimec 10 Bimeda Animal VPA22033/052/ 10 Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous mg/ml solution Health Limited 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of pigs defined in Directive No relevant national 2001/82/EC) legislation

Porcimectin 1%, Bimeda Animal VPA22033/053/ 1.0 percent Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous Solution for Health Limited 001 weight/volume injection Prescription Only application use Injection for pigs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Poulvac Bursa Zoetis Belgium VPA10387/049/ . Lyophilisate for - QI01AD09 POM: - Live infectious Full application - Oral use Plus Lyophilisate S.A. 001 suspension Prescription Only bursal disease (Article 12(3) of for suspension in Medicine as virus, strain Directive No drinking water defined in V877 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 150 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Poulvac Bursine Zoetis Belgium VPA10387/091/ tissue culture Lyophilisate for - QI01AD09 POM: - Infectious Full application - In drinking 2 lyophilisate for S.A. 001 infective dose suspension Prescription Only bursal disease (Article 12(3) of water use suspension for 50/dose Medicine as virus strain lukert Directive No - ZZZ Spray spray defined in 2001/82/EC) vaccination or for relevant national use in drinking legislation water for chickens

Poulvac IB QX Zoetis Belgium VPA10387/051/ . 50% Embryo Lyophilisate for - QI01AD07 POM: - Live attenuated Full application - ZZZ Spray lyophilisate for S.A. 001 Infective suspension for Prescription Only avian infectious (Article 12(3) of suspension for Dose/dose spray Medicine as bronchitis virus Directive No spray for administration defined in strain L1148 2001/82/EC) chickens relevant national legislation

POULVAC IBMM Zoetis Belgium VPA10387/053/ . Lyophilisate for - QI01AD07 POM: - Avian infectious Full application - Oral use + ARK S.A. 001 suspension for Prescription Only bronchitis virus (Article 12(3) of Lyophilisate for spray Medicine as strain Directive No suspension for administration defined in massachusetts 2001/82/EC) spray relevant national 1263 administration for legislation - Avian infectious chickens bronchitis virus strain arkansas 3168

Powdox Vetpharma VPA10516/006/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Generic - In drinking Doxycycline 500 Animal Health, 001 milligram(s)/gra in drinking water Prescription Only application water use mg/g powder for S.L. m Medicine as (Article 13(1) of use in drinking defined in Directive No water for pigs, relevant national 2001/82/EC) chickens and legislation turkeys

Prascend 1 mg Boehringer VPA10454/011/ 1 mg/tablet Tablet - QN04BC02 POM: - Pergolide Full application - Oral use tablets for horse Ingelheim 001 Prescription Only (Article 12(3) of Vetmedica Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

Prazitel 230/20 Chanelle VPA10987/101/ 230, 20 Film-coated - QP52AA51 CAM: - Praziquantel Hybrid - Oral use mg Flavoured Pharmaceuticals 001 mg/tablet tablet Companion - Pyrantel application Film-Coated Manufacturing Animal Medicine embonate (Article 13(3) of Tablets for Cats Limited as defined in Directive No relevant national 2001/82/EC) legislation

Prazitel Plus Chanelle VPA10987/076/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use Tablets for Dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application Manufacturing Animal Medicine embonate (Article 10(3) of Limited as defined in - Febantel Directive No relevant national 2001/83/EC) legislation

Prazitel Plus XL Chanelle VPA10987/076/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of Limited as defined in - Febantel Directive No relevant national 2001/82/EC) legislation

Prazpronto 20mg Chanelle VPA10987/165/ 20 mg/pipette Spot-on solution - QP52AA01 CAM: - Praziquantel Generic - Spot-on use Spot-on solution Pharmaceuticals 001 Companion application for small Cats Manufacturing Animal Medicine (Article 13(1) of and Kittens Limited as defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 151 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Prazpronto 40 Chanelle VPA10987/165/ 40 milligram(s) Spot-on solution - QP52AA01 CAM: - Praziquantel Generic - Spot-on use mg Spot-on Pharmaceuticals 002 Companion application solution for Manufacturing Animal Medicine (Article 13(1) of medium cats Limited as defined in Directive No relevant national 2001/82/EC) legislation

Prazpronto 60 Chanelle VPA10987/165/ 60 milligram(s) Spot-on solution - QP52AA01 CAM: - Praziquantel Generic - Spot-on use mg Spot-on Pharmaceuticals 003 Companion application solution for large Manufacturing Animal Medicine (Article 13(1) of cats Limited as defined in Directive No relevant national 2001/82/EC) legislation

Prednicortone 20 Le Vet Beheer VPA10475/018/ 20 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Generic - Oral use mg tablets for B.V. 002 Prescription Only application dogs and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Prednicortone 5 Le Vet Beheer VPA10475/018/ 5 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Generic - Oral use mg tablets for B.V. 001 Prescription Only application dogs and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

PREVENDOG Vetpharma VPA10516/021/ 0.636 Medicated collar - QP53AC11 CAM: - Deltamethrin Hybrid - Cutaneous use 0.636 g Animal Health, 001 gram(s)/collar Companion application medicated collar S.L. Animal Medicine (Article 13(3) of for very small as defined in Directive No dogs relevant national 2001/82/EC) legislation

PREVENDOG Vetpharma VPA10516/021/ 1.056 Medicated collar - QP53AC11 CAM: - Deltamethrin Hybrid - Cutaneous use 1.056 g Animal Health, 002 gram(s)/collar Companion application medicated collar S.L. Animal Medicine (Article 13(3) of for small to as defined in Directive No medium dogs relevant national 2001/82/EC) legislation

PREVENDOG Vetpharma VPA10516/021/ 1.304 Medicated collar - QP53AC11 CAM: - Deltamethrin Hybrid - Cutaneous use 1.304 g Animal Health, 003 gram(s)/collar Companion application medicated collar S.L. Animal Medicine (Article 13(3) of for large to very as defined in Directive No large dogs relevant national 2001/82/EC) legislation

Previron 200 Laboratorios VPA10846/015/ 200 Solution for - QB03AC LM: Licensed - Gleptoferron Well-established - Intramuscular mg/ml solution Hipra S.A. 001 milligram(s)/millil injection Merchant as use application use for injection for itre defined in (Article 13a of pigs relevant national Directive No legislation 2001/82/EC)

Prid delta 1.55 g Ceva Santé VPA10815/013/ 1.55 gram(s) Vaginal delivery - QG03DA04 VPO: Veterinary - Progesterone Generic - Vaginal use vaginal delivery Animale 001 system Practitioner Only application system for cattle as defined in (Article 13(1) of relevant national Directive No legislation 2001/82/EC)

PRID E 1.55 g LAPROVET VPA10483/001/ 1.55 gram(s) Vaginal delivery - QG03DA04 POM: - Progesterone Generic - Vaginal use vaginal delivery 001 system Prescription Only application system for cattle Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 152 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Prilactone Next Ceva Santé VPA10815/035/ 10 mg/tablet Chewable tablet - QC03DA01 POM: - Spironolactone Full application - Oral use 10 mg chewable Animale 001 Prescription Only (Article 12(3) of tablets for dogs Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Prilactone Next Ceva Santé VPA10815/035/ 100 mg/tablet Chewable tablet - QC03DA01 POM: - Spironolactone Full application - Oral use 100 mg Animale 003 Prescription Only (Article 12(3) of chewable tablets Medicine as Directive No for dogs defined in 2001/82/EC) relevant national legislation

Prilactone Next Ceva Santé VPA10815/035/ 50 mg/tablet Chewable tablet - QC03DA01 POM: - Spironolactone Full application - Oral use 50 mg chewable Animale 002 Prescription Only (Article 12(3) of tablets for dogs Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Primectin 0.5% Norbrook VPA22664/078/ 0.5 percent Pour-on solution - QP54AA01 POM: - Ivermectin Informed - Topical use w/v Pour-On Laboratories 001 weight/volume Prescription Only consent Solution (Ireland) Limited Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Primidoxine Norbrook VPA22664/022/ 40, 200 Solution for - QJ01EW13 POM: - Trimethoprim - Intramuscular Solution for Laboratories 001 milligram(s)/millil injection Prescription Only - Sulfadoxine use Injection (Ireland) Limited itre Medicine as - Intravenous defined in use relevant national - Subcutaneous legislation use

PRIMOPEN 300 FATRO S.p.A. VPA10836/007/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin Hybrid - Intramuscular mg/ml 001 milligram(s)/millil injection Prescription Only (procaine) application use suspension for itre Medicine as monohydrate (Article 13(3) of injection for defined in Directive No cattle, pigs and relevant national 2001/82/EC) horses legislation

Prinocate 100 Krka, d.d., Novo VPA10774/070/ 100,25 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/25 mg spot- mesto 002 mg/pipette Prescription Only - Moxidectin application on solution for Medicine as (Article 13(3) of medium dogs defined in Directive No relevant national 2001/82/EC) legislation

Prinocate 250 Krka, d.d., Novo VPA10774/070/ 250,62.5 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/62.5 mg mesto 003 mg/pipette Prescription Only - Moxidectin application spot-on solution Medicine as (Article 13(3) of for large dogs defined in Directive No relevant national 2001/82/EC) legislation

Prinocate 40 Krka, d.d., Novo VPA10774/070/ 40,10 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/10 mg spot- mesto 001 Prescription Only - Moxidectin application on solution for Medicine as (Article 13(3) of small dogs defined in Directive No relevant national 2001/82/EC) legislation

Prinocate 40 Krka, d.d., Novo VPA10774/068/ 40,4 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/4 mg spot-on mesto 001 Prescription Only - Moxidectin application solution for small Medicine as (Article 13(3) of cats and ferrets defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 153 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Prinocate 400 Krka, d.d., Novo VPA10774/070/ 400,100 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/100 mg spot- mesto 004 mg/pipette Prescription Only - Moxidectin application on solution for Medicine as (Article 13(3) of extra-large dogs defined in Directive No relevant national 2001/82/EC) legislation

Prinocate 80 Krka, d.d., Novo VPA10774/069/ 80,8 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use mg/8 mg spot-on mesto 001 Prescription Only - Moxidectin application solution for large Medicine as (Article 13(3) of cats defined in Directive No relevant national 2001/82/EC) legislation

Prinovox 100 mg Elanco GmbH VPA22020/057/ 100 + 25 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use + 25 mg spot-on 002 mg/pipette Prescription Only - Moxidectin application solution for Medicine as (Article 13(1) of medium dogs defined in Directive No relevant national 2001/82/EC) legislation

Prinovox 250 mg Elanco GmbH VPA22020/057/ 250 + 62.5 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use + 62.5 mg spot- 003 mg/pipette Prescription Only - Moxidectin application on solution for Medicine as (Article 13(1) of large dogs defined in Directive No relevant national 2001/82/EC) legislation

Prinovox 40 mg Elanco GmbH VPA22020/057/ 40 + 10 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use + 10 mg spot-on 001 mg/pipette Prescription Only - Moxidectin application solution for small Medicine as (Article 13(1) of dogs. defined in Directive No relevant national 2001/82/EC) legislation

Prinovox 40 mg Elanco GmbH VPA22020/056/ 40 + 4 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use + 4 mg spot-on 001 mg/pipette Prescription Only - Moxidectin application solution for small Medicine as (Article 13(1) of cats and ferrets defined in Directive No relevant national 2001/82/EC) legislation

Prinovox 400 mg Elanco GmbH VPA22020/057/ 400 + 100 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use + 100 mg spot- 004 mg/pipette Prescription Only - Moxidectin application on solution for Medicine as (Article 13(1) of extra-large dogs defined in Directive No relevant national 2001/82/EC) legislation

Prinovox 80 mg Elanco GmbH VPA22020/056/ 80 + 8 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use + 8 mg spot-on 002 mg/pipette Prescription Only - Moxidectin application solution for large Medicine as (Article 13(1) of cats defined in Directive No relevant national 2001/82/EC) legislation

Pro Penstrep Interchem VPA10555/007/ 200, 200 Suspension for - QJ01RA01 POM: - Benzylpenicillin Informed - Intramuscular Suspension for Ireland Ltd 001 milligram(s)/millil injection Prescription Only procaine (lecithin consent use Injection for itre Medicine as coated 1%) application Cattle, Sheep defined in - (Article 13c of and Pigs relevant national Dihydrostreptom Directive No legislation ycin (as the 2001/82/EC) sulfate)

Proactive 0.15 DeLaval NV VPA10827/001/ 0.15 percent Teat dip/spray - QD08AG03 LM: Licensed - Available Full application - Dipping %w/w Teat 001 weight/weight solution Merchant as iodine, ph. eur. (Article 12(3) of - ZZZ Spray Dip/Spray defined in (as Directive No Solution relevant national iodine/sodium 2001/82/EC) legislation iodide/poloxamer complex 0.86)

Veterinary Medicines Authorised/Transfer Pending Products Page 154 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration PROBENCIL MEVET S.A.U. VPA22009/001/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin Generic - Intramuscular 300 mg/ml 001 milligram(s)/millil injection Prescription Only procaine application use suspension for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle and pigs relevant national 2001/82/EC) legislation

Procactive 300 Laboratorios VPA10495/006/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin Generic - Intramuscular mg/ml SYVA, S.A.U 001 milligram(s)/millil injection Prescription Only Procaine application use Suspension for itre Medicine as Monohydrate (Article 13(1) of injection for defined in Directive No cattle and pigs relevant national 2001/82/EC) legislation

Procamidor Duo Richter Pharma VPA10801/014/ 40, 0.036 Solution for - QN01BA52 VPO: Veterinary - Procaine Generic - Perineural use 40 mg/ml + AG 001 milligram(s)/millil injection Practitioner Only hydrochloride application - Subcutaneous 0.036 mg/ml itre as defined in - Adrenaline (Article 13(1) of use solution for relevant national tartrate Directive No injection legislation 2001/82/EC)

Procapen aniMedica VPA10826/019/ 3 g/syringe Intramammary - QJ51CE09 POM: - Procaine Generic - Intramammary Injector 3 g GmbH 001 suspension Prescription Only benzylpenicillin application use intramammary Medicine as (Article 13(1) of suspension for defined in Directive No cattle relevant national 2001/82/EC) legislation

Procillin 300 Bimeda Animal VPA22033/043/ 300 Suspension for - QJ01CE09 POM: - Procaine - Intramuscular mg/ml Health Limited 001 milligram(s)/millil injection Prescription Only benzylpenicillin use Suspension for itre Medicine as Injection for defined in Cattle, Sheep relevant national and Pigs legislation

Procipen 300 Bimeda Animal VPA22033/075/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin Generic - Intramuscular mg/ml Health Limited 001 milligram(s)/millil injection Prescription Only procaine application use suspension for itre Medicine as (Article 13(1) of injection for defined in Directive No cattle, sheep and relevant national 2001/82/EC) pigs legislation

Procycline LA Interchem VPA10555/008/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular 200 mg/ml Ireland Ltd 001 milligram(s)/millil injection Prescription Only consent use solution for itre Medicine as application injection defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Pro-Dynam Oral Dechra VPA10803/001/ 1.0 g/sachet Oral powder - QM01AA01 POM: - Full application - Oral use Powder 1 g Veterinary 001 Prescription Only Phenylbutazone (Article 12(3) of phenylbutazone Products A/S Medicine as Directive No per sachet defined in 2001/82/EC) relevant national legislation

Progressis Ceva Santé VPA10815/054/ . Emulsion for - QI09AA05 POM: - Inactivated Full application - Intramuscular Emulsion for Animale 001 injection Prescription Only porcine (Article 12(3) of use injection for pigs Medicine as reproductive and Directive No (sows and gilts) defined in respiratory 2001/82/EC) relevant national syndrome (prrs) legislation virus, p120 strain

Proin 15 mg Pegasus VPA22713/001/ 15 mg/tablet Chewable tablet - QG04BX91 POM: - Hybrid - Oral use chewable tablets Laboratories 001 Prescription Only Phenylpropanol application for dogs Ireland Limited Medicine as amine (Article 13(3) of defined in hydrochloride Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 155 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Proin 50 mg Pegasus VPA22713/001/ 50 mg/tablet Tablet - QG04BX91 POM: - Hybrid - Oral use chewable tablets Laboratories 002 Prescription Only Phenylpropanol application for dogs Ireland Limited Medicine as amine (Article 13(3) of defined in hydrochloride Directive No relevant national 2001/82/EC) legislation

Prolusyn 50 Syn Vet-Pharma VPA23174/001/ 50.0 Solution for - QH01CA01 POM: - Gonadorelin Generic - Intramuscular micrograms/ml Ireland Limited 001 microgram(s)/mil injection Prescription Only Acetate application use solution for lilitre Medicine as (Article 13(1) of injection for defined in Directive No cattle relevant national 2001/82/EC) legislation

Promec 18.7 ECO Animal VPA22693/016/ 18.7 Oral paste - QP54AA01 POM: - Ivermectin Informed - Oral use mg/g Oral Paste Health Europe 001 milligram(s)/gra Prescription Only consent for Horses Limited m Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Promox LA 150 Interchem VPA10555/010/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin (as Informed - Intramuscular mg/ml Ireland Ltd 001 milligram(s)/millil injection Prescription Only amoxicillin consent use Suspension for itre Medicine as trihydrate) application Injection defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Pronestesic 40 FATRO S.p.A. VPA10836/004/ 40, 0.036 Solution for - QN01BA52 VPO: Veterinary - Procaine Generic - Perineural use mg/ml + 0.036 001 milligram(s)/millil injection Practitioner Only hydrochloride application - Subcutaneous mg/ml solution itre as defined in - Epinephrine (Article 13(1) of use for injection for relevant national tartrate Directive No horses, cattle, legislation 2001/82/EC) pigs and sheep

Propalin Syrup Vetoquinol VPA10983/056/ 50 Syrup - QG04BX91 POM: - Full application - Oral use Ireland Limited 001 milligram(s)/millil Prescription Only Phenylpropanol (Article 12(3) of itre Medicine as amine Directive No defined in hydrochloride 2001/82/EC) relevant national legislation

Propen 300 Interchem VPA10555/009/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin Informed - Intramuscular mg/ml Ireland Ltd 001 milligram(s)/millil injection Prescription Only procaine consent use Suspension for itre Medicine as application Injection for defined in (Article 13c of Cattle, Sheep relevant national Directive No and Pigs legislation 2001/82/EC)

Propodine 10 Dechra VPA22622/034/ 10.0 Emulsion for - QN01AX10 VPO: Veterinary - Propofol Well-established - Intravenous mg/ml emulsion Regulatory B.V. 001 milligram(s)/millil injection/infusion Practitioner Only use application use for itre as defined in (Article 13a of injection/infusion relevant national Directive No for dogs and cat legislation 2001/82/EC)

PropoFlo Plus 10 Zoetis Belgium VPA10387/056/ 10 Emulsion for - QN01AX10 VPO: Veterinary - Propofol Full application - Intravenous mg/ml, Emulsion S.A. 001 milligram(s)/millil injection Practitioner Only (Article 12(3) of use for injection for itre as defined in Directive No dogs and cats relevant national 2001/82/EC) legislation

