EN Official Journal of the European Union C 401/9

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2012 to 30 November 2012

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2012/C 401/03

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 19.11.2012 Glimepirida Parke-Davis and associated names See Annex I See Annex I 21.11.2012 19.11.2012 Flukicides - Art 35 (amend) See Annex II See Annex II 23.11.2012





— Suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 30.11.2012 Leflunomide actavis Art 31 Suspension See Annex III See Annex III 4.12.2012 30.11.2012 Leflunomide Apotex Art 31 suspension See Annex IV See Annex IV 4.12.2012

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES Member State EU/EEA Applicant Name Strength Pharmaceutical form Route of administration Cyprus Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepiride Pfizer 2 mg Tablet Oral use Cyprus Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepiride Pfizer 3 mg Tablet Oral use Cyprus Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepiride Pfizer 4 mg Tablet Oral use France Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal GLIMEPIRIDE PFIZER 2 mg, comprimé 2 mg Tablet Oral use France Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal GLIMEPIRIDE PFIZER 3 mg, comprimé 3 mg Tablet Oral use France Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal GLIMEPIRIDE PFIZER 4 mg, comprimé 4 mg Tablet Oral use Germany Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepirid Pfizer 2 mg Tabletten 2 mg Tablet Oral use Germany Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepirid Pfizer 3 mg Tabletten 3 mg Tablet Oral use Germany Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepirid Pfizer 4 mg Tabletten 4 mg Tablet Oral use Italy Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepiride Pfizer 2 mg Tablet Oral use Italy Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepiride Pfizer 3 mg Tablet Oral use Italy Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepiride Pfizer 4 mg Tablet Oral use Portugal Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepirida Parke-Davis 2 mg Tablet Oral use Portugal Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepirida Parke-Davis 3 mg Tablet Oral use Portugal Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepirida Parke-Davis 4 mg Tablet Oral use Sweden Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepirid Pfizer 2 mg Tablet Oral use Sweden Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepirid Pfizer 3 mg Tablet Oral use Sweden Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepirid Pfizer 4 mg Tablet Oral use United Kingdom Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepiride tablets, 2 mg 2 mg Tablet Oral use United Kingdom Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepiride tablets, 3 mg 3 mg Tablet Oral use United Kingdom Parke-Davis Produtos Farmacêuticos Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Glimepiride tablets, 4 mg 4 mg Tablet Oral use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Applicant/Marketing Authorisation Holder Name INN Strength Pharmaceutical form Route of administration Animal species Austria Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Tribex 10 % - orale Suspension für Rinder Triclabendazole 100 mg/ml Oral suspension oral Cattle Austria Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver 50 mg/ml Ijektionslösung für Rinder Closantel 50 mg/ml Solution for injection subcutaneous Cattle Austria Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver Combi 50 und 75 mg/ml Suspension zum Einggeben für Schafe und Lämmer Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep, lambs Austria Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Injektionslösung für Schafe Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Sheep Austria Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Pour on solution for cattle Closantel Ivermectin Information not available Information not available Information not available Information not available Austria Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Injektionslösung für Rinder Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle Austria Novartis Animal Health GmbH Biochemiestr. 10 A-6250 Kundl AUSTRIA Endex 19,5 % - wässrige Suspension für Rinder Triclabendazole Levamisole 120 mg/ml 75 mg/ml Oral suspension oral Cattle Austria Pfizer Corporation Austria GmbH Floridsdorfer Hauptstrasse 1 A-1210 Wien AUSTRIA Cydectin TriclaMox Triclabendazole Moxidectin 50mg/ml 1mg/ml Oral solution oral Sheep Belgium Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Animec Super Solution for Injection for Cattle Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Belgium Chanelle Pharmaceuticals Manufacturing Ltd. IDA Business & Technology Park Loughrea, Co. Galway IRELAND Triclaben 10 % Triclabendazole 100 mg/ml Oral suspension oral Cattle Belgium Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Bimectin Plus 10/100 mg/ml Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Belgium Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver 5 % Closantel 50 mg/ml Solution for injection subcutaneous Cattle Belgium Merial Belgium S.A. Boulevard Sylvain Dupuis 243 B-1070 Bruxelles BELGIUM Dovenix Nitroxinil 250 mg/ml Solution for injection subcutaneous Cattle, Sheep Belgium Merial Belgium S.A. Boulevard Sylvain Dupuis 243 B-1070 Bruxelles BELGIUM Ivomec F Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Belgium Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Solution for Injection for Cattle Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle Belgium Novartis Consumer Health B.V. Claudius Prinsenlaan 142 4818 CP Breda THE NETHERLANDS Endex 19,5 