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ANEXA I LISTA DENUMIRILOR, CONCENTRAIILE MEDICAMENTELOR DE UZ VETERINAR, SPECIILE DE ANIMALE, CALEA DE ADMINISTRARE, DOZELE RECOMANDATE I TITULARII AUTORIZAIEI DE INTRODUCERE

PE PIA DIN STATELE MEMBRE

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Stat membru Austria

Titularul autorizaiei de introducere pe pia i adresa Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Laboratorios Calier SA Barcelones 26 (Pla del Ramassa) 08520 Les Franqueses del Valles Barcelona Spain MERIAL 29 avenue Tony Garnier 69007 LYON France

Denumirea inventat Animec injection Injektionslng fr Rinder und Schweine

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Austria

Bimectin

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Austria

Ecomectin

Ivermectin 10 mg/ml

Bovine, ovine

Subcutanat

Austria

Ivertin

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Austria

Ivomec 10 mg/ml Injektionssuspension fr Rinder, Schafe und Schweine

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

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Stat membru Austria

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland

Denumirea inventat Noromectin Injektionslsung fr Tiere

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Austria

Qualimec

Ivermectin 10 mg/ml

Bovine, ovine

Subcutanat

Austria

VIRBAMEC Injektionslsung Fr Tiere: Rinder, Schafe, Schweine

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Austria

Closamectin Injektionlsung fr Rinder

Ivermectin 5 mg/ml, closantel 125 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

Belgia

BOVIMEC B

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

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Stat membru Belgia

Titularul autorizaiei de introducere pe pia i adresa ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Laboratorios Calier SA Barcelones 26 (Pla del Ramassa) 08520 Les Franqueses del Valles Barcelona Spain MERIAL Belgium S.A. Bld Sylvain Dupuis 243 1070 Bruxelles Belgium Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal

Denumirea inventat ECOMECTIN 10MG/ML

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Belgia

IVERTIN CATTLE

Ivermectin 10 mg/ml

Bovine

Subcutanat

Belgia

IVOMEC F

Belgia

Noromectin

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Bovine, porcine

Subcutanat

Belgia

VIRBAMEC 1 % Solution injectable

Ivermectin 10 mg/ml

Bovine, ovine

Subcutanat

Belgia

VIRBAMEC F solution injectable

Ivermectin 10 mg/ml, clorsulon 100 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal

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Stat membru Belgia

Titularul autorizaiei de introducere pe pia i adresa MERIAL Belgium S.A. Bld Sylvain Dupuis 243 1070 Bruxelles Belgium ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Intervet International B.V. Wim de Korvrstraat 35, 5831 AA, Boxmeer, The Netherlands

Denumirea inventat Ivomec

Concentra ii Ivermectin 10 mg/ml Ivermectin 10 mg/ml

Specii de animale Bovine, ovine Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Belgia

QUALIMEC 10MG/ML

Subcutanat

Belgia

Closamectin Oplossing voor Injectie voor rundvee

Ivermectin 5 mg/ml, closantel 125 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

Bulgaria

Ivotan LA

Bovine, ovine, caprine, porcine

Subcutanat

Bovine, ovine, caprine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine, caprine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Bulgaria

Ceva Sante Animale La Ballastiere B.P. 126 33501 Libourne Cedex France

Cevamec 1% injectable solution

Ivermectin 10 mg/ml

Bovine, ovine, caprine, porcine

Subcutanat

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Stat membru Bulgaria

Titularul autorizaiei de introducere pe pia i adresa Alfasan International B.V., P.O. Box 78, 3440 AB Woerden, The Netherlands

Denumirea inventat Alfamec 1 %

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine, caprine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal Bovine, ovine, caprine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Bulgaria

BIOVET JSC 39 Petar Rakov Str. 4550 Pesthera Bulgaria

Pandex 1 %

Ivermectin 10 mg/ml

Bovine, ovine, caprine, porcine

Subcutanat

Bulgaria

Bulgaria

Centrovet Ltd. Av.Los Cerrilos 602 Santiago, Chile Interchemie werken de Adelaar BV Horsterweg 26A 5811 AC Castenray The Netherlands