Propomitor 10 Orion VPA10664/008/ 10 Emulsion for - QN01AX10 VPO: Veterinary - Propofol Well-established - Intravenous mg/ml emulsion Corporation 001 milligram(s)/millil injection/infusion Practitioner Only use application use for itre as defined in (Article 13a of injection/infusion relevant national Directive No for dogs and cat legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 156 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Proposure 10 Axience VPA22873/001/ 10 Emulsion for - QN01AX10 VPO: Veterinary - Propofol Well-established - Intravenous mg/ml emulsion 001 milligram(s)/millil injection Practitioner Only use application use for injection for itre as defined in (Article 13a of dogs and cats relevant national Directive No legislation 2001/82/EC)

Prosolvin 7.5 Virbac S.A. VPA10988/078/ 7.5 Solution for - QG02AD91 POM: - Luprostiol Full application - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use for Injection itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Protect Oral Provita Eurotech VPA10865/001/ 0.373, 0.373, Oral suspension - QA07 LM: Licensed - Lactobacillus Full application - Oral use Suspension for Limited 001 0.373 percent Merchant as acidophilus LA (Article 12(3) of New Born weight/weight defined in 101 Directive No Calves relevant national - Lactobacillus 2001/82/EC) legislation acidophilus LA 107 - Enterococcus faecium SF 101 PROWORMER Ceva Santé VPA10815/019/ 525,175,175 Tablet - QP52AA51 CAM: - Febantel Hybrid - Oral use Flavoured tablets Animale 002 mg/tablet Companion - Pyrantel application for large dogs Animal Medicine - Praziquantel (Article 13(3) of as defined in Directive No relevant national 2001/82/EC) legislation

PROWORMER Ceva Santé VPA10815/019/ 150,50,50 Tablet - QP52AA51 CAM: - Febantel Hybrid - Oral use Flavoured tablets Animale 001 mg/tablet Companion - Pyrantel application for medium and Animal Medicine - Praziquantel (Article 13(3) of small dogs as defined in Directive No relevant national 2001/82/EC) legislation

PULMODOX 5 Virbac S.A. VPA10988/062/ 5 percent Premix for - QJ01AA02 POM: - Doxycyline - Oral use % PREMIX 001 weight/weight medicated Prescription Only feeding stuff Medicine as defined in relevant national legislation

Pulmotil G100 Elanco GmbH VPA22020/012/ 100 Premix for - QJ01FA91 POM: - Tilmicosin - Oral use Premix for 001 gram(s)/kilogra medicated Prescription Only phosphate medicated m(s) feeding stuff Medicine as feedingstuff defined in relevant national legislation

Pulmotil G200 Elanco GmbH VPA22020/012/ 200 Premix for - QJ01FA91 POM: - Tilmicosin - Oral use Premix for 002 gram(s)/kilogra medicated Prescription Only phosphate medicated m(s) feeding stuff Medicine as feedingstuff defined in relevant national legislation

Pulmovet 250 Dopharma VPA10791/010/ 250 Solution for use - QJ01FA91 POM: - Tilmicosin Generic - In drinking mg/ml solution Research B.V. 001 milligram(s)/millil in drinking water, Prescription Only application water/milk use for use in itre Milk or milk Medicine as (Article 13(1) of - Oral use drinking water or replacer defined in Directive No milk replacer for relevant national 2001/82/EC) cattle, pigs, legislation chickens and turkeys Qivitan 25 mg/ml LIVISTO Int'l, VPA10425/003/ 25 Suspension for - QJ01DE90 POM: - Cefquinome Generic - Intramuscular suspension for S.L. 001 milligram(s)/millil injection Prescription Only sulphate application use injection for itre Medicine as (Article 13(1) of cattle and pigs defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 157 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Qivitan LC 75 LIVISTO Int'l, VPA10425/006/ 75 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Hybrid - Intramammary mg S.L. 001 ointment Prescription Only sulphate application use intramammary Medicine as (Article 13(3) of ointment for defined in Directive No lactating cows relevant national 2001/82/EC) legislation

Qualimec 10 ECO Animal VPA22693/002/ 10 Solution for - QP54AA01 POM: - Ivermectin Well-established - Subcutaneous mg/ml Solution Health Europe 001 milligram(s)/millil injection Prescription Only use application use for Injection. Limited itre Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Qualimec Cattle ECO Animal VPA22693/004/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin - Topical use Pour-on Health Europe 001 milligram(s)/millil Prescription Only Limited itre Medicine as defined in relevant national legislation

Quanifen (50 mg Chanelle VPA10987/063/ 50, 500 Tablet - QP52AA51 CAM: - Praziquantel - Oral use Praziquantel / Pharmaceuticals 001 mg/tablet Companion - Fenbendazole 500 mg Manufacturing Animal Medicine Fenbendazole) Limited as defined in Tablets for Cats relevant national and Dogs legislation

Quenazole (50 Chanelle VPA10987/062/ 50/500 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use mg praziquantel / Pharmaceuticals 001 Companion - Fenbendazole application 500 mg Manufacturing Animal Medicine (Article 13(3) of Fenbendazole) Limited as defined in Directive No Tablets for Cats relevant national 2001/82/EC) and Dogs legislation

Quinoflox 100 GLOBAL VET VPA10477/001/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml solution HEALTH SL 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Rabisin Boehringer VPA10454/074/ . Suspension for - QI07AA02 POM: - Rabies virus Full application - Intramuscular Ingelheim 001 injection Prescription Only glycoprotein (Article 12(3) of use Vetmedica Medicine as Directive No - Subcutaneous GmbH defined in 2001/82/EC) use relevant national legislation

Rafazole Oral Chanelle VPA10987/012/ 30, 30 Oral suspension - QP52AE51 POM: - Rafoxanide - Oral use Suspension Pharmaceuticals 001 milligram(s)/millil Prescription Only - Levamisole Manufacturing itre Medicine as hydrochloride Limited defined in relevant national legislation

Ranide 30 mg/ml Univet Limited VPA10990/027/ 30 Oral suspension - QP52AG05 POM: - Rafoxanide - Oral use Oral Drench 001 milligram(s)/millil Prescription Only itre Medicine as defined in relevant national legislation

Rapidexon 2 Eurovet Animal VPA10989/056/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular mg/ml solution Health B.V. 001 milligram(s)/millil injection Prescription Only Dexamethasone application use for injection itre Medicine as (Article 13(1) of - Intrabursal use defined in Directive No - Intramuscular relevant national 2001/82/EC) use legislation - Intravenous use

Veterinary Medicines Authorised/Transfer Pending Products Page 158 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Receptal 0.004 Intervet Ireland VPA10996/123/ 0.004 Solution for - QH01CA90 POM: - Buserelin Full application - Intramuscular mg/ml Solution Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use for injection itre Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national - Subcutaneous legislation use

Recicort 1.77 Le Vet Beheer VPA10475/025/ 1.77, 17.7 Ear drops, - QD07XB02 POM: - Triamcinolone Generic - Auricular use mg/ml + 17.7 B.V. 001 milligram(s)/millil solution Prescription Only acetonide application mg/ml ear drops, itre Medicine as - Salicylic acid (Article 13(1) of solution for dogs defined in Directive No and cats relevant national 2001/82/EC) legislation

Regumate Intervet Ireland VPA10996/124/ 2.2 Oral solution - QG03DX90 POM: - Altrenogest Full application - Oral use Equine 2.2 Limited 001 milligram(s)/millil Prescription Only (Article 12(3) of mg/ml oral itre Medicine as Directive No solution for defined in 2001/82/EC) horses relevant national legislation

Release 300 WDT - VPA10660/001/ 300 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital Hybrid - Intracardiac mg/ml, solution Wirtschaftsgeno 001 milligram(s)/millil injection Practitioner Only sodium application use for injection ssenschaft itre as defined in (Article 13(3) of - Intraperitoneal deutscher relevant national Directive No use Tierarzte eG legislation 2001/82/EC) - Intravenous use - ZZZ Intrapulmonary use Repidose Ready Intervet Ireland VPA10996/254/ 1250 mg/tablet Pulsatile-release - QP52AC02 POM: - Oxfendazole Full application - Oral use Pulse Limited 001 intraruminal Prescription Only (Article 12(3) of device Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Repose 500 Le Vet Beheer VPA10475/030/ 500 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital Hybrid - Intracardiac mg/ml solution B.V. 001 milligram(s)/millil injection Practitioner Only sodium application use for injection itre as defined in (Article 13(3) of - Intraperitoneal relevant national Directive No use legislation 2001/82/EC) - Intravenous use

Reprocine 0.07 Vetoquinol SA VPA10521/002/ 0.07 Solution for - QH01BB03 POM: - Carbetocin Well-established - Intramuscular mg/ml solution 001 milligram(s)/millil injection Prescription Only use application use for injection for itre Medicine as (Article 13a of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) legislation

ReproCyc PRRS Boehringer VPA10454/012/ . Lyophilisate and - QI09AD03 POM: - Live attenuated Full application - Intramuscular EU lyophilisate Ingelheim 001 solvent for Prescription Only prrs 94881 virus (Article 12(3) of use and solvent for Vetmedica suspension for Medicine as Directive No suspension for GmbH injection defined in 2001/82/EC) injection for pigs relevant national legislation

Resflam 300/20 Norbrook VPA22664/085/ 300, 20 Solution for - QJ01AA56 POM: - Oxytetracycline Informed - Intramuscular mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only dihydrate consent use for Injection for (Ireland) Limited itre Medicine as - Flunixin application Cattle defined in meglumine (Article 13c of relevant national Directive No legislation 2001/82/EC)

RESFLOR Intervet Ireland VPA10996/255/ 300/16.5 Solution for - QJ01BA99 POM: - Flunixin Fixed - Subcutaneous 300/16.5 mg/mL Limited 001 milligram(s)/millil injection Prescription Only - Florfenicol combination use Solution for itre Medicine as application Injection for defined in (Article 13b of Cattle relevant national Directive No legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 159 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration RESPICHLOR Interchem VPA10555/004/ 150 Oral powder - QJ01AA03 POM: - - Oral use 15% w/w Oral Ireland Ltd 001 milligram(s)/gra Prescription Only Chlortetracycline Powder m Medicine as hydrochloride defined in relevant national legislation

Revertor 5 mg/ml CP-Pharma VPA10810/004/ 5 Solution for - QV03AB90 POM: - Atipamezole Generic - Intramuscular Solution for Handelsgesellsc 001 milligram(s)/millil injection Prescription Only hydrochloride application use Injection for haft mbH itre Medicine as (Article 13(1) of Dogs and Cats defined in Directive No relevant national 2001/82/EC) legislation

Revozyn RTU Eurovet Animal VPA10989/071/ 400 Suspension for - QJ01CE90 POM: - Penethamate Hybrid - Intramuscular 400 mg/ml Health B.V. 001 milligram(s)/millil injection Prescription Only hydriodide application use suspension for itre Medicine as (Article 13(3) of injection for defined in Directive No cattle. relevant national 2001/82/EC) legislation

Rhemox 500 Industrial VPA10509/006/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - In drinking mg/g powder for Veterinaria, S.A. 001 milligram(s)/gra in drinking water Prescription Only trihydrate application water use use in drinking m Medicine as (Article 13(1) of water for pigs, defined in Directive No chicken broilers, relevant national 2001/82/EC) duck broilers and legislation turkeys for meat production

Rhinovac IBR Animal Health VPA22715/004/ . Lyophilisate and - QI02AD01 POM (E): - Bovine Full application - Intramuscular Marker live Distributors 001 solvent for Prescription Only herpesvirus 1, (Article 12(3) of use Lyophilisate and Limited suspension for Exempt as strain bio-27 live Directive No - Nasal use solvent for injection defined in 2001/82/EC) suspension for relevant national injection or nasal legislation spray for cattle.

Ridacox 50 J. & M. VPA10954/012/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml oral Veterinary 001 milligram(s)/millil Prescription Only application suspension for Services Ltd itre Medicine as (Article 10(1) of cattle and sheep defined in Directive No relevant national 2001/83/EC) legislation

Ridafluke 30 Chanelle VPA10987/013/ 30 Oral suspension - QP52AG05 POM: - Rafoxanide - Oral use mg/ml Oral Pharmaceuticals 001 milligram(s)/millil Prescription Only Suspension Manufacturing itre Medicine as Limited defined in relevant national legislation

Ridamec 1 Chanelle VPA10987/112/ 1 Oral solution - QP54AB02 POM: - Moxidectin Generic - Oral use mg/ml oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application solution for Manufacturing itre Medicine as (Article 13(1) of sheep Limited defined in Directive No relevant national 2001/82/EC) legislation

Ridaworm 20 mg Chanelle VPA10987/164/ 20 mg/pipette Spot-on solution - QP52AA01 CAM: - Praziquantel Hybrid - Spot-on use Spot-on Solution Pharmaceuticals 001 Companion application for small cats Manufacturing Animal Medicine (Article 13(3) of Limited as defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 160 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Ridaworm 40 mg Chanelle VPA10987/164/ 40 mg/pipette Spot-on solution - QP52AA01 CAM: - Praziquantel Hybrid - Spot-on use Spot-on Solution Pharmaceuticals 002 Companion application for medium cats Manufacturing Animal Medicine (Article 13(3) of Limited as defined in Directive No relevant national 2001/82/EC) legislation

Ridaworm 60 mg Chanelle VPA10987/164/ 60 mg/pipette Spot-on solution - QP52AA01 CAM: - Praziquantel Hybrid - Spot-on use Spot-on Solution Pharmaceuticals 003 Companion application for large cats Manufacturing Animal Medicine (Article 13(3) of Limited as defined in Directive No relevant national 2001/82/EC) legislation

Rifen 100 mg/ml Richter Pharma VPA10801/003/ 100 Solution for - QM01AE03 POM: - Ketoprofen Generic - Intramuscular solution for AG 001 milligram(s)/millil injection Prescription Only application use injection for itre Medicine as (Article 13(1) of - Intravenous horses, cattle defined in Directive No use and swine relevant national 2001/82/EC) legislation

Rilexine 300 mg Virbac S.A. VPA10988/018/ 300 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin ZZZ Informed - Oral use Tablets for dogs 002 Prescription Only monohydrate consent Medicine as (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

Rilexine 600 mg Virbac S.A. VPA10988/018/ 600 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin ZZZ Informed - Oral use Tablets for dogs 003 Prescription Only monohydrate consent Medicine as (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

Rilexine 75 mg Virbac S.A. VPA10988/018/ 75 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin ZZZ Informed - Oral use Tablets for dogs 001 Prescription Only monohydrate consent and cats Medicine as (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

RIMADYL Cattle Zoetis Belgium VPA10387/058/ 50 Solution for - QM01AE91 POM: - Carprofen Full application - Intravenous 50 mg/ml S.A. 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use Solution for itre Medicine as Directive No - Subcutaneous Injection defined in 2001/82/EC) use relevant national legislation

Rimadyl Zoetis Belgium VPA10387/059/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Palatable S.A. 003 Prescription Only application Tablets 100 mg Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Rimadyl Zoetis Belgium VPA10387/059/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Palatable S.A. 001 Prescription Only application Tablets 20 mg Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Rimadyl Zoetis Belgium VPA10387/059/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Palatable S.A. 002 Prescription Only application Tablets 50 mg Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 161 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Rimifin 100 mg Chanelle VPA10987/066/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for dogs Pharmaceuticals 003 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Rimifin 20 mg Chanelle VPA10987/066/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for dogs Pharmaceuticals 001 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Rimifin 50 mg Chanelle VPA10987/066/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for dogs Pharmaceuticals 002 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Rino LHV Bonapp HOVR10466/00 Oral solution LM: Licensed - Thuya - Oral use 1/001 Merchant as - Calendula defined in officinalis relevant national - Calcarea legislation carbonica - Bellis perennis - Silicea - Solidago virgaurea Rispoval 2 / Zoetis Belgium VPA10387/100/ . Lyophilisate and - QI02AD07 POM (E): - Bovine Para Full application - Intramuscular BRSV + Pi3 S.A. 001 solvent for Prescription Only Influenza 3 (Article 12(3) of use Lyophilisate and suspension for Exempt as Virus, live Directive No solvent for injection defined in - Bovine 2001/82/EC) suspension for relevant national respiratory injection for legislation syncytial virus, cattle live Rispoval 3 BRSV Zoetis Belgium VPA10387/060/ 10^5.0 - 10^8.6 Lyophilisate and - QI02AH POM (E): - Parainfluenza 3 Full application - Intramuscular Pi3 BVD S.A. 001 cell culture suspension for Prescription Only virus, modified (Article 12(3) of use Lyophilisate and infective dose suspension for Exempt as live, strain rlb103 Directive No suspension for 50/dose injection defined in - Bovine 2001/82/EC) suspension for relevant national respiratory injection for legislation syncytial virus, cattle modified live, strain 375 - Inactivated bovine viral diarrhoea virus 1, strain 5960 (cytopathic) - Inactivated bovine viral diarrhoea virus type 1 strain 6309 (non cytopathic)

Rispoval IBR- Zoetis Belgium VPA10387/061/ . Suspension for - QI02AA03 POM (E): - Bovine herpes Full application - Subcutaneous Marker S.A. 001 injection Prescription Only virus type 1 (Article 12(3) of use Inactivated Exempt as (BHV-1), strain Directive No defined in difivac 2001/82/EC) relevant national legislation

Rispoval IBR- Zoetis Belgium VPA10387/062/ . Lyophilisate and - QI02AD01 POM (E): - Bovine herpes Full application - Intramuscular Marker Live S.A. 001 solvent for Prescription Only virus type 1 (Article 12(3) of use suspension for Exempt as (BHV-1), strain Directive No - ZZZ Intranasal injection defined in difivac (gE- 2001/82/EC) use relevant national negative), legislation modified live (attenuated) virus

Veterinary Medicines Authorised/Transfer Pending Products Page 162 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration RISPOVAL RS Zoetis Belgium VPA10387/063/ . Powder for - QI02AD04 POM (E): - Live attenuated Full application - Intramuscular S.A. 001 suspension for Prescription Only bovine (Article 12(3) of use injection Exempt as respiratory Directive No defined in syncytial virus; 2001/82/EC) relevant national strain rb94 legislation

Rispoval RS+PI3 Zoetis Belgium VPA10387/064/ 10^5.0-10^8.6 / pdr and diluent - QI02AD07 POM (E): - Bovine Full application - ZZZ Intranasal IntraNasal S.A. 001 10^5.0-10^7.2 for intra-nasal Prescription Only parainfluenza 3 (Article 12(3) of use cell culture soln Exempt as virus (pi3v), rlb Directive No infective dose 50 defined in 103, attenuated 2001/82/EC) relevant national - Bovine legislation respiratory syncytial virus (brsv), strain 375 attenuated Robonex 5 Norbrook VPA22664/104/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Hybrid - Topical use mg/ml Pour-On Laboratories 001 milligram(s)/millil Prescription Only application Solution for Beef (Ireland) Limited itre Medicine as (Article 13(3) of and Dairy Cattle defined in Directive No relevant national 2001/82/EC) legislation

Rofeniflex 100 Chanelle VPA10987/067/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use mg Tablets for Pharmaceuticals 003 Prescription Only application dogs Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Rofeniflex 20 mg Chanelle VPA10987/067/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for dogs Pharmaceuticals 001 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Rofeniflex 50 mg Chanelle VPA10987/067/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use Tablets for dogs Pharmaceuticals 002 Prescription Only application Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Rominervin 10 Le Vet Beheer VPA10475/040/ 10 Solution for - QN05CM93 VPO: Veterinary - Romifidine Generic - Intravenous mg/ml solution B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for itre as defined in (Article 13(1) of horses relevant national Directive No legislation 2001/82/EC)