Triclabendazole Levamisole 12 g/100 ml 7,5 g/100 ml Oral suspension oral Cattle Belgium Virbac de Portugal Laboratórios LDA Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2 2080-104 Almeirim PORTUGAL Virbamec F Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Cyprus Vetagrica Ltd 3 Othelou str. 2540 Dali Industrial Estate P.O. Box 17020 Nicosia CYPRUS Ivomec Super injectable solution Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Czech Republic Chanelle Pharmaceuticals Manufacturing Ltd. IDA Business & Technology Park Loughrea, Co. Galway IRELAND Triclaben 100 mg/ml perorální suspenze pro skot Triclabendazole 100 mg/ml Oral suspension oral Cattle Czech Republic Merial S.A.S. 29 Avenue Tony Garnier 69007 Lyon FRANCE Ivomec Super solution for injection Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Czech Republic Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin solution for injection for cattle Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle Czech Republic Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin injekční roztok pro ovce Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Sheep Czech Republic Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin 5 mg/ml + 200 mg/ml Pour on solution for cattle Closantel Ivermectin 200 mg/ml 5 mg/ml Pour-on pour-on use Cattle Denmark Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Bimectin Plus Clorsulon Ivermectin 10 mg/ml 1 mg/ml Solution for injection subcutaneous Cattle Denmark Pfizer Oy Animal Health Tietokuja 4 00330 Helsinki FINLAND Cydectin TriclaMox Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral solution oral Sheep Denmark Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Pour-On Closantel Ivermectin 20 mg/ml 0,5 mg/ml Pour-on Information not available Cattle Denmark Pfizer Oy Animal Health Tietokuja 4 00330 Helsinki FINLAND Cydectin TriclaMox Triclabendazol Moxidectin 200 mg/ml 5 mg/ml Oral solution Information not available Cattle Finland Pfizer Oy Animal Health Tietokuja 4 00330 Helsinki FINLAND Cydectin Triclamox Triclabendazole Moxidectin 5 mg/ml 200 mg/ml Pour-on pour-on Cattle France Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Fascicur 5 % Triclabendazole 50 mg/ml Oral suspension oral Sheep France Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Fascicur 10 % Triclabendazole 100 mg/ml Oral suspension oral Cattle France Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Cevamec D Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle France Janssen-Cilag 1 Rue Camille Desmoulins TSA 91003 92787 Issy Les Moulineaux Cedex 9 FRANCE Flukiver Closantel 50 mg/ml Solution for injection subcutaneous Cattle, Sheep France Janssen-Cilag 1 Rue Camille Desmoulins TSA 91003 92787 Issy Les Moulineaux Cedex 9 FRANCE Seponver Closantel 50 mg/ml Oral suspension oral Cattle, Sheep France Janssen-Cilag 1 Rue Camille Desmoulins TSA 91003 92787 Issy Les Moulineaux Cedex 9 FRANCE Supaverm Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep France Janssen-Cilag 1 Rue Camille Desmoulins TSA 91003 92787 Issy Les Moulineaux Cedex 9 FRANCE Douvigard Closantel 50 mg/ml Solution for injection subcutaneous Cattle, Sheep France Merial S.A.S. 29 Avenue Tony Garnier 69007 Lyon FRANCE DOVENIX Nitroxinil 250 mg/ml Solution for injection subcutaneous Cattle, Sheep France Merial S.A.S. 29 Avenue Tony Garnier 69007 Lyon FRANCE Ivomec D Clorsulon Ivermectin Information not available Solution for injection subcutaneous Information not available France Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Duotech Closantel Oxfendazole 50 mg/ml 25 mg/ml Oral suspension oral Sheep France Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectine Solution Injectable Pour Cattles Closantel Ivermectine 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle France Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectine Solution Injectable Pour Ovines Closantel Ivermectine 125 mg/ml 5 mg/ml Solution for injection subcutaneous Sheep France Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Vermax D Closantel Ivermectine 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle France Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Norofas Pour on Closantel Ivermectine 200 mg/ml 5 mg/ml Pour-on pour-on Cattle France Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE Fascinex 5 % Triclabendazole 50 mg/ml Oral suspension oral Sheep, Goat France Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE Fascinex 10 % Triclabendazole 100 mg/ml Oral suspension oral Cattle France Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE Fascinex Premelange Triclabendazole 200 mg/ml Premix oral Cattle France Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE Parsifal Bovins Triclabendazole Levamisole 120 mg/ml 63,5 mg/ml Oral suspension oral Cattle France Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE Parsifal Ovins Triclabendazole Levamisole 50 mg/ml 32 mg/ml Oral suspension oral Sheep France Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE Triclanil 5 % Triclabendazole 50 mg/ml Oral suspension oral Sheep France Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE Triclanil 10 % Triclabendazole 100 mg/ml Oral suspension oral Cattle France Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE Fascinex 100 Triclabendazole 100 mg/ml Oral suspension oral Sheep France Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE Fascinex 240 Triclabendazole 240 mg/ml Oral suspension oral Cattle France Pfizer Holding France 23/25 Avenue du Docteur Lannelongue 75014 Paris FRANCE Cydectine Triclamox 1 mg/ml + 50 mg/ml Solution Buvable Pour Ovins Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral solution oral Sheep France Pfizer Holding France 23/25 Avenue du