Microdes Plus

Intermectin

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

Bovine, ovine, caprine, porcine

Subcutanat

Bulgaria

Invesa International S.A. Esmeralda 19 08950 Esplugues de Llobregat Barcelona Spain

Promectine

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

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Stat membru Bulgaria

Titularul autorizaiei de introducere pe pia i adresa ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Panchris Feeds Ltd. P.O.Box 40261, 6302 Larnaca Cyprus

Denumirea inventat Divamectin 1% Solution for Injection

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Cipru

Bimectin Injection

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Cipru

Cipru

Vetagrica Ltd 3 Othellou Street, 2540 Dhali Industrial Estate Nicosia Cyprus Spyros Stavrinides Chemicals Ltd 28 Stasinou Avenue, 1060 Nicosia, Cyprus

Ivomec Super Injection for Cattle

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

Noromectin injection

Bovine, porcine

Subcutanat

Republica Ceh

Vtoquinol s.r.o., Zmencka 411, 288 02 Nymburk, Czech Republic

Biomectin 1 %

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

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Stat membru Republica Ceh

Titularul autorizaiei de introducere pe pia i adresa Bremer Pharma GmbH Cherbourger Str. 25 27540 Bremerhaven Germany

Denumirea inventat Bremamectin

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine, caprine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Republica Ceh

CEVA Animal Health Slovakia, spol. s r.o. Raianska 77 83 102 BRATISLAVA Slovak Republic

Cevamec 1 % inj. ad us. vet.

Ivermectin 10 mg/ml

Bovine, ovine, caprine, porcine

Subcutanat

Republica Ceh

ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom MERIAL 29 avenue Tony Garnier 69007 LYON France

Ecomectin 1 %

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Republica Ceh

Ivomec 1% inj. ad. us. vet.

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Republica Ceh

MERIAL 29 avenue Tony Garnier 69007 LYON France

Ivomec Super inj. a.u.v.

Ivermectin 10 mg/ml, clorsulon 100 mg/ml

Bovine, ovine

Subcutanat

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Stat membru Republica Ceh

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal Bioveta a.s., Komenskho 212 683 23 Ivanovice na Han Czech Republic

Denumirea inventat Noromectin Inj ad us vet

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Republica Ceh

Virbamec inj. ad us. vet.

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Republica Ceh

Biomec 10 mg/ml Injekn roztok

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Republica Ceh

Danemarca

Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland

Closamectin injekn roztok pro skot

Ivermectin 5 mg/ml, closantel 125 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

Noromectin Vet

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

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Stat membru Danemarca

Titularul autorizaiei de introducere pe pia i adresa

Denumirea inventat

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

Danemarca

Danemarca

Danemarca

Danemarca

Danemarca

Qualimec Vet ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Bimec Vet Bimeda (a division of Cross Vetpharm Group Limited) Broomhill Road Tallaght Dublin 24 Ireland Ecomec vet. ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom VIRBAC DE PORTUGAL Laboratorios Lda Ivermectin Virbac Vet., Rua Dionsio Saraiva, Lote 1, injektionsvske, 1 Andar, Sala 2, oplsning 2080-104 Almeirim Portugal Coopermec Vet ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Merial Norden A/S Ivomec vet., Mileparken 20 E injektionsvske 10 2740 Skovlunde mg/ml Denmark

200 g ivermectin/kg greutate corporal

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

10/71

Stat membru Estonia

Titularul autorizaiei de introducere pe pia i adresa ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom MERIAL 29 avenue Tony Garnier 69007 LYON France Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), Broomhill Road Tallaght Dublin 24 Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Ceva Sante Animale La Ballastiere B.P. 126 33501 Libourne Cedex France Bremer Pharma GmbH Cherbourger Str. 25 27540 Bremerhaven Germany

Denumirea inventat Ecomectin

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Estonia

Ivomec 1% injection, sstelahus

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Estonia

Bimectin injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Estonia

Noromectin Multi Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Estonia

Cevamec 1% injectable solution

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Estonia

Bremamectin

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

11/71

Stat membru Estonia

Titularul autorizaiei de introducere pe pia i adresa Vetoquinol Biowet Sp. z o.o., ul. Kosynierw Gdyskich 13-14, 66-400 Gorzw Wlkp., Poland Scanvet Elinlkkeet Oy PL 27 13721 PAROLA Finland