Ronaxan 100 mg Boehringer VPA10454/075/ 100 mg/tablet Tablet - QJ01AA02 POM: - Doxycycline - Oral use tablet Ingelheim 002 Prescription Only Vetmedica Medicine as GmbH defined in relevant national legislation

Ronaxan 20 mg Boehringer VPA10454/075/ 20 mg/tablet Tablet - QJ01AA02 POM: - Doxycycline - Oral use tablet Ingelheim 001 Prescription Only Vetmedica Medicine as GmbH defined in relevant national legislation

ROXACIN 100 LABORATORIO VPA10665/002/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml solution S CALIER S.A. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Veterinary Medicines Authorised/Transfer Pending Products Page 163 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Rumenil 34 Chanelle VPA10987/113/ 34 Oral suspension - QP52AG05 POM: - Oxyclozanide Generic - Oral use mg/ml oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application suspension for Manufacturing itre Medicine as (Article 13(1) of cattle Limited defined in Directive No relevant national 2001/82/EC) legislation

Rycarfa 100 mg Krka, d.d., Novo VPA10774/027/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use tablets for dogs mesto 003 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Rycarfa 20 mg Krka, d.d., Novo VPA10774/027/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use tablets for dogs mesto 001 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Rycarfa 50 mg Krka, d.d., Novo VPA10774/027/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use tablets for dogs mesto 002 Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Rycarfa 50 Krka, d.d., Novo VPA10774/028/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous dogs and cats defined in Directive No use relevant national 2001/82/EC) legislation

Salmoporc Ceva Santé VPA10815/064/ . Lyophilisate and - QI09AE02 POM: - Salmonella Similar biological - Oral use lyophilisate and Animale 001 solvent for Prescription Only typhimurium application - Subcutaneous solvent for suspension for Medicine as mutant, strain (Article 13(4) of use suspension for injection defined in 421/125 Directive No injection for pigs relevant national 2001/82/EC) legislation

Salmoporc Ceva Santé VPA10815/064/ . Lyophilisate for - QI09AE02 POM: - Salmonella Similar biological - Oral use lyophilisate for Animale 002 oral suspension Prescription Only typhimurium application oral suspension Medicine as mutant, strain (Article 13(4) of for pigs defined in 421/125 Directive No relevant national 2001/82/EC) legislation

SALMOVAC 440 Ceva Santé VPA10815/063/ 1x10^8 - 8x10^8 Oral lyophilisate - QI01AE01 POM: - Salmonella Full application - Oral use Lyophilisate for Animale 001 Colony forming Prescription Only enteritidis, strain (Article 12(3) of use in drinking units Medicine as no. 441/014 Directive No water defined in 2001/82/EC) relevant national legislation

Santiola 50 Krka, d.d., Novo VPA10774/048/ 50 Solution for - QP52AG09 POM: - Closantel Generic - Subcutaneous mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only sodium dihydrate application use for injection for itre Medicine as (Article 13(1) of cattle and sheep defined in Directive No relevant national 2001/82/EC) legislation

Scabivax Intervet Ireland VPA10996/256/ . Suspension for - QI04AD01 POM: - Contagious Full application - Skin Contagious Limited 001 skin scarification Prescription Only pustular (Article 12(3) of scarification pustular Medicine as dermatitis Directive No dermatitis (Orf) defined in 2001/82/EC) vaccine relevant national Suspension for legislation skin scarification

Veterinary Medicines Authorised/Transfer Pending Products Page 164 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Scalibor Intervet Ireland VPA10996/173/ 0.76 gram(s) Collar - QP53AC11 POM: - Deltamethrin - Topical use Protectorband Limited 001 Prescription Only 0.76 g medicated Medicine as collar for small defined in and medium relevant national sized dogs legislation

Scalibor Intervet Ireland VPA10996/173/ 1.0 gram(s) Collar - QP53AC11 POM: - Deltamethrin - Topical use Protectorband Limited 002 Prescription Only 1.0 g medicated Medicine as collar for large defined in sized dogs relevant national legislation

Seclaris DC 250 Ceva Santé VPA10815/047/ 250 mg/syringe Intramammary - QJ51DB90 POM: - Cefalonium (as Hybrid - Intramammary mg Animale 001 suspension Prescription Only cefalonium application use Intramammary Medicine as dihydrate?) (Article 13(3) of Suspension for defined in Directive No dry cows relevant national 2001/82/EC) legislation

Sedalin Oral Gel Vetoquinol VPA10983/057/ 3.5 percent Oral gel - QN05AA04 POM: - Acepromazine Full application - Oral use 3.5 %w/v Ireland Limited 001 weight/volume Prescription Only maleate (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Sedanol 40 Richter Pharma VPA10801/015/ 40 Solution for - QN05AD90 POM: - Azaperone Generic - Intramuscular mg/ml solution AG 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of pigs defined in Directive No relevant national 2001/82/EC) legislation

Sedastart 1 Le Vet BV VPA10816/008/ 1 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Generic - Intramuscular mg/ml solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for itre as defined in (Article 13(1) of - Intravenous cats and dogs relevant national Directive No use legislation 2001/82/EC)

Sedastop 5 Le Vet BV VPA10816/009/ 5 Solution for - QV03AB90 POM: - Atipamezole Generic - Intramuscular mg/ml solution 001 milligram(s)/millil injection Prescription Only hydrochloride application use for injection for itre Medicine as (Article 13(1) of cats and dogs defined in Directive No relevant national 2001/82/EC) legislation

SEDATOR, 1.0 Eurovet Animal VPA10989/057/ 1.0 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Generic - Intramuscular mg/ml, solution Health B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for itre as defined in (Article 13(1) of - Intravenous cats and dogs relevant national Directive No use legislation 2001/82/EC) - Subcutaneous use

Sedaxylan, 20 Eurovet Animal VPA10989/050/ 20 Solution for - QN05CM92 VPO: Veterinary - Xylazine base Generic - Intramuscular mg/ml solution Health B.V. 001 milligram(s)/millil injection Practitioner Only application use for injection for itre as defined in (Article 13(1) of - Intravenous dogs, cats, relevant national Directive No use horses and cattl legislation 2001/82/EC) - Subcutaneous use

Sedecalm 1 Industrial VPA10509/007/ 1 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Generic - Intramuscular mg/ml solution Veterinaria, S.A. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for 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

Veterinary Medicines Authorised/Transfer Pending Products Page 165 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Sedectin 20 Interchemie VPA22812/002/ 20 Solution for - QN05CM92 VPO: Veterinary - Xylazine Generic - Intramuscular mg/ml solution Werken De 001 milligram(s)/millil injection Practitioner Only Hydrochloride for application use for injection for Adelaar Eesti AS itre as defined in Veterinary Use (Article 13(1) of - Intravenous cattle, horses, relevant national Directive No use dogs and cats legislation 2001/82/EC) - Subcutaneous use

Sedivet 10 Boehringer VPA10454/013/ 10 Solution for - QN05CM93 VPO: Veterinary - Romifidine Full application - Intravenous mg/ml Solution Ingelheim 001 milligram(s)/millil injection Practitioner Only (Article 12(3) of use for Injection for Vetmedica itre as defined in Directive No horses GmbH relevant national 2001/82/EC) legislation

Selames 120 mg Krka, d.d., Novo VPA10774/056/ 120 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use spot-on solution mesto 003 Prescription Only application for dogs 10.1– Medicine as (Article 13(1) of 20.0 kg defined in Directive No relevant national 2001/82/EC) legislation

Selames 15 mg Krka, d.d., Novo VPA10774/055/ 15 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use spot-on solution mesto 001 Prescription Only application for cats and dogs Medicine as (Article 13(1) of = 2.5 kg defined in Directive No relevant national 2001/82/EC) legislation

Selames 240 mg Krka, d.d., Novo VPA10774/056/ 240 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use spot-on solution mesto 004 Prescription Only application for dogs 20.1– Medicine as (Article 13(1) of 40.0 kg defined in Directive No relevant national 2001/82/EC) legislation

Selames 30 mg Krka, d.d., Novo VPA10774/056/ 30 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use spot-on solution mesto 001 Prescription Only application for dogs 2.6–5.0 Medicine as (Article 13(1) of kg defined in Directive No relevant national 2001/82/EC) legislation

Selames 360 mg Krka, d.d., Novo VPA10774/056/ 360 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use spot-on solution mesto 005 Prescription Only application for dogs 40.1– Medicine as (Article 13(1) of 60.0 kg defined in Directive No relevant national 2001/82/EC) legislation

Selames 45 mg Krka, d.d., Novo VPA10774/055/ 45 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use spot-on solution mesto 002 Prescription Only application for cats 2.6–7.5 Medicine as (Article 13(1) of kg defined in Directive No relevant national 2001/82/EC) legislation

Selames 60 mg Krka, d.d., Novo VPA10774/055/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use spot-on solution mesto 003 Prescription Only application for cats 7.6–10.0 Medicine as (Article 13(1) of kg defined in Directive No relevant national 2001/82/EC) legislation

Selames 60 mg Krka, d.d., Novo VPA10774/056/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use spot-on solution mesto 002 Prescription Only application for dogs 5.1– Medicine as (Article 13(1) of 10.0 kg defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 166 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration SELAPRO 120 Norbrook VPA22664/144/ 120 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use mg spot-on Laboratories 006 Prescription Only application solution for (Ireland) Limited Medicine as (Article 13(3) of medium dogs defined in Directive No (10.1–20.0 kg) relevant national 2001/82/EC) legislation

SELAPRO 15 Norbrook VPA22664/144/ 15 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use mg spot-on Laboratories 001 Prescription Only application solution for dogs (Ireland) Limited Medicine as (Article 13(3) of and cats (< 2.5 defined in Directive No kg) relevant national 2001/82/EC) legislation

SELAPRO 240 Norbrook VPA22664/144/ 240 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use mg spot-on Laboratories 007 Prescription Only application solution for large (Ireland) Limited Medicine as (Article 13(3) of dogs (20.1–40.0 defined in Directive No kg) relevant national 2001/82/EC) legislation

SELAPRO 30 Norbrook VPA22664/144/ 30 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use mg spot-on Laboratories 004 Prescription Only application solution for very (Ireland) Limited Medicine as (Article 13(3) of small dogs (2.6– defined in Directive No 5.0 kg) relevant national 2001/82/EC) legislation

SELAPRO 360 Norbrook VPA22664/144/ 360 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use mg spot-on Laboratories 008 Prescription Only application solution for very (Ireland) Limited Medicine as (Article 13(3) of large dogs defined in Directive No (40.1–60.0 kg) relevant national 2001/82/EC) legislation

SELAPRO 45 Norbrook VPA22664/144/ 45 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use mg spot-on Laboratories 002 Prescription Only application solution for cats (Ireland) Limited Medicine as (Article 13(3) of (2.6–7.5 kg) defined in Directive No relevant national 2001/82/EC) legislation

SELAPRO 60 Norbrook VPA22664/144/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use mg spot-on Laboratories 003 Prescription Only application solution for large (Ireland) Limited Medicine as (Article 13(3) of cats (7.6–10.0 defined in Directive No kg) relevant national 2001/82/EC) legislation

SELAPRO 60 Norbrook VPA22664/144/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use mg spot-on Laboratories 005 Prescription Only application solution for small (Ireland) Limited Medicine as (Article 13(3) of dogs (5.1–10.0 defined in Directive No kg) relevant national 2001/82/EC) legislation

SELECTAN 300 Laboratorios VPA10846/008/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular mg/ml solution Hipra S.A. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of cattle and swine defined in Directive No relevant national 2001/82/EC) legislation

SELECTAN Laboratorios VPA10846/012/ 23 Solution for use - QJ01BA90 POM: - Florfenicol Generic - Oral use ORAL 23 mg/ml Hipra S.A. 001 milligram(s)/millil in drinking water Prescription Only application solution for use itre Medicine as (Article 13(1) of in drinking water defined in Directive No for pigs relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 167 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Selehold 120 mg Krka, d.d., Novo VPA10774/054/ 120 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use spot-on solution mesto 003 Prescription Only application for dogs 10.1– Medicine as (Article 13(3) of 20.0 kg defined in Directive No relevant national 2001/82/EC) legislation

Selehold 15 mg Krka, d.d., Novo VPA10774/053/ 15 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use spot-on solution mesto 001 Prescription Only application for cats and dogs Medicine as (Article 13(3) of = 2.5 kg defined in Directive No relevant national 2001/82/EC) legislation

Selehold 240 mg Krka, d.d., Novo VPA10774/054/ 240 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use spot-on solution mesto 004 Prescription Only application for dogs 20.1– Medicine as (Article 13(3) of 40.0 kg defined in Directive No relevant national 2001/82/EC) legislation

Selehold 30 mg Krka, d.d., Novo VPA10774/054/ 30 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use spot-on solution mesto 001 Prescription Only application for dogs 2.6–5.0 Medicine as (Article 13(3) of kg defined in Directive No relevant national 2001/82/EC) legislation

Selehold 360 mg Krka, d.d., Novo VPA10774/054/ 360 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use spot-on solution mesto 005 Prescription Only application for dogs 40.1– Medicine as (Article 13(3) of 60.0 kg defined in Directive No relevant national 2001/82/EC) legislation

Selehold 45 mg Krka, d.d., Novo VPA10774/053/ 45 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use spot-on solution mesto 002 Prescription Only application for cats 2.6–7.5 Medicine as (Article 13(3) of kg defined in Directive No relevant national 2001/82/EC) legislation

Selehold 60 mg Krka, d.d., Novo VPA10774/053/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use spot-on solution mesto 003 Prescription Only application for cats 7.6–10.0 Medicine as (Article 13(3) of kg defined in Directive No relevant national 2001/82/EC) legislation

Selehold 60 mg Krka, d.d., Novo VPA10774/054/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use spot-on solution mesto 002 Prescription Only application for dogs 5.1– Medicine as (Article 13(3) of 10.0 kg defined in Directive No relevant national 2001/82/EC) legislation

Selgian 20 kg, Ceva Santé VPA10815/062/ 8.37 mg/tablet Film-coated - QN06A POM: - Selegiline - Oral use Film coated Animale 002 tablet Prescription Only hydrochloride tablets Medicine as defined in relevant national legislation

Selgian 40 kg, Ceva Santé VPA10815/062/ 16.74 mg/tablet Film-coated - QN06A POM: - Selegiline - Oral use Film coated Animale 003 tablet Prescription Only hydrochloride tablets Medicine as defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 168 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Selgian 8 kg, Ceva Santé VPA10815/062/ 3.35 mg/tablet Film-coated - QN06A POM: - Selegiline - Oral use Film coated Animale 001 tablet Prescription Only hydrochloride tablets Medicine as defined in relevant national legislation

SEMELCEF FATRO S.p.A. VPA10836/006/ 1000 mg/tablet Tablet - QJ01DB05 POM: - Cefadroxil Generic - Oral use 1000 mg tablets 002 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

SEMELCEF 200 FATRO S.p.A. VPA10836/006/ 200 mg/tablet Tablet - QJ01DB05 POM: - Cefadroxil Generic - Oral use mg tablets for 001 Prescription Only application dogs and cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Sensiblex 40 Veyx-Pharma VPA10539/005/ 40.0 Solution for - QG02CX90 POM: - Denaverine Generic - Intramuscular mg/ml solution GmbH 001 milligram(s)/millil injection Prescription Only hydrochloride application use for injection for itre Medicine as (Article 13(1) of cattle defined in Directive No relevant national 2001/82/EC) legislation

Septotryl II Vetoquinol VPA10983/026/ 40, 200 Solution for - QJ01EW10 POM: - Trimethoprim Informed - Intramuscular Solution for Ireland Limited 001 milligram(s)/millil injection Prescription Only - Sulfadiazine consent use Injection itre Medicine as application - Intravenous defined in (Article 13c of use relevant national Directive No - Subcutaneous legislation 2001/82/EC) use

Seresto 1.25 g + Elanco GmbH VPA22020/051/ 1.25 + 0.56 Collar - QP53AC55 POM: - Imidacloprid Fixed - Cutaneous use 0.56 g, collar for 001 gram(s)/collar Prescription Only - Flumethrin combination cats Medicine as application defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Seresto 1.25 g + Elanco GmbH VPA22020/051/ 1.25 + 0.56 Collar - QP53AC55 POM: - Imidacloprid Fixed - Cutaneous use 0.56 g, collar for 002 gram(s)/collar Prescription Only - Flumethrin combination dogs <= 8 kg Medicine as application defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Seresto 4.50 g + Elanco GmbH VPA22020/051/ 4.50 + 2.03 Collar - QP53AC55 POM: - Imidacloprid Fixed - Cutaneous use 2.03 g, collar for 003 gram(s)/collar Prescription Only - Flumethrin combination dogs > 8 kg Medicine as application defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Sergeants Pet The Bob Martin VPA10881/016/ 0.1, 0.2, 0.5 Cutaneous - QP53AC CAM: - Tetramethrin Well-established - Topical use Patrol Aerosol Company 001 percent spray, solution Companion (90%) use application weight/weight Animal Medicine - Phenothrin (Article 13a of as defined in - Piperonyl Directive No relevant national Butoxide (90%) 2001/82/EC) legislation

Sincrovet 75 Industria Italiana VPA10380/001/ 75 Solution for - QG02AD90 POM: - (+)- Informed - Intramuscular micrograms/ml Integratori Trei 001 microgram(s)/mil injection Prescription Only closprostenol consent use solution for Spa lilitre Medicine as sodium salt application injection for defined in (Article 13c of cattle, horses relevant national Directive No and pigs legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 169 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration SLICE 2 mg/g Intervet Ireland VPA10996/257/ 2 Premix for - QP54AA06 POM: - Emamectin Full application - Oral use premix for Limited 001 milligram(s)/gra medicated Prescription Only benzoate (Article 12(3) of medicated m feeding stuff Medicine as Directive No feeding stuff defined in 2001/82/EC) relevant national legislation

Sodium Chloride B. Braun VPA10465/004/ 0.9 grams/100 Solution for - QB05BB01 POM: - Sodium Well-established - Intravenous 0.9 g/100 ml B. Melsungen AG 001 millilitres infusion Prescription Only chloride use application use Braun Vet Care Medicine as (Article 13a of solution for defined in Directive No infusion for relevant national 2001/82/EC) cattle, horse, legislation sheep, goat, pig, dog and cat

Sodium Salicyl Dopharma VPA10791/003/ 800 Powder for oral - QN02BA04 POM: - Sodium Generic - Oral use 800 mg/g, Research B.V. 001 milligram(s)/gra solution Prescription Only salicylate application powder for oral m Medicine as (Article 13(1) of solution for cattle defined in Directive No (calves) and pigs relevant national 2001/82/EC) legislation

Solacyl 1000 Eurovet Animal VPA10989/054/ 1000 Powder for oral - QN02BA04 POM: - Sodium Generic - Oral use mg/g, powder for Health B.V. 001 milligram(s)/gra solution Prescription Only salicylate application oral solution for m Medicine as (Article 13(1) of cattle and pigs defined in Directive No relevant national 2001/82/EC) legislation