Docteur Lannelongue 75014 Paris FRANCE Cydectine Triclamox 5 mg/ml + 200 mg/ml Solution pour Pour-on pour Bovins Triclabendazole Moxidectin 200 mg/ml 5 mg/ml Pour-on pour-on Cattle France Virbac de Portugal Laboratorios LDA Rua do Centro Empresarial Ed. 13, Quinta da Beloura 2710-693 Sintra PORTUGAL Virbamec D Solution Injectable Clorsulon Ivermectine 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Germany AniMedica GmbH Im Südfeld 9 D-48308 Senden-Bösensell GERMANY Endofluke 100 mg/ml orale Suspension Triclabendazole 100 mg/ml Oral suspension oral Cattle, sheep Germany AniMedica GmbH Im Südfeld 9 D-48308 Senden-Bösensell GERMANY Endofluke Triclabendazole 100 mg/ml Oral suspension oral Cattle Germany Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd. Broomhill Road TALLAGHT DUBLIN 24 IRELAND Bimectin Fluke Clorsulon Ivermectin 10 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Germany Chanelle Pharmaceuticals Manufacturing Ltd. IDA Business & Technology Park Loughrea, Co. Galway IRELAND Triclaben 10 % Triclabendazole 100 mg/ml Oral suspension oral Cattle Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss GERMANY Flukiver Closantel 50 mg/ml Oral suspension oral Cattle, sheep Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss GERMANY Flukiver Combi Closantel Mebendazole 50 mg/ml 75 mg/ml Oral solution oral Sheep, lambs Germany Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Pour-On Closantel Ivermectin 200 mg/ml 5 mg/ml Pour-on pour-on Cattle Germany Novartis Tiergesundheit GmbH Zielstattstr. 40 D-81379 München GERMANY Fasinex 10 % Triclabendazole 100 mg/ml Oral suspension oral Cattle, sheep Germany Pfizer GmbH Linkstr. 10 D-10785 Berlin GERMANY Cydectin Triclamox 5 mg/ml Triclabendazole Moxidectin 200 mg/ml 5 mg/ml Pour-on pour-on Cattle Germany Pfizer GmbH Linkstr. 10 D-10785 Berlin GERMANY Cydectin TriclaMox 1 mg/ml + 50 mg/ml Lösung zum Eingeben für Schafe Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral solution oral Sheep Greece Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver Combi Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep, Lambs Greece New Vet 15 Fleming Street Maroussi 15123 GREECE Zivet Closantel Oxfendazole 5 mg/ml 2,5 mg/ml Oral suspension oral Sheep Greece Pfizer Hellas AE Mesogeion 243 N.Psichiko 15451 GREECE Cydectin Triclamox Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral solution oral Sheep Greece Provet Aspropyrgos 19300, Attik GREECE Rafoxanide/Provet Rafoxanide 300 mg/tab Tablets oral Sheep Hungary Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver 5 % injekció A.U.V. Closantel 50 mg/ml Solution for injection subcutaneous Cattle, Sheep Hungary Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver Combi belsőleges szuszpenzió A.U.V. Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep Hungary Merial S.A.S. 29 Avenue Tony Garnier 69007 Lyon FRANCE Ivomec Super injekció A.U.V. Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Iceland Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver Combi vet Closantel 50/75 mg/ml Oral solution oral Sheep, Lambs Ireland Biochem Ltd Pulleen Kanturk Co. Cork IRELAND Levafluke Rafoxanide Levamisole 22,5 mg/ml 15 mg/ml Oral suspension oral Cattle, Sheep Ireland C & H Generics Ltd c/o Michael McEvoy Seville House New Dock Street Galway IRELAND Chanectin Super Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Ireland Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Chan Broad Spec Rafoxanide Levamisole 22,5 mg/ml 15 mg/ml Oral suspension oral Cattle, Sheep Ireland Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Rafazole Oral Suspension Rafoxanide Levamisole 30 mg/ml 30 mg/ml Oral suspension oral Cattle, Sheep Ireland Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Ridafluke 3 % Rafoxanide 30 mg/ml Oral suspension oral Cattle Sheep Ireland Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Animec Super Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Ireland Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Levatum Super Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Ireland Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Tribex 10 % for cattle Triclabendazole 100 mg/ml Oral suspension oral Cattle Ireland Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Tribex 5 % for Sheep Triclabendazole 50 mg/ml Oral suspension oral Sheep Ireland Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Triclaben 5 % for Sheep Triclabendazole 50 mg/ml Oral suspension oral Sheep Ireland Chanelle Pharmaceuticals Manufacturing Limited Dublin Road Loughrea Co. Galway IRELAND Triclaben 10 % for cattle Triclabendazole 100 mg/ml Oral suspension oral Cattle Ireland Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Endofluke 10 Triclabendazole 100 mg/ml Oral suspension oral Cattle, Sheep Ireland Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Fasifree 10 % Triclabendazole 100 mg/ml Oral suspension oral Cattle, Sheep Ireland Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Bimectin Plus Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Ireland Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Mectaject Plus Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Ireland Interchem Ireland Ltd Road M Unit 12 Tougher Business Park Newhall Naas Co. Kildare IRELAND Orafluke 10 % Rafoxanide Fenbendazole 100 mg/ml 100 mg/ml Oral suspension oral Cattle Ireland Interchem Ireland Ltd Road M Unit 12 Tougher Business Park Newhall Naas Co. Kildare IRELAND Orafluke 5 % Rafoxanide Fenbendazole 50 mg/ml 50 mg/ml Oral suspension oral Cattle, Sheep Ireland Intervet Ireland Ltd Magna Drive Magne Business Park Citywest Road Dublin 24 Ireland Panafluke Oral Suspension Rafoxanide Fenbendazole 45 mg/ml 30 mg/ml Oral