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 or Article 38 of Directive 2001/82/EC)
Date: 2012-12-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2012401EN.01000901.xml










28.12.2012   


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







ANNEX IV

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


Strength


Pharmaceutical form


Route of administration




Belgium







Apotex Europe BV




Darwinweg 20




2333 CR Leiden




The Netherlands






Leflunomide Apotex


10 mg


Tablet


Oral use




Belgium







Apotex Europe BV




Darwinweg 20




2333 CR Leiden




The Netherlands






Leflunomide Apotex


20 mg


Tablet


Oral use




Czech Republic







Apotex Europe BV




Darwinweg 20




2333 CR Leiden




The Netherlands






LEFLUNOMID APOTEX 10 MG


10 mg


Tablet


Oral use




Czech Republic







Apotex Europe BV




Darwinweg 20




2333 CR Leiden




The Netherlands






LEFLUNOMID APOTEX 20 MG


20 mg


Tablet


Oral use




The Netherlands







Apotex Europe BV




Darwinweg 20




2333 CR Leiden




the Netherlands






Leflunomide Apotex 10 mg, tabletten


10 mg


Tablet


Oral use




The Netherlands







Apotex Europe BV




Darwinweg 20




2333 CR Leiden




the Netherlands






Leflunomide Apotex 20 mg, tabletten


20 mg


Tablet


Oral use




Spain







Apotex Europe BV




Darwinweg 20




2333 CR Leiden




The Netherlands






LEFLUNOMIDA APOTEX 10 mg comprimidos EFG


10 mg


Tablet


Oral use




Spain







Apotex Europe BV




Darwinweg 20




2333 CR Leiden




The Netherlands






LEFLUNOMIDA APOTEX 20 mg comprimidos EFG


20 mg


Tablet


Oral use