Solamocta 697 Eurovet Animal VPA10989/064/ 697 Powder for oral - QJ01CA04 POM: - Amoxicillin Hybrid - Oral use mg/g powder for Health B.V. 001 milligram(s)/gra solution Prescription Only application use in drinking m Medicine as (Article 13(3) of water for defined in Directive No chickens, ducks relevant national 2001/82/EC) and turkeys legislation

Solantel 200 Norbrook VPA22664/150/ 200 Pour-on solution - QP52AG09 POM: - Closantel Full application - Pour-on use mg/ml Pour-On Laboratories 001 milligram(s)/millil Prescription Only sodium dihydrate (Article 12(3) of Solution for (Ireland) Limited itre Medicine as Directive No Cattle defined in 2001/82/EC) relevant national legislation

Solantel 50 Norbrook VPA22664/128/ 50 Oral suspension - QP52AG09 POM: - Closantel Generic - Oral use mg/ml Oral Laboratories 001 milligram(s)/millil Prescription Only sodium dihydrate application Suspension for (Ireland) Limited itre Medicine as (Article 13(1) of Sheep defined in Directive No relevant national 2001/82/EC) legislation

Soloxine 0.1 mg Virbac S.A. VPA10988/069/ 0.1 mg/tablet Tablet - QH03AA01 POM: - Levothyroxine - Oral use Tablet 001 Prescription Only sodium Medicine as defined in relevant national legislation

Soloxine 0.2 mg Virbac S.A. VPA10988/069/ 0.2 mg/tablet Tablet - QH03AA01 POM: - Levothyroxine - Oral use Tablet 002 Prescription Only sodium Medicine as defined in relevant national legislation

Soloxine 0.3 mg Virbac S.A. VPA10988/069/ 0.3 mg/tablet Tablet - QH03AA01 POM: - Levothyroxine - Oral use Tablet 003 Prescription Only sodium Medicine as defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 170 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Soloxine 0.5 mg Virbac S.A. VPA10988/069/ 0.5 mg/tablet Tablet - QH03AA01 POM: - Levothyroxine - Oral use Tablet 004 Prescription Only sodium Medicine as defined in relevant national legislation

Soloxine 0.8 mg Virbac S.A. VPA10988/069/ 0.8 mg/tablet Tablet - QH03AA01 POM: - Levothyroxine - Oral use Tablet 005 Prescription Only sodium Medicine as defined in relevant national legislation

Soluchlor 150 Interchem VPA10555/011/ 150 Oral powder - QJ01AA03 POM: - Informed - Oral use mg/g Oral Ireland Ltd 001 milligram(s)/gra Prescription Only Chlortetracycline consent Powder for m Medicine as hydrochloride application Calves defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Soludox 500 Eurovet Animal VPA10989/072/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Hybrid - In drinking mg/g powder for Health B.V. 001 milligram(s)/gra in drinking water Prescription Only hyclate application water use use in drinking m Medicine as (Article 13(3) of water for pigs defined in Directive No and chickens relevant national 2001/82/EC) legislation

Solupam 5 Le Vet Beheer VPA10475/142/ 5 Solution for - QN05BA01 VPO: Veterinary - Diazepam Generic - Intravenous mg/ml solution B.V. 001 milligram(s)/millil injection Practitioner Only application use for injection for itre as defined in (Article 13(1) of dogs and cats relevant national Directive No legislation 2001/82/EC)

Solvasol Norbrook VPA22664/060/ 180 Suspension for - QJ01DB01 POM: - Cefalexin - Intramuscular Injection Laboratories 001 milligram(s)/millil injection Prescription Only Sodium use (Ireland) Limited itre Medicine as - Subcutaneous defined in use relevant national legislation

SOMNIPRON 10 Vetpharma VPA10516/014/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomidine Generic - Intramuscular mg/ml Solution Animal Health, 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for S.L. itre as defined in (Article 13(1) of - Intravenous horses and cattl relevant national Directive No use legislation 2001/82/EC)

Somulose Dechra VPA22622/018/ 400/25 Solution for - QN05CB02 VPO: Veterinary - Secobarbital Well-established - Intravenous Solution for Regulatory B.V. 001 milligram(s)/millil injection Practitioner Only sodium use application use Injection itre as defined in - Cinchocaine (Article 13a of relevant national Hydrochloride Directive No legislation 2001/82/EC)

Spasmalgan Veyx-Pharma VPA10539/007/ 500.0,4.0 Solution for - QA03DB04 POM: - Metamizole Generic - Intramuscular compositum 500 GmbH 001 milligram(s)/millil injection Prescription Only sodium application use mg/ml + 4 mg/ml itre Medicine as monohydrate (Article 13(1) of - Intravenous Solution for defined in - Hyoscine Directive No use injection for relevant national butylbromide 2001/82/EC) horses, cattle, legislation pigs and dogs Spasmipur 20 Richter Pharma VPA10801/013/ 20 Solution for - QA03BB01 POM: - Hyoscine Generic - Intramuscular mg/ml solution AG 001 milligram(s)/millil injection Prescription Only butylbromide application use for injection itre Medicine as (Article 13(1) of - Intravenous defined in Directive No use relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 171 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Spasmium Richter Pharma VPA10801/008/ 500.0/4.0 Solution for - QA03DB04 POM: - Metamizole Generic - Intramuscular comp. 500 mg/ml AG 001 milligram(s)/millil injection Prescription Only sodium application use + 4 mg/ml itre Medicine as monohydrate (Article 13(1) of - Intravenous solution for defined in - Hyoscine Directive No use injection relevant national butylbromide 2001/82/EC) legislation

Spectam Ceva Santé VPA10815/060/ 10 percent Solution for - QJ01XX04 POM: - Spectinomycin Full application - Intramuscular Injectable 10 % Animale 001 weight/volume injection Prescription Only dihydrochloride (Article 12(3) of use w/v Medicine as pentahydrate Directive No defined in 2001/82/EC) relevant national legislation

Spectam Scour Ceva Santé VPA10815/059/ 50 Oral solution - QJ01XX04 POM: - Spectinomycin Full application - Oral use Halt Oral Animale 001 milligram(s)/millil Prescription Only dihydrochloride (Article 12(3) of Solution 50 itre Medicine as pentahydrate Directive No mg/ml defined in 2001/82/EC) relevant national legislation

SPECTRON 100 Laboratorios VPA10846/011/ 100 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml solution Hipra S.A. 001 milligram(s)/millil Prescription Only application for use in itre Medicine as (Article 13(1) of drinking water for defined in Directive No chickens and relevant national 2001/82/EC) turkeys legislation

Spirovac Zoetis Belgium VPA10387/065/ . Suspension for - QI02AB03 LM: Licensed - Inactivated Full application - Subcutaneous S.A. 001 injection Merchant as leptospira (Article 12(3) of use defined in borgpetersenii Directive No relevant national serovar hardjo 2001/82/EC) legislation type hardjobovis

Spizobactin Le Vet Beheer VPA10475/032/ 1,500,000, 250 Chewable tablet - QJ51RF01 POM: - Spiramycin Generic - Oral use 1,500,000 IU / B.V. 002 international Prescription Only - Metronidazole application 250 mg unit(s)/milligram Medicine as (Article 13(1) of chewable tablets defined in Directive No for dogs relevant national 2001/82/EC) legislation

Spizobactin Le Vet Beheer VPA10475/032/ 3,000,000, 500 Chewable tablet - QJ51RF01 POM: - Spiramycin Generic - Oral use 3,000,000 IU / B.V. 003 international Prescription Only - Metronidazole application 500 mg unit(s)/milligram Medicine as (Article 13(1) of chewable tablets defined in Directive No for dogs relevant national 2001/82/EC) legislation

Spizobactin Le Vet Beheer VPA10475/032/ 750,000, 125 Chewable tablet - QJ51RF01 POM: - Spiramycin Generic - Oral use 750,000 IU / 125 B.V. 001 international Prescription Only - Metronidazole application mg chewable unit(s)/milligram Medicine as (Article 13(1) of tablets for dogs defined in Directive No relevant national 2001/82/EC) legislation

Sporimune 50 Le Vet Beheer VPA10475/004/ 50 Oral solution - QL04AA01 POM: - Ciclosporin Generic - Oral use mg/ml oral B.V. 001 milligram(s)/millil Prescription Only application solution for cats itre Medicine as (Article 13(1) of and dogs defined in Directive No relevant national 2001/82/EC) legislation

Spotinor 10 Norbrook VPA22664/118/ 10 Spot-on solution - QP53AC11 POM: - Deltamethrin Generic - Topical use mg/ml Spot-on Laboratories 001 milligram(s)/millil Prescription Only application Solution for (Ireland) Limited itre Medicine as (Article 13(1) of cattle and sheep defined in Directive No relevant national 2001/82/EC) legislation

Sputolosin Oral Boehringer VPA10454/014/ 5 Oral powder - QR05CB90 POM: - Dembrexine Full application - Oral use Powder 5 mg/g Ingelheim 001 milligram(s)/gra Prescription Only hydrochloride (Article 12(3) of Vetmedica m Medicine as monohydrate Directive No GmbH defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 172 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration STABOX 50 % Virbac S.A. VPA10988/052/ 50 percent Powder for oral - QJ01CA04 POM: - Amoxicillin Full application - Oral use w/w Powder for 002 weight/weight solution Prescription Only (Article 12(3) of Oral Solution for Medicine as Directive No Pigs defined in 2001/82/EC) relevant national legislation

Stabox 5g Virbac S.A. VPA10988/052/ 5 gram/100gram Premix for - QJ01CA04 POM: - Amoxicillin ZZZ Complete - Oral use Premix for 001 medicated Prescription Only trihydrate application medicated feeding stuff Medicine as (stand-alone) - feeding stuff defined in Council Directive relevant national 81/851/EEC legislation

Startect Dual Zoetis Belgium VPA10387/066/ 10,1 Oral solution - QP54AA52 POM: - Derquantel Full application - Oral use Active Startect S.A. 001 milligram(s)/millil Prescription Only - Abamectin (Article 12(3) of for Sheep itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

STELLAMUNE Elanco GmbH VPA22020/040/ . Emulsion for - QI09AB13 POM: - Inactivated Full application - Intramuscular MYCOPLASMA 001 injection Prescription Only mycoplasma (Article 12(3) of use Medicine as hyopneumoniae Directive No defined in (strain p-5722-3) 2001/82/EC) relevant national legislation

STENOROL Huvepharma NV VPA10782/036/ 0.5 Oral solution - QP51AX08 POM: - Halofuginone Generic - Per Oral CRYPTO 0.5 001 milligram(s)/millil Prescription Only Base (As lactate application mg/ml oral itre Medicine as salt) (Article 13(1) of solution for defined in Directive No calves relevant national 2001/82/EC) legislation

Stimovar Laboratories VPA10396/002/ 7500 Powder and - QG03GA03 POM: - Equine serum 12(3) full dossier - Intra-Muscular Injection Ovejero S.A. 001 international solvent for Prescription Only gonadotrophin - Subcutaneous unit(s) solution for Medicine as for veterinary infusion defined in use relevant national legislation

Strantel 230/20 Chanelle VPA10987/108/ 230, 20 Film-coated - QP52AA51 CAM: - Praziquantel Hybrid - Oral use mg Flavoured Pharmaceuticals 001 mg/tablet tablet Companion - Pyrantel application Film-Coated Manufacturing Animal Medicine embonate (Article 13(3) of Tablets for Cats Limited as defined in Directive No relevant national 2001/82/EC) legislation

Strantel Plus Chanelle VPA10987/082/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use Tablets for dogs Pharmaceuticals 001 mg/tablet Companion - Febantel application Manufacturing Animal Medicine - Pyrantel (Article 13(3) of Limited as defined in embonate Directive No relevant national 2001/82/EC) legislation

Strantel Plus XL Chanelle VPA10987/082/ 175,504,525 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use Tablets For Dog Pharmaceuticals 002 mg/tablet Companion - Febantel application Manufacturing Animal Medicine - Pyrantel (Article 13(3) of Limited as defined in embonate Directive No relevant national 2001/82/EC) legislation

Stresnil 40 Elanco GmbH VPA22020/007/ 40 Solution for - QN05AD90 POM: - Azaperone Full application - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use for Injection for itre Medicine as Directive No Pigs defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 173 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Suifertil 4 mg/ml aniMedica VPA10826/021/ 4.0 Oral solution - QG03DX90 POM: - Altrenogest Generic - Oral use oral solution for GmbH 001 milligram(s)/millil Prescription Only application pigs itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Suiseng Coli /C Laboratorios VPA10846/019/ . Suspension for - QI09AB08 LM: Licensed - F4ab fimbrial Full application - Intramuscular Suspension for Hipra S.A. 001 injection Merchant as adhesin of e.coli (Article 12(3) of use injection for pigs defined in - F4ac fimbrial Directive No relevant national adhesin of e.coli 2001/82/EC) legislation - 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

Suiseng Laboratorios VPA10846/010/ . Suspension for - QI09AB08 LM: Licensed - F4ab fimbrial Full application - Intramuscular Suspension for Hipra S.A. 001 injection Merchant as adhesin of e.coli (Article 12(3) of use injection for pigs defined in - F4ac fimbrial Directive No relevant national adhesin of e.coli 2001/82/EC) legislation - 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

Suivac APP ChemVet dk A/S VPA10395/001/ 1.0 - 10.0 unit(s) Emulsion for - QI09AB07 POM (E): - Actinobacillus Full application - Intramuscular emulsion for 001 injection Prescription Only pleuropneumoni (Article 12(3) of use injection for pigs Exempt as ae serotype 2, Directive No defined in strain app 2001/82/EC) relevant national 2TR98, legislation inactivated - APX I toxoid - APX II toxoid - APX III toxoid - Actinobacillus pleuropneumoni ae serotype 9, strain app 9KL97, inactivated Sulfaprex Premix LABORATORIO VPA10665/005/ 250/50 Premix for - QJ01EW10 POM: - Sulfadiazine Hybrid - Oral use for medicated S CALIER S.A. 001 milligram(s)/gra medicated Prescription Only - Trimethoprim application feeding stuff for m feeding stuff Medicine as (Article 13(3) of pigs defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 174 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Sulfoprim 15% Univet Limited VPA10990/033/ 125/25 Premix for - QJ01EW10 POM: - Trimethoprim Generic - Oral use Premix for 001 gram(s)/kilogra medicated Prescription Only - Sulfadiazine application Medicated Feed m(s) feeding stuff Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Sulfoprim 21% Univet Limited VPA10990/025/ 178.4/35.6 Premix for - QJ01EW10 POM: - Trimethoprim Generic - Oral use Premix for 001 gram(s)/kilogra medicated Prescription Only - Sulfadiazine application Medicated Feed m(s) feeding stuff Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Sulpha No.2 Chanelle VPA10987/018/ 99.01 percent Powder for oral - QJ01EQ POM: - Sulfadimidine - Oral use Powder for Oral Pharmaceuticals 001 weight/weight solution Prescription Only Solution Manufacturing Medicine as Limited defined in relevant national legislation

Sulphamet Interchem VPA10555/005/ 40, 200 Solution for - QJ01E POM: - Trimethoprim Informed - Intramuscular 40/200 Solution Ireland Ltd 001 milligram(s)/millil injection Prescription Only - Sulfadiazine consent use for Injection itre Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Sumex 1 %w/v Chanelle VPA10987/150/ 1.0 percent Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous solution for Pharmaceuticals 001 weight/volume injection Prescription Only use injection for Manufacturing Medicine as cattle Limited defined in relevant national legislation

Sumex 1% w/v Chanelle VPA10987/151/ 1 percent Solution for - QP54AA01 POM: - Ivermectin - Subcutaneous solution for Pharmaceuticals 001 weight/volume injection Prescription Only use injection for pigs Manufacturing Medicine as Limited defined in relevant national legislation

Sumex 5 mg/ml Chanelle VPA10987/160/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin Generic - Topical use Pour on Solution Pharmaceuticals 001 milligram(s)/millil Prescription Only application for Cattle Manufacturing itre Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Summer Dip Hygeia VPA10203/002/ 10 percent Concentrate for - QP53AF03 POM: - Diazinon Well-established - Dipping Concentrate for Chemicals Ltd 001 weight/volume dip emulsion Prescription Only use application dip emulsion Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Supaverm Oral Elanco GmbH VPA22020/031/ 50, 75 Oral suspension - QP52AC09 POM: - Mebendazole Fixed - Oral use Suspension 001 milligram(s)/millil - QP52AG09 Prescription Only - Closantel combination itre Medicine as sodium dihydrate application defined in (Article 13b of relevant national Directive No legislation 2001/82/EC)

Sureseal 2.6 g Norbrook VPA22664/116/ 2.6 g/syringe Intramammary - QG52X LM: Licensed - Bismuth Hybrid - Intramammary Intramammary Laboratories 001 suspension Merchant as subnitrate, heavy application use Suspension for (Ireland) Limited defined in (Article 13(3) of Cattle relevant national Directive No legislation 2001/82/EC)

Surolan Ear Elanco GmbH VPA22020/032/ 23, 5, 0.529 Cutaneous - QD01AC52 POM: - Miconazole - Auricular use Drops and 001 milligram(s)/millil suspension Prescription Only nitrate - Topical use Cutaneous itre Medicine as - Prednisolone Suspension defined in acetate relevant national - Polymyxin B legislation sulfate

Veterinary Medicines Authorised/Transfer Pending Products Page 175 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Surricoxx 400 V.M.D. n.v/s.a. VPA10817/004/ 400 Solution for use - QP51AX09 POM: - Amprolium (as Hybrid - In drinking mg/ml Solution 001 milligram(s)/millil in drinking water Prescription Only hydrochloride) application water use for use in itre Medicine as (Article 13(3) of drinking water for defined in Directive No chickens, relevant national 2001/82/EC) turkeys, ducks legislation and guinea fowls

Suvaxyn M Hyo Zoetis Belgium VPA10387/067/ . Suspension for - QI09AB13 LM: Licensed - Inactivated Full application - Intramuscular Suspension for S.A. 001 injection Merchant as mycoplasma (Article 12(3) of use injection for pigs defined in hyopneumoniae Directive No relevant national 2001/82/EC) legislation

Suvaxyn M.hyo - Zoetis Belgium VPA10387/068/ . Suspension for - QI09AB17 LM: Licensed - Inactivated Full application - Intramuscular Parasuis, S.A. 001 injection Merchant as mycoplasma (Article 12(3) of use suspension for defined in hyopneumoniae Directive No injection for pigs relevant national (strain p-5722-3) 2001/82/EC) legislation - Inactivated haemophilus parasuis serovar 4, strain 2170b - Inactivated haemophilus parasuis serovar 5, strain ia84- 29755

Suvaxyn MH- Zoetis Belgium VPA10387/069/ . Relative Emulsion for - QI09AB13 LM: Licensed - Mycoplasma Full application - Intramuscular One Emulsion S.A. 001 potency injection Merchant as hyopneumoniae, (Article 12(3) of use for injection for defined in inactivated, Directive No pigs relevant national strain p-5722-3 2001/82/EC) legislation

Sympagesic 500 Dechra VPA22622/033/ 500, 4 Solution for - QA03DB04 POM: - Metamizole Generic - Intramuscular mg/ml + 4 mg/ml Regulatory B.V. 001 milligram(s)/millil injection Prescription Only sodium application use solution for itre Medicine as monohydrate (Article 13(1) of - Intravenous injection for defined in - Hyoscine Directive No use horses, cattle, relevant national butylbromide 2001/82/EC) pigs and dogs legislation