suspension oral Cattle, Sheep Ireland Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UNITED KINGDOM Flukiver 5 Injection Closantel 50 mg/ml Solution for injection subcutaneous Cattle, Sheep Ireland Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UNITED KINGDOM Flukiver Combi Oral Suspension Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep Ireland Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UNITED KINGDOM Supaverm Oral Suspension Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep Ireland Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UNITED KINGDOM Flukiver Bovis Closantel 50 mg/ml Solution for injection subcutaneous Cattle Ireland Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UNITED KINGDOM Flukiver 5 % w/v Oral Suspension Closantel 50 mg/ml Oral suspension oral Sheep Ireland Merial Animal Health Limited Sandringham House Sandringham Avenue, Harlow Business Park, Harlow CM19 5TG Essex UNITED KINGDOM Ivomec super Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Ireland Merial Animal Health Limited Sandringham House Sandringham Avenue, Harlow Business Park, Harlow CM19 5TG Essex UNITED KINGDOM Trodax 34 % Nitroxinil 340 mg/ml Solution for injection subcutaneous Cattle, Sheep Ireland Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Pour on Closantel lvermectin 200 mg/ml 5 mg/ml Pour-on pour-on Cattle Ireland Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Closantel lvermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle Ireland Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closiver for cattle Closantel lvermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle Ireland Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin for sheep Closantel lvermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Sheep Ireland Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closiver for sheep Closantel lvermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Sheep Ireland Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Combifluke Oral Suspension for Sheep Closantel Oxfendazole 50 mg/ml 25 mg/ml Oral suspension oral Sheep Ireland Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Parafend Plus Oral Suspension for Sheep Closantel Oxfendazole 50 mg/ml 25 mg/ml Oral suspension oral Sheep Ireland Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Duotech Oral Suspension for Sheep Closantel Oxfendazole 50 mg/ml 25 mg/ml Oral suspension oral Sheep Ireland Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Endex 19,5 % Triclabendazole Levamisole 120 mg/ml 75 mg/ml Oral suspension oral Cattle Ireland Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Endex 8,75 % Triclabendazole Levamisole 50 mg/ml 35 mg/ml Oral suspension oral Sheep Ireland Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Fasinex 10 % Triclabendazole 100 mg/ml Oral suspension oral Cattle Ireland Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Fasinex 10 % for Sheep Triclabendazole 100 mg/ml Oral suspension oral Sheep Ireland Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Fasinex 5 % Triclabendazole 50 mg/ml Oral suspension oral Sheep Ireland Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Fasinex 24 % Triclabendazole 240 mg/ml Oral suspension oral Cattle Ireland Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Fasinex Super 19,5 % Triclabendazole Levamisole 120 mg/ml 75 mg/ml Oral suspension oral Cattle Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digit Park Citywest Business Campus Dublin 24 IRELAND Cydectin Triclamox Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral suolution oral Sheep Ireland PharVet Ltd Station Road Bagenalstown Co. Carlow IRELAND Fenafluke 5 % Rafoxanide Fenbendazole 50 mg/ml 50 mg/ml Oral suspension oral Cattle, Sheep Ireland PharVet Ltd Station Road Bagenalstown Co. Carlow IRELAND Triazole Rafoxanide Levamisole 22,5 mg/ml 15 mg/ml Oral suspension oral Cattle, Sheep Ireland Quinn’s Chemist Bridge Street Crossmolina Co. Mayo IRELAND Fluken worm Rafoxanide Levamisole 22,5 mg/ml 15 mg/ml Oral suspension oral Cattle, Sheep Ireland Univet Limited Tullyvin Cootehill Co. Cavan IRELAND Curafluke 10 % Rafoxanide Fenbendazole 100 mg/ml 100 mg/ml Oral suspension oral Cattle Ireland Univet Limited Tullyvin Cootehill Co. Cavan IRELAND Curafluke 5 % Rafoxanide Fenbendazole 50 mg/ml 50 mg/ml Oral suspension oral Cattle, Sheep Ireland Univet Limited Tullyvin Cootehill Co. Cavan IRELAND Flukex 9 % Rafoxanide 90 mg/ml Oral suspension oral Cattle Ireland Univet Limited Tullyvin Cootehill Co. Cavan IRELAND Univet Multidose Fluke and Worm Rafoxanide Levamisole 22,5 mg/ml 15 mg/ml Oral suspension oral Cattle, Sheep Ireland Virbac S.A. Virbac 1, 1ère Avenue 2065 M - L.I.D., BP 27, 06516 Carros, Cedex FRANCE Virbamec super Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Italy Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Maximec Plus Clorsulon Ivermectin Information not available Solution for injection Information not available Cattle Italy FATRO S.p.A. Via Emilia 285 40064 Ozzano Emilia (BO) ITALY Tolomec Plus Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Italy Pfizer Italia s.r.l. Via Isonzo 71 LATINA ITALY Cydectin Triclamox Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral solution oral Sheep Italy Intervet Production s.r.l. via Nettunense km 20,300 Aprilia (LT) ITALY Ranigel Rafoxanide 75 mg/ml Solution for injection subcutaneous Cattle Italy Intervet Production s.r.l. via Nettunense km 20300 Aprilia (LT) ITALY Ranigel Rafoxanide 30 mg/ml Oral suspension oral Cattle, Sheep Italy Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver Closantel 50 mg/ml Solution for injection intramuscular Cattle Italy Janssen-Cilag S.p.A. Via M. Buonarroti 23 20093 