Syncrostim 500 Ceva Santé VPA10815/015/ 500 international Lyophilisate and - QG03GA01 POM: - Gonadotrophin Generic - Intramuscular IU lyophilisate Animale 001 unit(s) solvent for Prescription Only equine serum application use and solvent for solution for Medicine as (ecg) (Article 13(1) of solution for injection defined in Directive No injection for relevant national 2001/82/EC) cattle and sheep legislation

Synthadon 10 Le Vet Beheer VPA10475/011/ 10 Solution for - QN02AC52 VPO: Veterinary - Methadone Generic - Intramuscular mg/ml solution B.V. 002 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for itre as defined in (Article 13(1) of - Intravenous cats and dogs relevant national Directive No use legislation 2001/82/EC) - Subcutaneous use

Synulox Bolus Zoetis Belgium VPA10387/072/ 400,100 Coated tablet - QJ01CR02 POM: - Amoxicillin Full application - Oral use 500 mg S.A. 001 mg/tablet Prescription Only trihydrate (Article 12(3) of Medicine as - Potassium Directive No defined in clavulanate 2001/82/EC) relevant national legislation

Synulox Zoetis Belgium VPA10387/073/ 200, 50, 10 Intramammary - QJ51RV01 POM: - Amoxicillin Full application - Intramammary Lactating Cow S.A. 001 mg/syringe suspension Prescription Only trihydrate (Article 12(3) of use Intramammary Medicine as - Prednisolone Directive No suspension. defined in - Potassium 2001/82/EC) relevant national clavulanate legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 176 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Synulox Zoetis Belgium VPA10387/074/ 200,50 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin Known active - Oral use Palatable S.A. 002 Prescription Only trihydrate substance Tablets 250 mg Medicine as - Potassium (Article 12(3) of defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Synulox Zoetis Belgium VPA10387/074/ 40,10 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin Known active - Oral use Palatable S.A. 001 Prescription Only trihydrate substance Tablets 50 mg Medicine as - Potassium (Article 12(3) of defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Synulox Ready Zoetis Belgium VPA10387/075/ 140,35 Suspension for - QJ01CR02 POM: - Amoxicillin Known active - Intramuscular to Use Injection S.A. 001 milligram(s)/millil injection Prescription Only trihydrate substance use itre Medicine as - Potassium (Article 12(3) of - Subcutaneous defined in clavulanate Directive No use relevant national 2001/82/EC) legislation

Synulox Ready Zoetis Belgium VPA10387/075/ 140, 35 Suspension for - QJ01CR02 POM: - Amoxicillin Known active - Intramuscular To Use Injection S.A. 002 milligram(s)/millil injection Prescription Only - Clavulanic acid substance use itre Medicine as (Article 12(3) of - Subcutaneous defined in Directive No use relevant national 2001/82/EC) legislation

SynVet-50; 50 Equimed VPA22694/001/ 50 mg/syringe Solution for - QM09AX01 VPO: Veterinary - Sodium Well-established - Intraarticular mg solution for Pharma Ltd 001 injection Practitioner Only hyaluronate use application use injection for as defined in (Article 13a of horses relevant national Directive No legislation 2001/82/EC)

TAF SPRAY Eurovet Animal VPA10989/063/ 28.5 Cutaneous - QD06AX POM: - Thiamphenicol Generic - Topical use 28.5 mg/g Health B.V. 001 milligram(s)/gra spray, solution Prescription Only application Cutaneous m Medicine as (Article 13(1) of Spray, Solution defined in Directive No relevant national 2001/82/EC) legislation

Taneven LC 3 g WDT - VPA10660/004/ 3 gram(s) Intramammary - QJ51CE09 POM: - Benzylpenicillin Generic - Intramammary intramammary Wirtschaftsgeno 001 suspension Prescription Only Procaine application use suspension for ssenschaft Medicine as Monohydrate (Article 13(1) of cattle deutscher defined in Directive No Tierarzte eG relevant national 2001/82/EC) legislation

Taurador 5 Norbrook VPA22664/111/ 5 Pour-on solution - QP54AA03 POM: - Doramectin Generic - Topical use mg/ml Pour-on Laboratories 001 milligram(s)/millil Prescription Only application Solution for (Ireland) Limited itre Medicine as (Article 13(1) of Cattle defined in Directive No relevant national 2001/82/EC) legislation

Tauramox 5 Norbrook VPA22664/130/ 5 Pour-on solution - QP54AB02 POM: - Moxidectin Generic - Topical use mg/ml Pour-On Laboratories 001 milligram(s)/millil Prescription Only application Solution for (Ireland) Limited itre Medicine as (Article 13(1) of Cattle defined in Directive No relevant national 2001/82/EC) legislation

Temprace 0.5 Le Vet Beheer VPA10475/033/ 0.5 Solution for - QN05AA04 VPO: Veterinary - Acepromazine Hybrid - Intravenous mg/ml solution B.V. 001 milligram(s)/millil injection Practitioner Only application use for injection for itre as defined in (Article 13(3) of dogs and cats relevant national Directive No legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 177 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Terramycin Zoetis Belgium VPA10387/076/ 4 gram(s)/150 Cutaneous - QD06AA03 POM: - Oxytetracycline Full application - Topical use Aerosol Spray S.A. 001 millilitre spray, Prescription Only hydrochloride (Article 12(3) of suspension Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Terramycin LA Zoetis Belgium VPA10387/077/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Full application - Intramuscular 200 mg/ml S.A. 001 milligram(s)/millil injection Prescription Only dihydrate (Article 12(3) of use Solution for itre Medicine as Directive No - Intravenous Injection defined in 2001/82/EC) use relevant national - Subcutaneous legislation use

Terrexine DC Univet Limited VPA10990/052/ 250 mg/syringe Intramammary - QJ51DB90 POM: - Cefalonium Hybrid - Intramammary 250 mg 001 suspension Prescription Only dihydrate application use Intramammary Medicine as (Article 13(3) of Suspension for defined in Directive No Dry Cows relevant national 2001/82/EC) legislation

Terrexine LC Univet Limited VPA10990/023/ . Intramammary - QJ51 POM: - Kanamycin Full application - Intramammary Intramammary 001 suspension Prescription Only monosulphate (Article 12(3) of use Suspension for Medicine as - Cefalexin Directive No lactating cows defined in monohydrate 2001/82/EC) relevant national legislation

Tetanus Intervet Ireland VPA10996/150/ . Solution for - QI04AM02 POM: - Equine serum Full application - Intramuscular Antitoxin Behring Limited 001 injection - QI05AM01 Prescription Only protein (Article 12(3) of use - QI07AM Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national - Subcutaneous legislation use - ZZZ Intra-spinal

Tetracure 200 Bimeda Animal VPA22033/068/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Generic - Intramuscular mg/ml solution Health Limited 001 milligram(s)/millil injection Prescription Only dihydrate application use for injection for itre Medicine as (Article 13(1) of cattle, sheep and defined in Directive No pigs relevant national 2001/82/EC) legislation

Tetra-Delta Zoetis Belgium VPA10387/078/ 105,100,100,10 Intramammary - QJ51RV01 POM: - Neomycin Full application - Intramammary Milking Cow S.A. 001 0,10 milligram/ suspension Prescription Only sulphate (Article 12(3) of use 10 millilitre Medicine as - Procaine Directive No defined in benzylpenicillin 2001/82/EC) relevant national - Novobiocin legislation sodium - Dihydrostreptom ycin sulphate - Prednisolone Tetroxy 10 % Bimeda Animal VPA22033/032/ 10 percent Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular Solution for Health Limited 001 weight/volume injection Prescription Only Hydrochloride consent use Injection for Medicine as application cattle, sheep and defined in (Article 13c of pigs relevant national Directive No legislation 2001/82/EC)

Tetroxy LA 200 Bimeda Animal VPA22033/044/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Well-established - Intramuscular mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only use application use for Injection itre Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Therios 300 mg Ceva Santé VPA10815/033/ 300 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use palatable tablets Animale 002 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 178 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Therios 75 mg Ceva Santé VPA10815/033/ 75 mg/tablet Chewable tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use Chewable Animale 001 Prescription Only application Tablets for Cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Therios 750 mg Ceva Santé VPA10815/033/ 750 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Hybrid - Oral use palatable tablets Animale 003 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Thiafeline 2.5 mg Le Vet Beheer VPA10475/006/ 2.5 mg/tablet Film-coated - QH03BB02 POM: - Thiamazole Generic - Oral use Film-coated B.V. 001 tablet Prescription Only application Tablets for Cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Thiafeline 5 mg Le Vet Beheer VPA10475/006/ 5 mg/tablet Film-coated - QH03BB02 POM: - Thiamazole Generic - Oral use Film-coated B.V. 002 tablet Prescription Only application Tablets for Cats Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Thyforon Eurovet Animal VPA10989/060/ 200 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Generic - Oral use flavoured 200 Health B.V. 001 Prescription Only sodium application microgram Medicine as (Article 13(1) of tablets for dogs defined in Directive No relevant national 2001/82/EC) legislation

Thyforon Eurovet Animal VPA10989/060/ 400 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Generic - Oral use flavoured 400 Health B.V. 002 Prescription Only sodium application microgram Medicine as (Article 13(1) of tablets for dogs defined in Directive No relevant national 2001/82/EC) legislation

Thyforon Eurovet Animal VPA10989/060/ 600 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Hybrid - Oral use flavoured 600 Health B.V. 003 Prescription Only sodium application microgram Medicine as (Article 13(3) of tablets for dogs defined in Directive No relevant national 2001/82/EC) legislation

Thyforon Eurovet Animal VPA10989/060/ 800 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Hybrid - Oral use flavoured 800 Health B.V. 004 Prescription Only sodium application microgram Medicine as (Article 13(3) of tablets for dogs defined in Directive No relevant national 2001/82/EC) legislation

Thyronorm 5 Norbrook VPA22664/127/ 5 Oral solution - QH03BB02 POM: - Thiamazole Hybrid - Oral use mg/ml Oral Laboratories 001 milligram(s)/millil Prescription Only application Solution for Cats (Ireland) Limited itre Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Thyroxanil 200 Le Vet Beheer VPA10475/023/ 200 Tablet - QH03AA01 POM: - Levothyroxine Generic - Oral use microgram B.V. 001 microgram(s) Prescription Only sodium application tablets for dogs Medicine as (Article 13(1) of and cats defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 179 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Thyroxanil 600 Le Vet Beheer VPA10475/023/ 600 Tablet - QH03AA01 POM: - Levothyroxine Generic - Oral use microgram B.V. 002 microgram(s) Prescription Only sodium application tablets for dogs Medicine as (Article 13(1) of and cats defined in Directive No relevant national 2001/82/EC) legislation

Tialin 125 mg/ml Dechra VPA22622/019/ 125 Solution for use - QJ01XQ01 POM: - Tiamulin Generic - In drinking solution for use Regulatory B.V. 001 milligram(s)/millil in drinking water Prescription Only hydrogen application water use in drinking water itre Medicine as fumarate (Article 13(1) of for pigs, defined in Directive No chickens and relevant national 2001/82/EC) turkeys legislation

Tialin 250 mg/ml Dechra VPA22622/019/ 250 Solution for use - QJ01XQ01 POM: - Tiamulin Generic - In drinking solution for use Regulatory B.V. 002 milligram(s)/millil in drinking water Prescription Only hydrogen application water use in drinking water itre Medicine as fumarate (Article 13(1) of for pigs, defined in Directive No chickens and relevant national 2001/82/EC) turkeys legislation

Tilmodil 300 Emdoka bvba VPA10534/002/ 300 Solution for - QJ01FA91 VPO: Veterinary - Tilmicosin Generic - Subcutaneous mg/ml Solution 001 milligram(s)/millil injection Practitioner Only application use for Injection for itre as defined in (Article 13(1) of cattle and sheep relevant national Directive No legislation 2001/82/EC)

Tilmovet 100 Huvepharma NV VPA10782/004/ 100 Premix for - QJ01FA91 POM: - Tilmicosin Generic - Oral use g/kg Premix for 002 gram(s)/kilogra medicated Prescription Only application medicated m(s) feeding stuff Medicine as (Article 13(1) of feeding stuff for defined in Directive No pigs and rabbits relevant national 2001/82/EC) legislation

Tilmovet 100 Huvepharma NV VPA10782/011/ 100 Granules - QJ01FA91 POM: - Tilmicosin - Oral use mg/g oral 001 milligram(s)/gra Prescription Only granules for pigs m Medicine as defined in relevant national legislation

Tilmovet 200 Huvepharma NV VPA10782/004/ 200 Premix for - QJ01FA91 POM: - Tilmicosin Generic - Oral use g/kg Premix for 001 gram(s)/kilogra medicated Prescription Only application medicated m(s) feeding stuff Medicine as (Article 13(1) of feeding stuff for defined in Directive No pigs and rabbits relevant national 2001/82/EC) legislation

Tilmovet 250 Huvepharma NV VPA10782/003/ 250 Oral solution - QJ01FA91 POM: - Tilmicosin Generic - Oral use mg/ml 001 milligram(s)/millil Prescription Only application Concentrate for itre Medicine as (Article 13(1) of Oral Solution for defined in Directive No pigs, chickens, relevant national 2001/82/EC) turkeys and legislation cattle (calves)

Tilmovet 300 Huvepharma NV VPA10782/032/ 300 Solution for - QJ01FA91 VPO: Veterinary - Tilmicosin Generic - Subcutaneous mg/ml Solution 001 milligram(s)/millil injection Practitioner Only application use for Injection for itre as defined in (Article 13(1) of cattle and sheep relevant national Directive No legislation 2001/82/EC)

Tilmovet 40 g/kg Huvepharma NV VPA10782/004/ 40 Premix for - QJ01FA91 POM: - Tilmicosin - Oral use Premix for 003 gram(s)/kilogra medicated Prescription Only medicated m(s) feeding stuff Medicine as feeding stuff for defined in pigs and rabbits relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 180 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Tizoval 6 mg/g ECO Animal VPA22693/012/ 6 Premix for - QP54AA01 POM: - Ivermectin Informed - Oral use Premix for Health Europe 001 milligram(s)/gra medicated Prescription Only consent medicated Limited m feeding stuff Medicine as application feeding stuff for defined in (Article 13c of pigs relevant national Directive No legislation 2001/82/EC)

Tolfedine 4% w/v Vetoquinol VPA10983/019/ 4 percent Solution for - QM01AG02 POM: - Tolfenamic acid - Intramuscular Solution for Ireland Limited 001 weight/volume injection Prescription Only use Injection for dogs Medicine as - Subcutaneous and cats defined in use relevant national legislation

Tolfedine 6 mg Vetoquinol VPA10983/018/ 6 mg/tablet Tablet - QM01AG02 POM: - Tolfenamic acid - Oral use tablets Ireland Limited 001 Prescription Only Medicine as defined in relevant national legislation

Tolfedine 60 mg Vetoquinol VPA10983/018/ 60 mg/tablet Tablet - QM01AG02 POM: - Tolfenamic acid - Oral use tablets Ireland Limited 002 Prescription Only Medicine as defined in relevant national legislation

TOLFEDOL, 40 SP Veterinaria, VPA10790/006/ 40 Solution for - QM01AG02 POM: - Tolfenamic acid Generic - Intramuscular mg/ml, solution S.A. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, pigs, cats defined in Directive No use and dogs relevant national 2001/82/EC) - Subcutaneous legislation use

Tolfine Vetoquinol VPA10983/031/ 40 Solution for - QM01AG02 POM: - Tolfenamic acid Full application - Intramuscular Ireland Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use itre Medicine as Directive No - Intravenous defined in 2001/82/EC) use relevant national legislation

Tolracol 50 Krka, d.d., Novo VPA10774/026/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml oral mesto 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(1) of pigs, cattle and defined in Directive No sheep relevant national 2001/82/EC) legislation

Toltarox 50 Krka, d.d., Novo VPA10774/007/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml oral mesto 002 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(1) of cattle defined in Directive No relevant national 2001/82/EC) legislation

Toltarox 50 Krka, d.d., Novo VPA10774/007/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use mg/ml oral mesto 001 milligram(s)/millil Prescription Only application suspension for itre Medicine as (Article 13(1) of pigs defined in Directive No relevant national 2001/82/EC) legislation

TOPIMEC 0.8 Chanelle VPA10987/080/ 0.8 Oral solution - QP54AA01 POM: - Ivermectin Hybrid - Oral use mg/ml Oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application Solution for Manufacturing itre Medicine as (Article 13(3) of Sheep Limited defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 181 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Topimec 5 mg/ml Chanelle VPA10987/159/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin Generic - Topical use Pour-on Solution Pharmaceuticals 001 milligram(s)/millil Prescription Only application Manufacturing itre Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Topimec Chanelle VPA10987/157/ 10 Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous Injection 10 Pharmaceuticals 001 milligram(s)/millil injection Prescription Only application use mg/ml solution Manufacturing itre Medicine as (Article 13(1) of for injection Limited defined in Directive No relevant national 2001/82/EC) legislation

Topimec Super Chanelle VPA10987/099/ 10, 100 Solution for - QP54AA51 POM: - Ivermectin Generic - Subcutaneous Solution for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only - Clorsulon application use Injection Manufacturing itre Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Torbugesic 10 Zoetis Belgium VPA10387/079/ 10 Solution for - QN02AF01 POM: - Butorphanol - Intramuscular mg/ml Solution S.A. 001 milligram(s)/millil injection Prescription Only Tartrate use for Injection itre Medicine as - Intravenous defined in use relevant national - Subcutaneous legislation use

Torbuphanol Vet Zoetis Belgium VPA10387/080/ 10 Solution for - QN02AF01 POM: - Butorphanol - Intramuscular 10 mg/ml S.A. 001 milligram(s)/millil injection Prescription Only tartrate use solution for itre Medicine as - Intravenous injection for defined in use injection for relevant national - Subcutaneous horses, dogs and legislation use cats Torphadine 10 Le Vet Beheer VPA10475/038/ 10 Solution for - QN02AF01 POM: - Butorphanol Generic - Intramuscular mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous dogs, cats and defined in Directive No use horses relevant national 2001/82/EC) - Subcutaneous legislation use

Toxovax Intervet Ireland VPA10996/080/ . Concentrate for - QI04AN01 POM: - Toxoplasma Full application - Intramuscular Limited 001 solution for Prescription Only gondii (Article 12(3) of use injection Medicine as tachyzoites s48 Directive No defined in 2001/82/EC) relevant national legislation

Tralieve 20 mg Le Vet Beheer VPA10475/036/ 20 mg/tablet Chewable tablet - QN02AX02 POM: - Tramadol Hybrid - Oral use chewable tablets B.V. 001 Prescription Only hydrochloride application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Tralieve 50 Le Vet Beheer VPA10475/034/ 50 Solution for - QN02AX02 VPO: Veterinary - Tramadol Generic - Intramuscular mg/ml solution B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for itre as defined in (Article 13(1) of - Intravenous dogs relevant national Directive No use legislation 2001/82/EC)

Tralieve 80 mg Le Vet Beheer VPA10475/036/ 80 mg/tablet Chewable tablet - QN02AX02 POM: - Tramadol Hybrid - Oral use chewable tablets B.V. 002 Prescription Only hydrochloride application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 182 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Tramadog 50 Domes Pharma VPA10386/001/ 50 Solution for - QN02AX02 VPO: Veterinary - Tramadol Generic - Intramuscular mg/ml solution SC 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for itre as defined in (Article 13(1) of - Intravenous dogs relevant national Directive No use legislation 2001/82/EC)