Cologno Monzese (MI) ITALY Seponver Closantel 50 mg/ml Oral suspension oral Sheep Italy Janssen-Cilag S.p.A. Via M. Buonarroti 23 20093 Cologno Monzese (MI) ITALY Seponver Plus Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep Italy Merial Italia S.p.A. via Vittorio Pisani, 16 20100 Milano ITALY Ivomec Plus Clorsulon Ivermectin 100 mg/ml 1 mg/ml Solution for injection subcutaneous Cattle Italy Norbrook Laboratories Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Duotech Closantel Oxfendazole 50 mg/ml 25 mg/ml Oral suspension oral Sheep Italy Norbrook Laboratories Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Sheep Italy Norbrook Laboratories Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Pour on Closantel Ivermectin Information not available Information not available Information not available Information not available Italy Pfizer Italia s.r.l. Via Isonzo 71 LATINA ITALY Cydectin Triclamox Pour on Triclabendazole Moxidectin Information not available Pour-on pour-on Cattle Italy Virbac de Portugal Laboratorios LDA Rua do Centro Empresarial Ed. 13, Quinta da Beloura 2710-693 Sintra PORTUGAL Virbamec F Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Latvia Merial S.A.S. 29 Avenue Tony Garnier 69007 Lyon FRANCE Ivomec Super solution for injection Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Lithuania Merial S.A.S. 29 Avenue Tony Garnier 69007 Lyon FRANCE Ivomec Super solution for injection Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Luxembourg Merial Belgium S.A. Boulevard Sylvain Dupuis 243 B-1070 Bruxelles BELGIUM Ivomec F Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Luxembourg Pfizer Animal Health S.A. rue Laid Burniat 1 1348 Luvain-la-Neuve BELGIUM Cydectin Triclamox Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral solution oral Sheep Norway Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Duotech vet Closantel Oxfendazole 50 mg/ml 25 mg/ml oral suspension oral Sheep Portugal Esteve Farma LDA Av. Do Forte, 3 Edifício Suécia III, Piso 1 2794-044 Carnaxide PORTUGAL Flukiver 50 mg/ml solução injectável para bovinos e ovinos Closantel 50 mg/ml Solution for injection subcutaneous Cattle, Sheep Portugal Esteve Farma LDA Av. Do Forte, 3 Edifício Suécia III, Piso 1 2794-044 Carnaxide PORTUGAL SEPONVER PLUS (75 mg + 50 mg) suspensão oral para ovinos Closantel Mebendazol 50 mg/ml 75 mg/ml Oral suspension oral Sheep Portugal Esteve Farma LDA Av. Do Forte, 3 Edifício Suécia III, Piso 1 2794-044 Carnaxide PORTUGAL Flukiver 5 % suspensão oral Closantel 50 mg/ml Oral suspension oral Cattle, Sheep Portugal Merial Portuguesa Saúde Animal, Lda Av. Maria Lamas, Lt.19 - BL A - Piso 2 - Serra das Minas 2635-432 Rio de Mouro PORTUGAL DOVENIX Nitroxinil 250 mg/ml Solution for injection subcutaneous Cattle, Sheep Portugal Merial Portuguesa Saúde Animal, Lda Av. Maria Lamas, Lt.19 - BL A - Piso 2 - Serra das Minas 2635-432 Rio de Mouro PORTUGAL IVOMEC F Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Portugal Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Duotech Suspensão Closantel Oxfendazole 50 mg/ml 25 mg/ml Oral suspension oral Sheep Portugal Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin FF, solução injectável para bovinos Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle Portugal Virbac de Portugal Laboratórios LDA Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2 2080-104 Almeirim PORTUGAL Virbamec F Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Romania Bomac Laboratories Limited Cnr Wiri Station Road & Hobill Ave P.O Box 76-369 Manukau City Auckland NEW ZEALAND Clos-Atak Closantel 50 mg/ml Solution for injection Intramuscular/subcutaneous Cattle, Sheep Romania Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer THE NETHERLANDS Ranigel Rafoxanide 30 mg/ml Oral suspension oral Cattle, Sheep Romania Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer THE NETHERLANDS Fluxacur Triclabendazole Abamectin Information not available Oral suspension oral Cattle Sheep Romania Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver 5 % Closantel 50 mg/ml Solution for injection subcutaneous Cattle Romania Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver Combi Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep Romania Kepro B.V. Maagdenburgstraat 38 7421 ZE Deventer THE NETHERLANDS Kepromec Super Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Romania Merial S.A.S. 29 Avenue Tony Garnier 69007 Lyon FRANCE IVOMEC PLUS Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Romania Merial S.A.S. 29 Avenue Tony Garnier 69007 Lyon FRANCE DOVENIX Nitroxinil 25 g/100 ml Solution for injection injectable solution Cattle, Sheep, Goats Romania Pasteur - Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud. Prahova ROMANIA Evomec Plus Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Romania Pasteur - Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud. Prahova ROMANIA Helmizol Plus Clorsulon 120 mg/bolus Bolus oral Cattle Romania S.C. Romvac Company s.a. Șos. Centurii, nr. 7 Voluntari ROMANIA Fasciocid Triclabendazole 100 mg/ml Oral solution oral Cattle, Sheep Romania S.C. Romvac Company s.a. Șos. Centurii, nr. 7 Voluntari ROMANIA Romavermectina B1 1 % Plus Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Romania Vanelli S.R.L. Iași-Tg. Frumos, km. 10 Iași ROMANIA Ascacid Forte Rafoxanide Albendazole 25 mg/ml 28 mg/ml Oral suspension oral Cattle, Sheep Romania VIM Spectrum S.R.L. Sos. Sighisoarei nr. 409 Tg. Mures ROMANIA Distol Triclabendazole Ivermectin 500 mg/tablet 10 mg/tablet Tablets oral Sheep, Goats Slovak Republic Chanelle Pharmaceuticals Manufacturing Ltd. IDA Business & Technology Park Loughrea, Co. Galway IRELAND Triclaben 100 mg/ml por.sus.ad us.vet. Triclabendazole 100 mg/ml Oral suspension oral Cattle Slovak Republic Merial S.A.S. 29 Avenue Tony Garnier 69007 Lyon FRANCE Ivomec Super inj. ad us.vet. Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Slovak Republic Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin inj. ad us.vet. Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle Slovak Republic Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin injekčný roztok pre ovce Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Sheep Slovak Republic Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin 5 mg/ml + 200 mg/ml Pour on solution for Cattle Closantelum Ivermectinum 200 mg/ml 5 mg/ml Pour on pour-on Cattle Slovenia KRKA tovarna zdravil, d.d. Šmarješka cesta 6 8501 Novo Mesto SLOVENIA Fascoverm Closantel 50 mg/ml Solution for injection subcutaneous Cattle, Sheep Slovenia KRKA tovarna zdravil, d.d. Šmarješka cesta 6 8501 Novo Mesto SLOVENIA FASCOVERM PLUS Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep Spain C & H Generics Limited c/o Michael McEvoy & Co Seville House New Dock Street Galway IRELAND Chanectin Ivermectin Clorsulon Information not available Information not available Information not available Cattle Spain Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Tribex 10 % Suspension Oral Para Bovino Triclabendazole 100 mg/ml Oral suspension oral Cattle Spain Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Animec Plus Solución inyectable para bovino Clorsulon Ivermectin Information not available Information not available Information not available Information not available Spain Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Tribex 5 % Solución Oral Para Ovino Triclabendazole 50 mg/ml Oral suspension oral Sheep Spain Chanelle Pharmaceuticals Manufacturing Ltd. IDA Business & Technology Park Loughrea, Co. Galway IRELAND Alverin Plus solution for injection for cattle Clorsulon Ivermectin Information not available Information not available Information not available Information not available Spain Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Bimectin Plus Clorsulon Ivermectin Information not available Information not available Information not available Information not available Spain Diana S.A.E. Ctra Barcelona-Ripoll, PK 17 08150 Parets Del Valles, Barcelona SPAIN Vermifor Ecto Closantel 5 g/100 ml Solution for injection Intramuscular/subcutaneous/ Cattle, Sheep Spain FATRO Iberica, S.L. C/ Constitución 1, Planta Baja 3 08960 Sant Just Desvern Barcelona SPAIN Fugosantel Closantel 5 g/100 ml Solution for injection Intramuscular/subcutaneous Cattle, Sheep Spain Industrial Veterinaria, S.A. Esmeralda, 19 E-08950 Esplugues de Llobregat (Barselona) SPAIN Rolenol Closantel 50 mg/ml Solution for injection Intramuscular/subcutaneous Cattle, Sheep Spain Laboratorios Cenavisa, s.a. Cami Pedro Estela, S/N 43205 Reus (Tarragona) SPAIN Telcen Closantel 50 mg/ml Solution for injection Intramuscular/subcutaneous Cattle, Sheep Spain Laboratorios Dr. Esteve S.A. Avda. Mare de Déu de Montserrat 221 08041 Barcelona SPAIN Flukiver Closantel 5 g/100 ml Solution for injection subcutaneous Cattle, Sheep Spain Laboratorios Dr. Esteve S.A. Avda. Mare de Déu de Montserrat 221 08041 Barcelona SPAIN Seponver Plus Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep Spain Laboratorios e Industrias IVEN S.A. C/ Luis I 56 Pol. Ind. De Vallecas Madrid SPAIN Endoectiven Closantel 50 mg/ml Solution for injection Intramuscular/subcutaneous Cattle, Sheep Spain Laboratorios Hipra S.A. Avda. La Selva 135 17170 Amer (Gerona) SPAIN Leclosan Closantel 50 mg/ml Solution for injection Intramuscular/subcutaneous Cattle, Sheep Spain Laboratorios Ovejero, S.A. Ctra León - Vilecha, 30 24192 León SPAIN Distomicide Nitroxinil 25 g/100 ml Solution for injection subcutaneous Cattle, Sheep Spain Merial Laboratorios S.A. C/ Tarragona n.161 Locales D/E 08014 Barcelona SPAIN Dovenix Nitroxinil 25 g/100 ml Solution for injection subcutaneous Cattle, Sheep Spain Merial Laboratorios S.A. C/ Tarragona n.161 Locales D/E 08014 Barcelona SPAIN Ivomec F Clorsulon 100 mg/ml Solution for injection subcutaneous Cattle Spain Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin pour-on Closantel Invermectine Information not available Information not available pour-on Cattle Spain Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Duotech suspensión oral Closantel Oxfendazol 50 mg/ml 25 mg/ml Oral suspension oral Sheep Spain Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Solucion Inyectable para Bovino Closantel Invermectine 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle Spain Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Solucion Inyectable para Ovino Closantel Invermectine 125 mg/ml 5 mg/ml Solution for injection subcutaneous Sheep Spain Novartis Sanidad Animal S.L. C/ De La Marina 206 08013 Barcelona SPAIN Endex 19,5 % Triclabendazole 12 g/100 ml Oral suspension oral Cattle Spain Novartis Sanidad Animal S.L. C/ De La Marina 206 08013 Barcelona SPAIN Fasinex 10 % Bovino Triclabendazole 100 mg/ml Oral suspension oral Cattle Spain Novartis Sanidad Animal S.L. C/ De La Marina 206 08013 Barcelona SPAIN Fasinex 5 % Ovino Triclabendazole 5 g/100 ml Oral suspension oral Sheep Spain Novartis Sanidad Animal S.L. C/ De La Marina 206 08013 Barcelona SPAIN Endex 8,57 % Triclabendazole Levamisole 5 g/100 ml 3,75 g/100 ml Oral suspension oral Sheep Spain Novartis Sanidad Animal S.L. C/ De La Marina 206 08013 Barcelona SPAIN Fasinex 10 % Ovino Triclabendazole 100 mg/ml Oral suspension oral Sheep Spain Pfizer S.L. Avenida de Europa 20 B Parque Empresarial La Moraleja Alcobendas Madrid SPAIN Cydectin Triclamox 5 mg/ml + 200 mg/ml Pour On Solution For Cattle Triclabendazole