Tramazole 10% Univet Limited VPA10990/038/ 10 percent Oral suspension - QP52AC11 POM: - Albendazole Generic - Oral use Oral Drench 002 weight/volume Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Tramazole 2.5% Univet Limited VPA10990/038/ 2.5 percent Oral suspension - QP52AC11 POM: - Albendazole Generic - Oral use Oral Drench 001 weight/volume Prescription Only application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Tramvetol 50 mg Virbac S.A. VPA10988/111/ 50 mg/tablet Tablet - QN02AX02 POM: - Tramadol Generic - Oral use tablets for dogs 001 Prescription Only hydrochloride application Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Tramvetol 50 Virbac S.A. VPA10988/112/ 50 Solution for - QN02AX02 VPO: Veterinary - Tramadol Generic - Intramuscular mg/ml solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use for injection for itre as defined in (Article 13(1) of - Intravenous dogs relevant national Directive No use legislation 2001/82/EC)

Tranquiline 35 Floris Veterinaire VPA10492/001/ 35 Oral gel - QN05AA04 POM: - Acepromazine Generic - Oral use mg/ml Oral Gel Produkten BV 001 milligram(s)/millil Prescription Only maleate application for Dogs itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Tratol 50 mg/ml Krka, d.d., Novo VPA10774/011/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use oral suspension mesto 001 milligram(s)/millil Prescription Only application for pigs, cattle itre Medicine as (Article 13(1) of and sheep defined in Directive No relevant national 2001/82/EC) legislation

Triazole Fluke Pharvet (Ireland) VPA10462/001/ 15.0, 22.5 Oral suspension - QP52AE51 POM: - Levamisole Informed - Oral use and Worm Ltd 001 milligram(s)/millil Prescription Only hydrochloride consent Drench itre Medicine as - Rafoxanide application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Tribex 10 % Oral Chanelle VPA10987/146/ 10 percent Oral suspension - QP52AC01 POM: - Triclabendazole Generic - Oral use Suspension for Pharmaceuticals 002 weight/volume Prescription Only application Cattle Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Tribex 5 % Oral Chanelle VPA10987/146/ 5 percent Oral suspension - QP52AC01 POM: - Triclabendazole Well-established - Oral use Suspension for Pharmaceuticals 001 weight/volume Prescription Only use application Sheep Manufacturing Medicine as (Article 13a of Limited defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 183 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Tribovax 10 Intervet Ireland VPA10996/259/ . Suspension for - QI02AB01 LM: Licensed - C. perfringens - Subcutaneous suspension for Limited 001 injection - QI04AB01 Merchant as type a toxoid use injection for defined in (strain cn 1491) cattle and sheep relevant national - C. perfringens legislation type b toxoid (strain cn 1240) - C. perfringens type c toxoid (strain cn 883) - C. chauvoei whole culture (strain cn 3796) - C. novyi type b toxoid (strain cn 6120) - C. septicum toxoid (strain cn 368) - C. tetani toxoid (strain cn 3911) - C. sordellii toxoid (strain 831) - C. haemolyticum toxoid (strain cn 3629) - C. perfringens type d toxoid (strain cn 3688) - C. perfringens type B&C (ß) toxoid - C. perfringens type D (e) toxoid - C. chauvoei whole culture - C. novyi toxoid - C. septicum toxoid - C. tetani toxoid - C. sordellii toxoid - C. haemolyticum - C. perfringens type a (alpha) toxoid

Veterinary Medicines Authorised/Transfer Pending Products Page 184 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Tribovax Intervet Ireland VPA10996/286/ . Suspension for - QI02AB01 LM: Licensed - Clostridium Full application - Subcutaneous suspension for Limited 001 injection Merchant as Perfringens Type (Article 12(3) of use injection for defined in A, Alfa Toxoid Directive No cattle and sheep relevant national - CLOSTRIDIUM 2001/82/EC) legislation 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 HAEMOLYTICU M, TOXOID

Tribovax T Intervet Ireland VPA10996/260/ . Suspension for - QI02AB01 LM: Licensed - C. chauvoei Full application - Subcutaneous Limited 001 injection Merchant as - C. (Article 12(3) of use defined in haemolyticum Directive No relevant national - C. 2001/82/EC) legislation haemolyticum cells - C.noyvi B - C. noyvi B cells - C.septicum CN3204 (3U/ml) - C.septicum CN368(7U/ml) - C.tetani

Tricaine PHARMAQ AS VPA10804/006/ 1000 Powder for - QN01AX93 POM: - Tricaine Generic - Water-borne Pharmaq 1000 001 milligram(s)/gra solution for fish Prescription Only methane application use mg/g Powder for m treatment Medicine as sulfonate (Article 13(1) of Solution for Fish defined in Directive No Treatment relevant national 2001/82/EC) legislation

Triclaben 10% Chanelle VPA10987/059/ 10 percent Oral suspension - QP52AC POM: - Triclabendazole Generic - Oral use Oral Suspension Pharmaceuticals 001 Prescription Only application for Cattle Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Triclaben 5% Chanelle VPA10987/058/ 5 percent Oral suspension - QP52AC POM: - Triclabendazole Generic - Oral use Oral Suspension Pharmaceuticals 001 weight/volume Prescription Only application for Sheep Manufacturing Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 185 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Trigoderm Gel Dechra VPA10803/002/ 0.5, 0.1 percent Gel - QD07CC01 POM: - Fusidic acid ZZZ Complete - Topical use 0.5 % w/w Veterinary 001 weight/weight Prescription Only - Betamethasone application Fusidic acid, 0.1 Products A/S Medicine as valerate (stand-alone) - % w/w defined in Council Directive Betamethasone relevant national 81/851/EEC legislation

Trimectin 1.0% Bimeda Animal VPA22033/069/ 1.0 percent Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous w/v Solution for Health Limited 001 weight/volume injection Prescription Only application use Injection Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Trimediazine Vetoquinol VPA10983/058/ 12.5/2.5 percent Premix for - QJ01EW10 POM: - Sulfadiazine - Oral use 15% Premix for Ireland Limited 001 weight/weight medicated Prescription Only - Trimethoprim medicated feeding stuff Medicine as feeding stuff defined in relevant national legislation

Trimediazine Vetoquinol VPA10983/059/ 5.0 / 25.0 Oral powder - QJ01EW10 POM: - Trimethoprim Full application - Oral use Plain Oral Ireland Limited 001 percent Prescription Only - Sulfadiazine (Article 12(3) of Powder weight/weight Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Trioxyl 500 mg/g Univet Limited VPA10990/048/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Informed - In drinking powder for use in 001 milligram(s)/gra in drinking water Prescription Only trihydrate consent water use drinking water for m Medicine as application chickens, defined in (Article 13c of turkeys, ducks relevant national Directive No and pigs legislation 2001/82/EC)

Trioxyl LA Univet Limited VPA10990/010/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin ZZZ Informed - Intramuscular 150mg/ml 001 milligram(s)/millil injection Prescription Only trihydrate consent use Suspension for itre Medicine as (abridged Injection defined in application) - relevant national Council Directive legislation 81/851/EEC

Trippel-Oxy 150 Univet Limited VPA10990/037/ 150 Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only hydrochloride use for Injection. itre Medicine as defined in relevant national legislation

TRIVACTON 6 Boehringer VPA10454/076/ . Suspension for - QI02AL01 LM: Licensed - Inactivated Full application - Subcutaneous Ingelheim 001 injection Merchant as bovine (Article 12(3) of use Vetmedica defined in coronavirus Directive No GmbH relevant national strain f15 2001/82/EC) legislation - Inactivated bovine rotavirus strain ro1 - Inactivated e.coli k99 strain serotype o101 - Inactivated e.coli y strain serotype o117 - Inactivated e.coli f41 strain serotype o101 - Inactivated e. coli 31a strain serotype O78 Trodax 340 Boehringer VPA10454/077/ 340 Solution for - QP52AG08 POM: - Nitroxynil Full application - Subcutaneous mg/ml Solution Ingelheim 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use for Injection Vetmedica itre Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 186 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Troscan 100 mg Chanelle VPA10987/141/ 100 mg/tablet Film-coated - QP52AX01 CAM: - Nitroscanate Well-established - Oral use film coated tablet Pharmaceuticals 001 tablet Companion use application for Dogs Manufacturing Animal Medicine (Article 13a of Limited as defined in Directive No relevant national 2001/82/EC) legislation

Troscan 500 mg Chanelle VPA10987/141/ 500 mg/tablet Film-coated - QP52AX01 CAM: - Nitroscanate Well-established - Oral use film coated tablet Pharmaceuticals 002 tablet Companion use application for Dogs Manufacturing Animal Medicine (Article 13a of Limited as defined in Directive No relevant national 2001/82/EC) legislation

TROXXAN 100 Laboratorios VPA10495/008/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular mg/ml solution SYVA, S.A.U 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle, pigs and defined in Directive No use sheep relevant national 2001/82/EC) legislation

Trymox LA 150 Univet Limited VPA10990/051/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin Generic - Intramuscular mg/ml 001 milligram(s)/millil injection Prescription Only trihydrate application use Suspension for itre Medicine as (Article 13(1) of - Subcutaneous Injection for defined in Directive No use Cattle, Sheep, relevant national 2001/82/EC) Pigs, Dogs and legislation Cats Tsefalen 1000 I.C.F. Srl VPA10479/001/ 1000 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use mg film-coated Industria 002 Prescription Only application tablets for dogs Chimica Fine Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Tsefalen 50 I.C.F. Srl VPA10479/001/ 50 Powder for oral - QJ01DB01 POM: - Cefalexin Generic - Oral use mg/ml Powder Industria 003 milligram(s)/millil suspension Prescription Only application for Oral Chimica Fine itre Medicine as (Article 13(1) of Suspension for defined in Directive No Dogs up to 20 kg relevant national 2001/82/EC) and Cats legislation

Tsefalen 500 mg I.C.F. Srl VPA10479/001/ 500 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use film-coated Industria 001 Prescription Only application tablets for dogs Chimica Fine Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Tuberculin PPD Prionics Lelystad VPA10526/001/ . Solution for - QI02AR01 VPO-1: - Avian Full application - Intradermal use Kit - B.V. 001 injection - QI02AR02 Veterinary tuberculin PPD (Article 12(3) of Practitioner Only - Bovine Directive No as defined in tuberculin PPD 2001/82/EC) relevant national legislation

TUDOMAX, 10 SP Veterinaria, VPA10790/011/ 10 Oral powder - QR05CB02 POM: - Bromhexine Hybrid - Oral use mg/g, powder for S.A. 001 milligram(s)/gra Prescription Only application use in drinking m Medicine as (Article 13(3) of water/milk defined in Directive No relevant national 2001/82/EC) legislation

Tulaxa 100 Krka, d.d., Novo VPA10774/058/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle, pigs and defined in Directive No use sheep relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 187 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Tulaxa 25 mg/ml Krka, d.d., Novo VPA10774/058/ 25 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular solution for mesto 002 milligram(s)/millil injection Prescription Only application use injection for pigs itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Tulieve 100 Norbrook VPA22664/146/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular mg/ml solution Laboratories 001 milligram(s)/millil injection Prescription Only application use for injection for (Ireland) Limited itre Medicine as (Article 13(1) of - Subcutaneous cattle, pigs and defined in Directive No use sheep relevant national 2001/82/EC) legislation

Tullavis 100 LIVISTO Int'l, VPA10425/014/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular mg/ml solution S.L. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle, pigs and defined in Directive No use sheep relevant national 2001/82/EC) legislation

Tullavis 25 LIVISTO Int'l, VPA10425/013/ 25 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular mg/ml solution S.L. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of pigs defined in Directive No relevant national 2001/82/EC) legislation

Tuloxxin 100 Krka, d.d., Novo VPA10774/057/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Subcutaneous cattle, pigs and defined in Directive No use sheep relevant national 2001/82/EC) legislation

Tuloxxin 25 Krka, d.d., Novo VPA10774/057/ 25 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular mg/ml solution mesto 002 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of pigs defined in Directive No relevant national 2001/82/EC) legislation

TUR-3 emulsion Boehringer VPA10454/078/ . Emulsion for - QI01CA02 POM: - Inactivated Full application - Intramuscular for injection for Ingelheim 001 injection Prescription Only newcastle (Article 12(3) of use turkeys Vetmedica Medicine as disease virus Directive No GmbH defined in - Paramyxovirus 2001/82/EC) relevant national 3, inactivated legislation - Inactivated turkey rhinotracheitis virus

Turbomec Bimeda Animal VPA22033/070/ 1 percent Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous Injection for Health Limited 001 weight/volume injection Prescription Only application use Cattle and Medicine as (Article 13(1) of Sheep, 1% w/v defined in Directive No Solution for relevant national 2001/82/EC) Injection legislation

Twinox 200 Krka, d.d., Novo VPA10774/072/ 200,50 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use mg/50 mg mesto 002 Prescription Only trihydrate application chewable tablets Medicine as - Potassium (Article 13(1) of for cats and dog defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Twinox 40 mg/10 Krka, d.d., Novo VPA10774/072/ 40,10 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use mg chewable mesto 001 Prescription Only trihydrate application tablets for cats Medicine as - Potassium (Article 13(1) of and dogs defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 188 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Twinox 400 Krka, d.d., Novo VPA10774/072/ 400,100 Chewable tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use mg/100 mg mesto 003 mg/tablet Prescription Only trihydrate application chewable tablets Medicine as - Potassium (Article 13(3) of for dogs defined in clavulanate Directive No relevant national 2001/82/EC) legislation

Tylan 200, 200 Elanco GmbH VPA22020/033/ 200 Solution for - QJ01FA90 POM: - Tylosin Full application - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use for Injection itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Tylan G250 Elanco GmbH VPA22020/034/ 250 Premix for - QJ01FA90 POM: - Tylosin ZZZ Complete - Oral use Premix for 002 gram(s)/kilogra medicated Prescription Only phosphate application medicated m(s) feeding stuff Medicine as (stand-alone) - feeding stuff defined in Council Directive relevant national 81/851/EEC legislation

Tylan G50 Elanco GmbH VPA22020/034/ 50 Premix for - QJ01FA90 POM: - Tylosin ZZZ Complete - Oral use Premix for 003 gram(s)/kilogra medicated Prescription Only phosphate application medicated m(s) feeding stuff Medicine as (stand-alone) - feedingstuff defined in Council Directive relevant national 81/851/EEC legislation

Tylan Soluble Elanco GmbH VPA22020/020/ 100 gram(s) Powder for oral - QJ01FA90 POM: - Tylosin (as - Oral use Powder for Oral 001 solution Prescription Only tylosin tartrate) Solution Medicine as defined in relevant national legislation

Tyljet 200 mg/ml Ceva Santé VPA10815/055/ 200 Solution for - QJ01FA90 POM: - Tylosin Generic - Intramuscular solution for Animale 001 milligram(s)/millil injection Prescription Only application use injection for itre Medicine as (Article 13(1) of - Intravenous cattle, sheep, defined in Directive No use goats and pigs relevant national 2001/82/EC) legislation

Tylo 200 mg/ml Kela n.v. VPA10981/004/ 200 Solution for - QJ01FA90 POM: - Tylosin Tartrate ZZZ Informed - Intramuscular solution for 001 milligram(s)/millil injection Prescription Only consent use injection itre Medicine as (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

Tylosin 20 % Alfasan VPA10980/005/ 20 percent Solution for - QJ01FA90 POM: - Tylosin Tartrate ZZZ Informed - Intramuscular Solution for Nederland B.V 001 weight/volume injection Prescription Only consent use Injection Medicine as (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

TYLOSIN BIOVET Joint VPA10464/001/ 200,000 Solution for - QJ01FA90 POM: - Tylosin Generic - Intramuscular BIOVET JSC Stock Company 001 international injection Prescription Only application use 200 mg/ml unit(s)/millilitre Medicine as (Article 13(1) of - Intravenous solution for defined in Directive No use injection for relevant national 2001/82/EC) cattle, sheep, legislation goats and pigs Tylucyl 200 Vetoquinol VPA10983/060/ 200 Solution for - QJ01FA90 POM: - Tylosin Generic - Intramuscular mg/ml solution Ireland Limited 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 189 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Ubrolexin Boehringer VPA10454/016/ 200 mg/100,000 Intramammary - QJ51RD01 POM: - Cefalexin Well-established - Intramammary intramammary Ingelheim 001 IU per syringe suspension Prescription Only monohydrate use application use suspension for Vetmedica Medicine as - Kanamycin (Article 13a of lactating dairy GmbH defined in monosulphate Directive No cows relevant national 2001/82/EC) legislation

Ubropen 600 mg Vetcare Oy VPA10832/002/ 600 mg/syringe Intramammary - QJ51CE09 POM: - Benzylpenicillin Generic - Intramammary intramammary 001 suspension Prescription Only procaine application use suspension for Medicine as (Article 13(1) of lactating cows defined in Directive No relevant national 2001/82/EC) legislation

Ubroseal blue Univet Limited VPA10990/049/ 2.6 g/syringe Intramammary - QG52X POM: - Bismuth Hybrid - Intramammary Dry Cow 2.6 g 001 suspension Prescription Only subnitrate, heavy application use intramammary Medicine as (Article 13(3) of suspension for defined in Directive No cattle relevant national 2001/82/EC) legislation

Ubrostar Red Boehringer VPA10454/001/ 100, 280, 100 Intramammary - QJ51RC25 POM: - Penethamate Generic - Intramammary 100 mg / 280 mg Ingelheim 001 mg/syringe suspension Prescription Only hydriodide application use / 100 mg Vetmedica Medicine as - Benethamine (Article 13(1) of Intramammary GmbH defined in penicillin Directive No Suspension for relevant national - Framycetin 2001/82/EC) cattle legislation sulphate

UDDERgold Ecolab VPA10795/001/ 6.4 Teat dip solution - QG52A LM: Licensed - Lactic acid ZZZ Complete - Topical use Platinum Deutschland 001 milligram(s)/millil Merchant as - Sodium chlorite application Germicidal GmbH itre defined in (stand-alone) - Barrier Teat Dip relevant national Council Directive Solution legislation 81/851/EEC Concentrates (Base and Activator) for Teat Dip Solution For Cattle (Dairy

UISCE-JECT, SP Veterinaria, VPA10790/013/ 100 percent Solvent for - QV07AB POM: - Water for Generic - Intramuscular 100 % v/v, S.A. 001 volume/volume parenteral use Prescription Only injections application use solvent for Medicine as (Article 13(1) of - Intravenous parenteral use defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Ultrapen LA 300 Norbrook VPA22664/045/ 300 Suspension for - QJ01CE09 POM: - Procaine Full application - Intramuscular mg/ml Laboratories 001 milligram(s)/millil injection Prescription Only benzylpenicillin (Article 12(3) of use Suspension for (Ireland) Limited itre Medicine as Directive No - Subcutaneous Injection defined in 2001/82/EC) use relevant national legislation

Unicillin 300 Univet Limited VPA10990/003/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin - Intramuscular mg/ml 001 milligram(s)/millil injection Prescription Only procaine use Suspension for itre Medicine as Injection defined in relevant national legislation