Moxidectin Information not available Information not available Information not available Information not available Spain Pfizer S.L. Avenida de Europa 20 B Parque Empresarial La Moraleja Alcobendas Madrid SPAIN Cydectin Triclamox 1 mg/ml + 50 mg/ml Solución Oral Para Ovino Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral solution oral Sheep Spain S.P. Veterinaria S.A. Ctra Reus a Vinyols Km.4,1 43330 Riudoms (Tarragona) SPAIN Endoex Inyectable Closantel 5 g/100 ml Solution for injection Intramuscular/subcutaneous Cattle, Sheep Spain S.P. Veterinaria S.A. Ctra Reus a Vinyols Km.4,1 43330 Riudoms (Tarragona) SPAIN Endoex Oral Closantel 5 g/100 ml Oral solution oral Cattle, Sheep Spain Virbac de Portugal Laboratórios LDA Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2 2080-104 Almeirim PORTUGAL Virbamec F Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle Sweden Pfizer Oy Animal Health Tietokuja 4 00330 Helsinki FINLAND Moxidektin/ Triklabendazol Fort Dodge Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral solution oral Sheep The Netherlands Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Tribex 5 % orale suspensie voor schapen Triclabendazole 50 mg/ml Oral suspension oral Sheep The Netherlands Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Tribex 10 % orale suspensie voor rundvee Triclabendazole 100 mg/ml Oral suspension oral Cattle The Netherlands Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver 50 mg/ml, oplossing voor injectie Closantel 50 mg/ml Solution for injection subcutaneous Cattle The Netherlands Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM Flukiver combi orale suspensie voor schapen en lammeren Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep, Lambs The Netherlands Merial B.V. Kleermakersstraat 10 1191 JL Velserbroek THE NETHERLANDS Ivomec Plus Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection oral Cattle The Netherlands Novartis Consumer Health B.V. Claudius Prinsenlaan 142 4818 CP Breda THE NETHERLANDS Endex 19,5 % Triclabendazole Levamisole 120 mg/ml 75 mg/ml Oral suspension oral Cattle The Netherlands Novartis Consumer Health B.V. Claudius Prinsenlaan 142 4818 CP Breda THE NETHERLANDS Endex 8,75 % Triclabendazole Levamisole 50 mg/ml 37,5 mg/ml Oral suspension oral Sheep The Netherlands Novartis Consumer Health B.V. Claudius Prinsenlaan 142 4818 CP Breda THE NETHERLANDS Fasinex 10 % Triclabendazole 10 g/100 ml Oral suspension oral Cattle The Netherlands Novartis Consumer Health B.V. Claudius Prinsenlaan 142 4818 CP Breda THE NETHERLANDS Fasinex 5 % Triclabendazole 5 g/100 ml Oral suspension oral Sheep The Netherlands Pfizer Animal Health B.V. Rivium Westlaan 142 2909 LD Capelle a/d Ijssel THE NETHERLANDS Cydectin Triclamox 1 mg/ml + 50 mg/ml orale oplossing voor schapen Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral solution oral Sheep The Netherlands Schippers Europe B.V. Rond Deel 12 5531 AH Bladel THE NETHERLANDS Endex Triclabendazole Levamisole 50 mg/ml 37,5 mg/ml Oral suspension oral Sheep The Netherlands Virbac de Portugal Laboratorios LDA Rua do Centro Empresarial Ed. 13, Quinta da Beloura 2710-693 Sintra PORTUGAL Virbamec F. oplossing voor injectie Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle The Netherlands Wirtz Farma B.V. Leijsendwarsstraat 26 4901 PG, Oosterhout THE NETHERLANDS Endex Suspensie Triclabendazole Levamisole 50 mg/ml 37,5 mg/ml Oral suspension oral Sheep The Netherlands Wirtz Farma B.V. Leijsendwarsstraat 26 4901 PG, Oosterhout THE NETHERLANDS Fasinex 5 % Triclabendazole 5 g/100 ml Oral suspension oral Sheep The Netherlands Wirtz Farma B.V. Leijsendwarsstraat 26 4901 PG, Oosterhout THE NETHERLANDS Fasinex 10 % Triclabendazole 10 g/100 ml Oral suspension oral Cattle United Kingdom Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Alverin Plus Solution for Injection for Cattle Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle United Kingdom Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Animec Super Solution for Injection for Cattle Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle United Kingdom Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Tribex 5 % Oral Suspension for Sheep Triclabendazole 50 mg/ml Oral suspension oral Sheep United Kingdom Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Tribex 10 % Oral Suspension for Cattle Triclabendazole 100 mg/ml Oral suspension oral Cattle United Kingdom Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Triclacert 5 % Oral Suspension for Sheep Triclabendazole 50 mg/ml Oral suspension oral Sheep United Kingdom Chanelle Animal Health Limited 7 Rodney Street Liverpoool L1 9HZ UNITED KINGDOM Triclacert 10 % Oral Suspension for Cattle Triclabendazole 100 mg/ml Oral suspension oral Cattle United Kingdom Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Bimectin Plus Solution for Injection for Cattle Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle United Kingdom Cross Vet Pharm Group Ltd Broomhill Road Tallaght Dublin 24 IRELAND Endofluke 100 mg/ml Oral Suspension Triclabendazole 100 mg/ml Oral suspension oral Cattle, Sheep United Kingdom Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UNITED KINGDOM Flukiver 5 % w/v Oral Suspension Closantel 50 mg/ml Oral suspension oral Sheep United Kingdom Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UNITED KINGDOM Flukiver Bovis 50 mg/ml Solution for Injection Closantel 50 mg/ml Solution for injection subcutaneous Cattle United Kingdom Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UNITED KINGDOM Mebadown Super Oral Suspension Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep, Lambs United Kingdom Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UNITED KINGDOM Supaverm Oral