Uniferon 20 % Pharmacosmos VPA10794/001/ 20 percent Solution for - QB03AC LM: Licensed - Iron dextran ZZZ Complete - Intramuscular w/v Solution for A/S 001 weight/volume injection Merchant as application use Injection defined in (stand-alone) - relevant national Council Directive legislation 81/851/EEC

Unisol 100 Vetpharma VPA10516/003/ 100 Solution for use - QJ01MA90 POM: - Enrofloxacin Generic - Oral use mg/ml Oral Animal Health, 001 milligram(s)/millil in drinking water Prescription Only application Solution for use S.L. itre Medicine as (Article 13(1) of in drinking water defined in Directive No for chickens and relevant national 2001/82/EC) turkeys legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 190 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Unisol 100 Vetpharma VPA10516/001/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml solution Animal Health, 001 milligram(s)/millil injection Prescription Only application use for injection for S.L. itre Medicine as (Article 13(1) of - Intravenous cattle and pigs defined in Directive No use relevant national 2001/82/EC) - Subcutaneous legislation use

Unisol 25 mg/ml Vetpharma VPA10516/018/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use oral solution for Animal Health, 001 milligram(s)/millil Prescription Only application calves S.L. itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Unisol 5 mg/ml Vetpharma VPA10516/017/ 5 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use oral solution for Animal Health, 001 milligram(s)/millil Prescription Only application piglets S.L. itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

UNISTRAIN Laboratorios VPA10846/013/ 10(3.5) - 10(5.5) Lyophilisate and - QI09AD03 POM: - Live attenuated Full application - Intradermal use PRRS Hipra S.A. 001 cell culture solvent for Prescription Only prrsv, strain vp- (Article 12(3) of - Intramuscular lyophilisate and infective dose suspension for Medicine as 046 bis Directive No use solvent for 50/dose injection defined in 2001/82/EC) suspension for relevant national injection for pigs legislation

Univet Multidose Univet Limited VPA10990/026/ 15.0, 22.5 Oral suspension - QP52AE51 POM: - Levamisole ZZZ Informed - Oral use Fluke and Worm 001 milligram(s)/millil Prescription Only hydrochloride consent Drench itre Medicine as - Rafoxanide (abridged defined in application) - relevant national Council Directive legislation 81/851/EEC

Unomec 5 mg/ml Chanelle VPA10987/110/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Generic - Topical use Pour-on Solution Pharmaceuticals 001 milligram(s)/millil Prescription Only application for beef and Manufacturing itre Medicine as (Article 13(1) of dairy cattle Limited defined in Directive No relevant national 2001/82/EC) legislation

Unomox 1 mg/ml Chanelle VPA10987/119/ 1 Oral solution - QP54AB52 POM: - Moxidectin Generic - Oral use oral solution for Pharmaceuticals 001 milligram(s)/millil Prescription Only application sheep Manufacturing itre Medicine as (Article 13(1) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Uraw LHV Bonapp HOVR10466/00 Oral solution LM: Licensed - Calcarea - Oral use 6/001 Merchant as carbonica defined in - Euphrasia relevant national officinalis legislation - Thuya - Solidago virgaurea Urilin 40 mg/ml Dechra VPA22622/020/ 40 Syrup - QG04BX91 POM: - Generic - Oral use syrup for dogs Regulatory B.V. 001 milligram(s)/millil Prescription Only Phenylpropanol application itre Medicine as amine (Article 13(1) of defined in hydrochloride Directive No relevant national 2001/82/EC) legislation

Utertab 2000 mg aniMedica VPA10826/024/ 2000 mg/tablet Intrauterine - QG51AA02 POM: - Tetracycline Hybrid - Intrauterine use intrauterine GmbH 001 tablet Prescription Only hydrochloride application tablet for cattle Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 191 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration VALEMAS 50 FATRO S.p.A. VPA10836/005/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular mg/ml solution 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of - Intravenous cattle, sheep, defined in Directive No use goats, pigs, dogs relevant national 2001/82/EC) - Subcutaneous and cats. legislation use

VANGUARD 7. Zoetis Belgium VPA10387/082/ . Lyophilisate and - QI07AI02 POM: - Canine Full application - Subcutaneous S.A. 001 solvent for Prescription Only distemper virus (Article 12(3) of use solution for Medicine as strain N-CDV Directive No injection defined in (live, attenuated) 2001/82/EC) relevant national - Canine legislation 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 icterohaemorrha giae inactivated - Leptospira canicola inactivated

Vanguard CPV. Zoetis Belgium VPA10387/083/ . Solution for - QI07AD01 POM: - Live canine Full application - Subcutaneous S.A. 001 injection Prescription Only parvovirus strain (Article 12(3) of use Medicine as NL-35-D Directive No defined in 2001/82/EC) relevant national legislation

VANGUARD Zoetis Belgium VPA10387/084/ . Solution for - QI07AI05 POM: - Live canine Full application - Subcutaneous CPV-L. S.A. 001 injection Prescription Only parvovirus strain (Article 12(3) of use Medicine as NL-35-D Directive No defined in - Inactivated 2001/82/EC) relevant national leptospira legislation canicola - Inactivated leptospira icterohaemorrha giae Vanguard Lepto- Zoetis Belgium VPA10387/085/ . Solution for - QI07AB01 POM: - Leptospira Full application - Subcutaneous ci S.A. 001 injection Prescription Only icterohaemorrha (Article 12(3) of use Medicine as giae inactivated Directive No defined in - Leptospira 2001/82/EC) relevant national canicola legislation inactivated

Vasotop 0.625 Intervet Ireland VPA10996/138/ 0.625 mg/tablet Tablet - QC09AA05 POM: - Ramipril - Oral use mg tablets Limited 004 Prescription Only Medicine as defined in relevant national legislation

Vasotop 1.25 mg Intervet Ireland VPA10996/138/ 1.25 mg/tablet Tablet - QC09AA05 POM: - Ramipril - Oral use tablets Limited 001 Prescription Only Medicine as defined in relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 192 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Vasotop 10.0 mg Intervet Ireland VPA10996/138/ 10 mg/tablet Tablet - QC09AA05 POM: - Ramipril - Oral use tablets Limited 005 Prescription Only Medicine as defined in relevant national legislation

Vasotop 2.5 mg Intervet Ireland VPA10996/138/ 2.5 mg/tablet Tablet - QC09AA05 POM: - Ramipril - Oral use tablets Limited 002 Prescription Only Medicine as defined in relevant national legislation

Vasotop 5 mg Intervet Ireland VPA10996/138/ 5 mg/tablet Tablet - QC09AA05 POM: - Ramipril - Oral use tablets Limited 003 Prescription Only Medicine as defined in relevant national legislation

Vecoxan 2.5 Intervet Ireland VPA10996/285/ 2.5 Oral suspension - QP51AJ03 POM: - Diclazuril Full application - Oral use mg/ml Oral Limited 001 milligram(s)/millil Prescription Only (Article 12(3) of Suspension for itre Medicine as Directive No lambs and defined in 2001/82/EC) calves relevant national legislation

Veloxa LAVET VPA10482/002/ 50, 150, 50 Chewable tablet - QP52AA51 CAM: - Praziquantel - Oral use Chewable Pharmaceuticals 001 mg/tablet Companion - Pyrantel Tablets for Dogs Ltd Animal Medicine - Febantel as defined in relevant national legislation

Veloxa XL LAVET VPA10482/003/ 175, 175, 525 Chewable tablet - QP52AA51 CAM: - Praziquantel Generic - Oral use Chewable Pharmaceuticals 001 mg/tablet Companion - Pyrantel application Tablets for Dogs Ltd Animal Medicine - Febantel (Article 13(1) of as defined in Directive No relevant national 2001/82/EC) legislation

Ventipulmin Boehringer VPA10454/018/ 16 microgram Granules - QR03CC13 POM: - Clenbuterol Full application - Oral use Granules 16 Ingelheim 001 per gram Prescription Only hydrochloride (Article 12(3) of micrograms/gra Vetmedica Medicine as Directive No m GmbH defined in 2001/82/EC) relevant national legislation

Ventipulmin Boehringer VPA10454/019/ 30 Solution for - QR03CC13 POM: - Clenbuterol Full application - Intravenous Solution for Ingelheim 001 microgram(s)/mil injection Prescription Only hydrochloride (Article 12(3) of use Injection 30 Vetmedica lilitre Medicine as Directive No micrograms/ml GmbH defined in 2001/82/EC) relevant national legislation

Ventipulmin Boehringer VPA10454/020/ 25 Syrup - QR03CC13 POM: - Clenbuterol Full application - Oral use Syrup 25 Ingelheim 001 microgram(s)/mil Prescription Only hydrochloride (Article 12(3) of micrograms/ml Vetmedica lilitre Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

Vermisole 75 Bimeda Animal VPA22033/045/ 75 Solution for - QP52AE01 POM: - Levamisole Well-established - Subcutaneous mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only hydrochloride use application use for Injection itre Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 193 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Vermisole Worm Bimeda Animal VPA22033/046/ 1.5 percent Oral solution - QP52AE01 POM: - Levamisole Well-established - Oral use Drench for Cattle Health Limited 001 weight/volume Prescription Only hydrochloride use application and Sheep Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

Versican Plus Bb Zoetis Belgium VPA10387/097/ . Lyophilisate + - QI07AE01 POM: - Bordetella Full application - Oral use Oral lyophilisate S.A. 001 solvent for Prescription Only bronchiseptica, (Article 12(3) of and solvent for suspension Medicine as live Directive No oral suspension defined in 2001/82/EC) for dogs relevant national legislation

Versican Plus Zoetis Belgium VPA10387/098/ . Lyophilisate and - QI07AF01 POM: - Bordetella Full application - Nasal use BbPi IN nasal S.A. 001 solvent for Prescription Only bronchiseptica, (Article 12(3) of drops, suspension for Medicine as live Directive No lyophilisate and nasal defined in - Canine 2001/82/EC) solvent for administration relevant national parainfluenza suspension for legislation virus, live dogs Versican Plus P Zoetis Belgium VPA10387/087/ . Lyophilisate and - QI07AD01 POM: - Canine Full application - Subcutaneous lyophilisate and S.A. 001 solvent for Prescription Only parvovirus, live (Article 12(3) of use solvent for suspension for Medicine as Directive No suspension for injection defined in 2001/82/EC) injection for dogs relevant national legislation

Versifel Zoetis Belgium VPA10387/088/ . Suspension for - QI06AA01 POM: - Inactivated Full application - Subcutaneous FeLV,suspensio S.A. 001 injection Prescription Only feline leukaemia (Article 12(3) of use n for injection for Medicine as virus(FeLV) Directive No cats defined in subtypes A, B 2001/82/EC) relevant national and C legislation

Versiguard Zoetis Belgium VPA10387/086/ Minimum 2.0 Suspension for - QI07AA02 POM: - Inactivated Full application - Intramuscular Rabies, S.A. 001 international injection Prescription Only rabies virus, (Article 12(3) of use suspension for unit(s) Medicine as strain vnukovo- Directive No - Subcutaneous injection defined in 32 2001/82/EC) use relevant national legislation

Vetbromide 600 Domes Pharma VPA10386/008/ 600 milligram(s) Tablet - QN03AX91 POM: - Potassium Full application - Oral use mg tablets for SC 001 Prescription Only bromide (Article 12(3) of dogs Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Veteglan 0.075 LABORATORIO VPA10665/008/ 0.075 Solution for - QG02AD90 POM: - d-Cloprostenol Generic - Intramuscular mg/ml Solution S CALIER S.A. 001 milligram(s)/millil injection Prescription Only application use for injection for itre Medicine as (Article 13(1) of cows, sows and defined in Directive No mares relevant national 2001/82/EC) legislation

Vetemex 10 CP-Pharma VPA10810/016/ 10 Solution for - QA04AD90 POM: - Maropitant Generic - Intravenous mg/ml solution Handelsgesellsc 001 milligram(s)/millil injection Prescription Only application use for injection for haft mbH itre Medicine as (Article 13(1) of - Subcutaneous dogs and cats defined in Directive No use relevant national 2001/82/EC) legislation

VETERELIN LABORATORIO VPA10665/003/ 0.004 Solution for - QH01CA90 POM: - Buserelin Generic - Intramuscular 0.004 mg/ml S CALIER S.A. 001 milligram(s)/millil injection Prescription Only application use solution for itre Medicine as (Article 13(1) of - Intravenous injection for defined in Directive No use cattle, horses, relevant national 2001/82/EC) - Subcutaneous pigs and rabbits legislation use

Veterinary Medicines Authorised/Transfer Pending Products Page 194 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Vetergesic Ceva Santé VPA10815/028/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Well-established - Intramuscular Multidose, 0.3 Animale 001 milligram(s)/millil injection Practitioner Only use application use mg/ml, solution itre as defined in (Article 13a of - Intravenous for injection for relevant national Directive No use dogs and cats legislation 2001/82/EC)

Vetflurane 1000 Virbac S.A. VPA10988/085/ 1000 Inhalation - QN01AB06 VPO: Veterinary - Isoflurane Generic - Inhalation use mg/g Inhalation 001 milligram(s)/gra vapour, liquid Practitioner Only application vapour, liquid m as defined in (Article 13(1) of relevant national Directive No legislation 2001/82/EC)

Vetimec 6 mg/g ECO Animal VPA22693/014/ 6 Premix for - QP54AA01 POM: - Ivermectin Generic - Oral use Premix for Health Europe 001 milligram(s)/gra medicated Prescription Only application medicated Limited m feeding stuff Medicine as (Article 13(1) of feeding stuff for defined in Directive No pigs relevant national 2001/82/EC) legislation

Vetivex 1 (9 Dechra VPA22622/021/ 9 Solution for - QB05BB01 POM: - Sodium Generic - Intravenous mg/ml) solution Regulatory B.V. 001 milligram(s)/millil infusion Prescription Only chloride application use for infusion for itre Medicine as (Article 13(1) of cattle, horses, defined in Directive No dogs and cats relevant national 2001/82/EC) legislation

Vetivex 11 Dechra VPA22622/022/ 3.2, 6, 0.4, 0.2 Solution for - QB05BB01 POM: - Sodium lactate Generic - Intravenous (Hartmann's) Regulatory B.V. 001 milligram(s)/millil infusion Prescription Only - Sodium application use solution for itre Medicine as chloride (Article 13(1) of infusion for defined in - Potassium Directive No cattle, horses, relevant national chloride 2001/82/EC) dogs and cats legislation - Calcium chloride dihydrate

Vetmedin 0.75 Boehringer VPA10454/022/ 0.75 Solution for - QC01CE90 POM: - Pimobendan Generic - Intravenous mg/ml solution Ingelheim 001 milligram(s)/millil injection Prescription Only application use for injection for Vetmedica itre Medicine as (Article 13(1) of dogs GmbH defined in Directive No relevant national 2001/82/EC) legislation

Vetmedin 1.25 Boehringer VPA10454/023/ 1.25 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use mg chewable Ingelheim 001 Prescription Only application tablets for dogs Vetmedica Medicine as (Article 13(1) of GmbH defined in Directive No relevant national 2001/82/EC) legislation

Vetmedin 10 mg Boehringer VPA10454/023/ 10 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use chewable tablets Ingelheim 004 Prescription Only application for dogs Vetmedica Medicine as (Article 13(3) of GmbH defined in Directive No relevant national 2001/82/EC) legislation

Vetmedin 2.5 mg Boehringer VPA10454/023/ 2.5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use chewable tablets Ingelheim 002 Prescription Only application for dogs Vetmedica Medicine as (Article 13(1) of GmbH defined in Directive No relevant national 2001/82/EC) legislation

Vetmedin 5 mg Boehringer VPA10454/021/ 5 milligram(s) Capsule, hard - QC01CE90 POM: - Pimobendan Full application - Oral use capsules Ingelheim 001 Prescription Only (Article 12(3) of Vetmedica Medicine as Directive No GmbH defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 195 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Vetmedin 5 mg Boehringer VPA10454/023/ 5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use chewable tablets Ingelheim 003 Prescription Only application for dogs Vetmedica Medicine as (Article 13(1) of GmbH defined in Directive No relevant national 2001/82/EC) legislation

Vetmedin Chew Boehringer VPA10454/024/ 1.25 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use 1.25 mg Ingelheim 001 Prescription Only application chewable tablets Vetmedica Medicine as (Article 13(1) of for dogs. GmbH defined in Directive No relevant national 2001/82/EC) legislation

Vetmedin Chew Boehringer VPA10454/024/ 10 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use 10 mg chewable Ingelheim 004 Prescription Only application tablets for dogs Vetmedica Medicine as (Article 13(3) of GmbH defined in Directive No relevant national 2001/82/EC) legislation

Vetmedin Chew Boehringer VPA10454/024/ 2.5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use 2.5 mg chewable Ingelheim 002 Prescription Only application tablets for dogs Vetmedica Medicine as (Article 13(3) of GmbH defined in Directive No relevant national 2001/82/EC) legislation

Vetmedin Chew Boehringer VPA10454/024/ 5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use 5 mg chewable Ingelheim 003 Prescription Only application tablets for dogs Vetmedica Medicine as (Article 13(1) of GmbH defined in Directive No relevant national 2001/82/EC) legislation

Vetmulin 100 Huvepharma NV VPA10782/005/ 100 Premix for - QJ01XQ01 POM: - Tiamulin - Oral use g/kg premix for 002 gram(s)/kilogra medicated Prescription Only hydrogen medicated m(s) feeding stuff Medicine as fumarate feeding stuff for defined in pigs, chickens, relevant national turkeys and legislation rabbits Vetmulin 100 Huvepharma NV VPA10782/010/ 100 Granules - QJ01XQ01 POM: - Tiamulin - Oral use mg/g oral 001 milligram(s)/gra Prescription Only hydrogen granules for pigs m Medicine as fumarate defined in relevant national legislation

VETMULIN 125 Huvepharma NV VPA10782/009/ 125 Solution for use - QJ01XQ01 POM: - Tiamulin Generic - In drinking mg/ml Solution 002 milligram(s)/millil in drinking water Prescription Only hydrogen application water use for use in itre Medicine as fumarate (Article 13(1) of drinking water for defined in Directive No pigs and relevant national 2001/82/EC) chickens legislation

VETMULIN 162 Huvepharma NV VPA10782/008/ 162 Solution for - QJ01XQ01 POM: - Tiamulin - Intramuscular mg/ml Solution 001 milligram(s)/millil injection Prescription Only use for Injection for itre Medicine as pigs defined in relevant national legislation

Vetmulin 20 g/kg Huvepharma NV VPA10782/005/ 20 Premix for - QJ01XQ01 POM: - Tiamulin - Oral use premix for 001 gram(s)/kilogra medicated Prescription Only hydrogen medicated m(s) feeding stuff Medicine as fumarate feeding stuff for defined in pigs, chickens, relevant national turkeys and legislation rabbits

Veterinary Medicines Authorised/Transfer Pending Products Page 196 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Vetmulin 450 Huvepharma NV VPA10782/002/ 450 Granules - QJ01XQ01 POM: - Tiamulin Generic - In drinking mg/g granules 001 milligram(s)/gra Prescription Only hydrogen application water use for use in m Medicine as fumarate (Article 13(1) of - Oral use drinking water for defined in Directive No pigs, chickens relevant national 2001/82/EC) and turkeys legislation

Vetofol 10 mg/ml Norbrook VPA22664/109/ 10 Emulsion for - QN01AX10 VPO: Veterinary - Propofol Generic - Intravenous Emulsion for Laboratories 001 milligram(s)/millil injection Practitioner Only application use Injection for Cats (Ireland) Limited itre as defined in (Article 13(1) of and Dogs relevant national Directive No legislation 2001/82/EC)

Vetoryl 10 mg Dechra VPA22622/023/ 10 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Full application - Oral use hard capsules for Regulatory B.V. 001 capsule Prescription Only (Article 12(3) of dogs Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Vetoryl 120 mg Dechra VPA22622/023/ 120 Milligrams Capsule, hard - QH02CA01 POM: - Trilostane Full application - Oral use hard capsules Regulatory B.V. 004 per capsule Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Vetoryl 30 mg Dechra VPA22622/023/ 30 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Full application - Oral use hard capsules Regulatory B.V. 002 capsule Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Vetoryl 5 mg Dechra VPA22622/023/ 5 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Full application - Oral use hard capsules for Regulatory B.V. 005 capsule Prescription Only (Article 12(3) of dogs Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Vetoryl 60 mg Dechra VPA22622/023/ 60 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Full application - Oral use hard capsules Regulatory B.V. 003 capsule Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Vetrimoxin Ceva Santé VPA10815/049/ 50 Premix for - QJ01CA04 POM: - Amoxicillin Generic - Oral use 50mg/g Premix Animale 001 milligram(s)/gra medicated Prescription Only application for medicated m feeding stuff Medicine as (Article 13(1) of feeding stuff for defined in Directive No pigs relevant national 2001/82/EC) legislation

Vetrisul Powder Eurovet Animal VPA10989/031/ 40 Powder for oral - QJ01EW10 POM: - Trimethoprim - Oral use Health B.V. 001 milligram(s)/gra administration Prescription Only - Sulfadiazine m Medicine as defined in relevant national legislation

Vidalta 10 mg Intervet Ireland VPA10996/263/ 10 mg/tablet Tablet - QH03BB01 POM: - Carbimazole Full application - Oral use prolonged- Limited 001 Prescription Only (Article 12(3) of release tablets Medicine as Directive No for cats defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 197 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Vidalta 15 mg Intervet Ireland VPA10996/263/ 15 mg/tablet Tablet - QH03BB01 POM: - Carbimazole Full application - Oral use prolonged- Limited 002 Prescription Only (Article 12(3) of release tablets Medicine as Directive No for cats defined in 2001/82/EC) relevant national legislation

Vigophos 100 LIVISTO Int'l, VPA10425/007/ 100, 0.05 Solution for - QA12CX91 POM: - Butafosfan Generic - Intravenous mg / ml + 0.05 S.L. 001 milligram(s)/millil injection Prescription Only - application use mg / ml solution itre Medicine as Cyanocobalamin (Article 13(1) of for injection for defined in Directive No cattle relevant national 2001/82/EC) legislation

VIMCO emulsion Laboratorios VPA10846/016/ . Emulsion for - QI03AB POM: - Staphylococcus Full application - Intramuscular for injection for Hipra S.A. 001 injection Prescription Only aureus SP140 (Article 12(3) of use ewes and female Medicine as CP8 strain, Directive No goats defined in inactivated, 2001/82/EC) relevant national expressing legislation biofilm components

VIRBAGEST 4 Virbac S.A. VPA10988/086/ 4 Oral solution - QG03DX90 POM: - Altrenogest Generic - Oral use mg/ml oral 001 milligram(s)/millil Prescription Only application solution for pigs itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Virbamec Virbac S.A. VPA10988/105/ 10 Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous Injectable 001 milligram(s)/millil injection Prescription Only application use Solution 10 itre Medicine as (Article 13(1) of mg/ml defined in Directive No relevant national 2001/82/EC) legislation

Virbamec Virbac S.A. VPA10988/107/ 10 Solution for - QP54AA01 POM: - Ivermectin Generic - Subcutaneous Injectable 001 milligram(s)/millil injection Prescription Only application use Solution for itre Medicine as (Article 13(1) of Cattle, Swine defined in Directive No and Sheep 10 relevant national 2001/82/EC) mg/ml legislation

VIRBAMEC Virbac S.A. VPA10988/106/ 5 Pour-on solution - QP54AA01 POM: - Ivermectin - Topical use Pour-On solution 001 milligram(s)/millil Prescription Only for cattle 5 mg/m itre Medicine as defined in relevant national legislation

Virbamec Super Virbac S.A. VPA10988/108/ 10, 100 Solution for - QP54AA51 POM: - Ivermectin Full application - Subcutaneous Solution For 001 milligram(s)/millil injection Prescription Only - Clorsulon (Article 12(3) of use Injection itre Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Vitamin B1 100 Bimeda Animal VPA22033/047/ 100 Solution for - QA11DA01 POM: - Thiamine - Intramuscular mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only hydrochloride use for Injection itre Medicine as - Intravenous defined in use relevant national legislation

Vitamin K1 10 Bimeda Animal VPA22033/048/ 10 Solution for - QB02 POM: - - Intramuscular mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only Phytomenadione use for Injection itre Medicine as (Vitamin K1) - Intravenous defined in use relevant national - Subcutaneous legislation use

Veterinary Medicines Authorised/Transfer Pending Products Page 198 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration VITBPLEX Chem-Pharm VPA10823/018/ .
Solution for - QA11E LM: Licensed - Thiamine Informed - Intramuscular Solution for 001 injection Merchant as hydrochloride consent use Injection defined in - Riboflavin application - Subcutaneous relevant national sodium (Article 13c of use legislation phosphate Directive No - Pyridoxine 2001/82/EC) hydrochloride - Nicotinamide - Ascorbic acid Vitesel Norbrook VPA22664/034/ 68, 1.5 Suspension for - QA11J POM (E): - all-rac-a- - Intramuscular Suspension for Laboratories 001 milligram(s)/millil injection Prescription Only Tocopheryl use Injection (Ireland) Limited itre Exempt as acetate - Subcutaneous defined in - Potassium use relevant national selenate legislation

Vitofyllin 100 mg WDT - VPA10660/002/ 100 mg/tablet Film-coated - QC04AD90 POM: - Propentofylline Generic - Oral use film-coated Wirtschaftsgeno 002 tablet Prescription Only application tablets for dogs ssenschaft Medicine as (Article 13(1) of deutscher defined in Directive No Tierarzte eG relevant national 2001/82/EC) legislation

Vitofyllin 50 mg WDT - VPA10660/002/ 50 mg/tablet Film-coated - QC04AD90 POM: - Propentofylline Generic - Oral use film-coated Wirtschaftsgeno 001 tablet Prescription Only application tablets for dogs ssenschaft Medicine as (Article 13(1) of deutscher defined in Directive No Tierarzte eG relevant national 2001/82/EC) legislation

Vivitonin 100 mg Intervet Ireland VPA10996/127/ 100 mg/tablet Tablet - QC04AD90 POM: - Propentofylline Full application - Oral use film-coated Limited 002 Prescription Only (Article 12(3) of tablets Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Vivitonin 50 mg Intervet Ireland VPA10996/127/ 50 mg/tablet Film-coated - QC04AD90 POM: - Propentofylline Full application - Oral use film-coated Limited 001 tablet Prescription Only (Article 12(3) of tablets Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Voxical Plus Chanelle VPA10987/090/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use Tablets for dogs Pharmaceuticals 001 mg/tablet Companion - Febantel application Manufacturing Animal Medicine - Pyrantel (Article 13(3) of Limited as defined in embonate Directive No relevant national 2001/82/EC) legislation

Voxical Plus XL Chanelle VPA10987/090/ 175,504,525 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use Tablets For Dog Pharmaceuticals 002 mg/tablet Companion - Febantel application Manufacturing Animal Medicine - Pyrantel (Article 13(3) of Limited as defined in embonate Directive No relevant national 2001/82/EC) legislation

Vulketan 2.5 AUDEVARD VPA10481/003/ 2.5 Gel - QD03AX90 POM: - Ketanserin Generic - Cutaneous use mg/g gel for 001 milligram(s)/gra Prescription Only tartrate application horses m Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Wellplus Divasa-Farmavic VPA10505/003/ 150, 144, 50 Tablet - QP52AA30 CAM: - Febantel Generic - Oral use Flavoured tablets S.A. 001 mg/tablet Companion - Pyrantel application for Dogs Animal Medicine embonate (Article 13(1) of as defined in - Praziquantel Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 199 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Winter Dip Hygeia VPA10203/001/ 10 percent Concentrate for - QP53AF03 POM: - Diazinon Well-established - Topical use Concentrate for Chemicals Ltd 001 weight/volume dip emulsion Prescription Only (dimpylate) use application dip emulsion Medicine as (Article 13a of defined in Directive No relevant national 2001/82/EC) legislation

WORMALL Coyle Veterinary VPA10889/002/ 2.265 percent Oral suspension - QP52AC02 POM: - Oxfendazole Informed - Oral use 2.265%w/v Oral Products Ltd. 001 weight/volume Prescription Only consent Suspension Medicine as application defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Wormaway Plus Chanelle VPA10987/089/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use Tablets for dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application Manufacturing Animal Medicine embonate (Article 13(3) of Limited as defined in - Febantel Directive No relevant national 2001/82/EC) legislation

Wormaway Plus Chanelle VPA10987/089/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use XL Tablets For Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application Dogs Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of Limited as defined in - Febantel Directive No relevant national 2001/82/EC) legislation

Xylapan 20 Vetoquinol VPA10983/061/ 20 Solution for - QN05CM92 VPO: Veterinary - Xylazine ZZZ Informed - Intramuscular mg/ml Solution Ireland Limited 001 milligram(s)/millil injection Practitioner Only Hydrochloride consent use for Injection itre as defined in (abridged - Intravenous relevant national application) - use legislation Council Directive - Subcutaneous 81/851/EEC use

Young's Vector Elanco GmbH VPA22020/027/ 12.5 Pour-on solution - QP53AC POM: - Cypermethrin Full application - Topical use 12.5 mg/ml Pour- 001 milligram(s)/millil Prescription Only tech. (cis: trans / (Article 12(3) of on Solution itre Medicine as 80:20) Directive No defined in 2001/82/EC) relevant national legislation

Zanil Fluke Intervet Ireland VPA10996/262/ 3.4 percent Oral suspension - QP52A POM: - Oxyclozanide - Oral use Drench Limited 001 weight/volume Prescription Only Medicine as defined in relevant national legislation

ZANTEL Chanelle VPA10987/060/ 50/500 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel - Oral use Pharmaceuticals 001 Companion - Fenbendazole Manufacturing Animal Medicine Limited as defined in relevant national legislation

Zantel Cat and Chanelle VPA10987/052/ 50/500 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel - Oral use Dog Tablets Pharmaceuticals 001 - QP52AC13 Companion - Fenbendazole Manufacturing Animal Medicine Limited as defined in relevant national legislation

Zelys 1.25 mg Ceva Santé VPA10815/046/ 1.25 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use chewable tablets Animale 001 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 200 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Zelys 10 mg Ceva Santé VPA10815/046/ 10 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use chewable tablets Animale 003 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Zelys 5 mg Ceva Santé VPA10815/046/ 5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use chewable tablets Animale 002 Prescription Only application for dogs Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Zerofen 10% Chanelle VPA10987/017/ 10 percent Oral suspension - QP52AC13 POM: - Fenbendazole - Oral use Oral Suspension Pharmaceuticals 001 weight/volume Prescription Only Manufacturing Medicine as Limited defined in relevant national legislation

Zerofen 2.5% Chanelle VPA10987/017/ 2.5 percent Oral suspension - QP52AC13 POM: - Fenbendazole Informed - Oral use Oral Suspension Pharmaceuticals 002 weight/volume Prescription Only consent Manufacturing Medicine as application Limited defined in (Article 13c of relevant national Directive No legislation 2001/82/EC)

Zerofen 22 % Chanelle VPA10987/140/ 22 percent Granules - QP52AC13 CAM: - Fenbendazole - Oral use Granules Pharmaceuticals 001 weight/weight Companion Manufacturing Animal Medicine Limited as defined in relevant national legislation

Zerofen 4 % Chanelle VPA10987/143/ 4 percent Premix for - QP52AC13 POM: - Fenbendazole - Oral use Premix for Pharmaceuticals 001 weight/weight medicated Prescription Only medicated Manufacturing feeding stuff Medicine as feeding stuff Limited defined in relevant national legislation

Zeromast 600 Bimeda Animal VPA22033/033/ 600 mg/syringe Intramammary - QJ01C POM: - Cloxacillin ZZZ Informed - Intramammary mg/syringe Health Limited 001 suspension Prescription Only benzathine consent use Intramammary Medicine as (abridged Suspension defined in application) - relevant national Council Directive legislation 81/851/EEC

Zeromectin 5 Chanelle VPA10987/109/ 5 Pour-on solution - QP54AA04 POM: - Eprinomectin Generic, hybrid - Topical use mg/ml Pour-on Pharmaceuticals 001 milligram(s)/millil Prescription Only or similar Solution for beef Manufacturing itre Medicine as biological and dairy cattle Limited defined in application relevant national (Article 13 of legislation Directive No 2001/82/EC) Zeronil 134 mg Chanelle VPA10987/093/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 002 Prescription Only application for medium dogs Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Zeronil 268 mg Chanelle VPA10987/093/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 003 Prescription Only application for large dogs Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 201 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Zeronil 402 mg Chanelle VPA10987/093/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 004 Prescription Only application for extra large Manufacturing Medicine as (Article 13(3) of dogs Limited defined in Directive No relevant national 2001/82/EC) legislation

Zeronil 50 mg Chanelle VPA10987/094/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 001 Prescription Only application for cats Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Zeronil 67 mg Chanelle VPA10987/093/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use Spot-on Solution Pharmaceuticals 001 Prescription Only application for small dogs Manufacturing Medicine as (Article 13(3) of Limited defined in Directive No relevant national 2001/82/EC) legislation

Zeronil Combo Chanelle VPA10987/126/ 134, 120.6 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 134 mg/120.6 Pharmaceuticals 002 mg/pipette Prescription Only - (S)-methoprene application mg Spot-on Manufacturing Medicine as (Article 13(3) of Solution for Limited defined in Directive No Medium Dogs relevant national 2001/82/EC) legislation

Zeronil Combo Chanelle VPA10987/126/ 268, 241.2 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 268 mg/241.2 Pharmaceuticals 003 mg/pipette Prescription Only - (S)-methoprene application mg Spot-on Manufacturing Medicine as (Article 13(3) of Solution for Limited defined in Directive No Large Dogs. relevant national 2001/82/EC) legislation

Zeronil Combo Chanelle VPA10987/126/ 402, 361.8 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 402 mg/361.8 Pharmaceuticals 004 mg/pipette Prescription Only - (S)-methoprene application mg Spot-on Manufacturing Medicine as (Article 13(3) of Solution for Extra Limited defined in Directive No Large Dogs. relevant national 2001/82/EC) legislation

Zeronil Combo Chanelle VPA10987/125/ 50, 60 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 50 mg/60 mg Pharmaceuticals 001 mg/pipette Prescription Only - (S)-methoprene application Spot-on Solution Manufacturing Medicine as (Article 13(3) of for Cats and Limited defined in Directive No Ferrets relevant national 2001/82/EC) legislation

Zeronil Combo Chanelle VPA10987/126/ 67, 60.3 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use 67 mg/60.3 mg Pharmaceuticals 001 mg/pipette Prescription Only - (S)-methoprene application Spot-on Solution Manufacturing Medicine as (Article 13(3) of for Small Dogs Limited defined in Directive No relevant national 2001/82/EC) legislation

ZincoTec Zinc Provimi Ltd VPA10446/001/ 100 percent Premix for - QA07XA91 POM: - Zinc oxide Full application - Oral use Oxide 100% 001 medicated Prescription Only (Article 12(3) of Premix for feeding stuff Medicine as Directive No medicated defined in 2001/82/EC) Feeding Stuff relevant national legislation

Zitac vet 100 mg Intervet Ireland VPA10996/202/ 100 mg/tablet Tablet - QA02BA01 POM: - Cimetidine Full application - Oral use tablets for dogs Limited 002 Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 202 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Zitac vet 200 mg Intervet Ireland VPA10996/202/ 200 mg/tablet Tablet - QA02BA01 POM: - Cimetidine Full application - Oral use tablets for dogs Limited 003 Prescription Only (Article 12(3) of Medicine as Directive No defined in 2001/82/EC) relevant national legislation

Z-Itch Floris Holding VPA22969/001/ 40 Pour-on solution - QP53AC04 POM: - Permethrin Generic - Cutaneous use BV 001 milligram(s)/millil Prescription Only (80:20) technical application itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Zodon 150 mg Ceva Santé VPA10815/040/ 150 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Generic - Oral use chewable tablets Animale 002 Prescription Only application for dogs. Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Zodon 25 mg/ml Ceva Santé VPA10815/038/ 25 Oral solution - QJ01FF01 POM: - Clindamycin Generic - Oral use oral solution for Animale 001 milligram(s)/millil Prescription Only application cats and dogs itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Zodon 264 mg Ceva Santé VPA10815/040/ 264 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Hybrid - Oral use chewable tablets Animale 003 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

Zodon 88 mg Ceva Santé VPA10815/040/ 88 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Hybrid - Oral use chewable tablets Animale 001 Prescription Only application for dogs Medicine as (Article 13(3) of defined in Directive No relevant national 2001/82/EC) legislation

ZOLETIL 100 Virbac S.A. VPA10988/099/ 100 Lyophilisate and - QN01AX99 VPO: Veterinary - Tiletamine Generic - Intramuscular (50 mg/ml + 50 002 milligram(s)/millil solvent for Practitioner Only - Zolazepam application use mg/ml) itre solution for as defined in (Article 13(1) of - Intravenous lyophilisate and injection relevant national Directive No use solvent for legislation 2001/82/EC) solution for injection for dogs and cats ZOLETIL 50 (25 Virbac S.A. VPA10988/099/ 50 Lyophilisate and - QN01AX99 VPO: Veterinary - Tiletamine Generic - Intramuscular mg/ml + 25 001 milligram(s)/millil solvent for Practitioner Only - Zolazepam application use mg/ml) itre solution for as defined in (Article 13(1) of - Intravenous lyophilisate and injection relevant national Directive No use solvent for legislation 2001/82/EC) solution for injection for dogs and cats ZORABEL 50 Vetpharma VPA10516/024/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Hybrid - Oral use mg/ml Oral Animal Health, 001 milligram(s)/millil Prescription Only application Suspension for S.L. itre Medicine as (Article 13(3) of pigs defined in Directive No relevant national 2001/82/EC) legislation

Zuritol 25 mg/ml LABORATORIO VPA10665/004/ 25 Oral solution - QP51AJ01 POM: - Toltrazuril Generic - Oral use solution for use S CALIER S.A. 001 milligram(s)/millil Prescription Only application in drinking water itre Medicine as (Article 13(1) of for chickens defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 203 of 204 Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of Holder Number Ingredients Administration Zuritol 50 mg/ml LABORATORIO VPA10665/007/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use oral suspension S CALIER S.A. 001 milligram(s)/millil Prescription Only application for pigs. itre Medicine as (Article 13(1) of defined in Directive No relevant national 2001/82/EC) legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 204 of 204