Suspension Closantel Mebendazole 50 mg/ml 75 mg/ml Oral suspension oral Sheep United Kingdom Merial Animal Health Limited Sandringham House Sandringham Avenue, Harlow Business Park, Harlow CM19 5TG Essex UNITED KINGDOM Ivomec Super Injection for Cattle Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle United Kingdom Merial Animal Health Limited Sandringham House Sandringham Avenue, Harlow Business Park, Harlow CM19 5TG Essex UNITED KINGDOM Trodax 34 % w/v Solution for Injection Nitroxinil 340 mg/ml Solution for injection subcutaneous Cattle, Sheep United Kingdom Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Pour-on Solution for Cattle Closantel Ivermectin 200 mg/ml 5 mg/ml Pour-on pour-on Cattle United Kingdom Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Solution for Injection Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle United Kingdom Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closamectin Solution for Injection for Sheep Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Sheep United Kingdom Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closiver Pour-on Solution for Cattle Closantel Ivermectin 200 mg/ml 5 mg/ml Pour-on pour-on Cattle United Kingdom Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closiver Solution for Injection for Cattle Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle United Kingdom Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closiver Solution for Injection for Sheep Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Sheep United Kingdom Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Closivet Solution for Injection for Cattle Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle United Kingdom Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Norofas Pour-On Closantel Ivermectin 200 mg/ml 5 mg/ml Pour-on pour-on Cattle United Kingdom Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Norofas Solution for Injection Closantel Ivermectin 125 mg/ml 5 mg/ml Solution for injection subcutaneous Cattle United Kingdom Norbrook Laboratories Ltd Station Works Camlough Road Newry, County Down BT35 6JP Northern Ireland UNITED KINGDOM Triclafas Drench 5 % w/v Oral Suspension Triclabendazole 50 mg/ml Oral suspension oral Sheep United Kingdom Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Combinex Cattle Oral Suspension Triclabendazole Levamisole 120 mg/ml 75 mg/ml Oral suspension oral Cattle United Kingdom Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Combinex Oral Suspension Triclabendazole Levamisole 50 mg/ml 37,5 mg/ml Oral suspension oral Sheep United Kingdom Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Fasimec Duo S 0,1 %/5 % Oral Suspension for Sheep Triclabendazole Ivermectin 50 mg/ml 1 mg/ml Oral suspension oral Sheep United Kingdom Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Fasinex 5 % w/v Oral Suspension Triclabendazole 50 mg/ml Oral suspension oral Sheep United Kingdom Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Fasinex 10 % Oral Suspension for Cattle Triclabendazole 100 mg/ml Oral suspension oral Cattle United Kingdom Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Fasinex 100 10 %(w/v) Oral Suspension for Cattle and Sheep Triclabendazole 100 mg/ml Oral suspension oral Cattle, Sheep United Kingdom Novartis Animal Health United Kingdom Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UNITED KINGDOM Fasinex 240, 24 % w/v Oral Suspension for Cattle Triclabendazole 240 mg/ml Oral suspension oral Cattle United Kingdom Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM Cydectin TriclaMox 1 mg/ml + 50 mg/ml Oral Solution for Sheep Triclabendazole Moxidectin 50 mg/ml 1 mg/ml Oral solution oral Sheep United Kingdom Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle Triclabendazole Moxidectin 200 mg/ml 5 mg/ml Pour-on Information not available Cattle United Kingdom Virbac de Portugal Laboratórios LDA Rua Dionísio Saraiva, Lote 1, 1o Andar, Sala 2 2080-104 Almeirim PORTUGAL Supremadex Solution for Injection Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle United Kingdom Virbac Ltd Woolpit Business Park Windmill Avenue Woolpit Bury St Edmunds Suffolk IP30 9UP UNITED KINGDOM Virbamec Super Solution for Injection Clorsulon Ivermectin 100 mg/ml 10 mg/ml Solution for injection subcutaneous Cattle

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing Authorisation holder (Invented) name Strengths Phramaceutical form Route of administration Austria Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland Leflunomid Actavis 10 mg Filmtabletten 10 mg Film-coated tablet Oral use Austria Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland Leflunomid Actavis 100 mg Filmtabletten 100 mg Film-coated tablet Oral use Austria Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland Leflunomid Actavis 20 mg Filmtabletten 20 mg Film-coated tablet Oral use Czech Republic Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland LEFLUNOMID ACTAVIS 10 MG 10 mg Film-coated tablet Oral use Czech Republic Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland LEFLUNOMID ACTAVIS 100 MG 100 mg Film-coated tablet Oral use Czech Republic Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland LEFLUNOMID ACTAVIS 20 MG 20 mg Film-coated tablet Oral use The Netherlands Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland Leflunomide Actavis 10 mg, filmomhulde tabletten 10 mg Film-coated tablet Oral use The Netherlands Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland Leflunomide Actavis 100 mg, filmomhulde tabletten 100 mg Film-coated tablet Oral use The Netherlands Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland Leflunomide Actavis 20 mg, filmomhulde tabletten 20 mg Film-coated tablet Oral use