Denumirea inventat Biomectin 1%

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Finlanda

Animec vet

Ivermectin 10 mg/ml

Bovine, reni, porcine

Subcutanat

Bovine, reni: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, reni: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, reni: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Finlanda

Bimeda (a division of Cross Vetpharm Group Limited) Broomhill Road Tallaght Dublin 24 Ireland MERIAL 29 avenue Tony Garnier 69007 LYON France

Bimectin vet

Ivermectin 10 mg/ml

Bovine, reni, porcine

Subcutanat

Finlanda

Ivomec 10 mg/ml vet injektioneste, liuos

Ivermectin 10 mg/ml

Bovine, reni, porcine

Subcutanat

Finlanda

Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom

Animec injection10 mg/ml solution for injection

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

12/71

Stat membru Finlanda

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal MERIAL 29 avenue Tony Garnier 69007 LYON France MERIAL 29 avenue Tony Garnier 69007 LYON France VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal

Denumirea inventat Noromectin Vet 10mg/ml Solution for Injection

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, reni, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, reni: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, reni: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Finlanda

VIRBAMEC VET 10 mg/ml injektioneste, liuos

Ivermectin 10 mg/ml

Bovine, reni, porcine

Subcutanat

Frana

Ivomec

Ivermectin 10 mg/ml

Bovine

Subcutanat

Frana

IVOMEC D

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal 200 g ivermectin/kg greutate corporal

Frana

VIRBAMEC SOLUTION INJECTABLE POUR BOVINS VIRBAMEC D SOLUTION INJECTABLE

Bovine

Subcutanat

Frana

Ivermectin 10 mg/ml, clorsulon 100 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal

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Stat membru Frana

Titularul autorizaiei de introducere pe pia i adresa VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Laboratorios Calier SA Barcelones 26 (Pla del Ramassa) 08520 Les Franqueses del Valles Barcelona Spain Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland

Denumirea inventat VIRBAMEC Solution Injectable pour Bovins Porins Ovins

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Frana

IVERMECTINE ECO 10 MG/ML SOLUTION I NJECTABLE

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Frana

QUALIMEC 10 MG/ML SOLUTION INJECTABLE

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Frana

IVERTIN BOVIN

Ivermectin 10 mg/ml

Bovine

Subcutanat

Frana

CEVAMEC BOVINS OVINS SOLUTION INJECTABLE

Ivermectin 10 mg/ml

Bovine, ovine

Subcutanat

200 g ivermectin/kg greutate corporal

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Stat membru Frana

Titularul autorizaiei de introducere pe pia i adresa Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom

Denumirea inventat Magamectine iInjectable (?), solution injectable

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Frana

Medimec Injectable, Solution Injectable

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Frana

Noromectin 1% Solution Injectable Bovine, Porcins

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Frana

Closamectine Solution Injectable pour bovins

Ivermectin 5 mg/ml, closantel 125 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

Frana

Divamectin 1% Solution for Injection

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

15/71

Stat membru Germania

Titularul autorizaiei de introducere pe pia i adresa MERIAL GmbH Am Sldnermoos 6 D-85399 Hallbergmoos Germany Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), Broomhill Road Tallaght Dublin 24 Ireland Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), Broomhill Road Tallaght Dublin 24 Ireland Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom

Denumirea inventat Ivomec

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Germania

Chanectin Injektion

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Germania

Diapec R

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Germania

Wedemec R

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Germania

Sumex Injektion fr Rinder

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Germania

Ecomectin 1% Injektion

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

16/71

Stat membru Germania

Titularul autorizaiei de introducere pe pia i adresa VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom

Denumirea inventat Virbamec Inektionslsung

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Grecia

Noromectin 1% 1% Evio iua

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Grecia

Paramectin 1% 1% Evio iua

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Grecia

VIRBAMEC

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Grecia

ECOMECTIN

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

17/71

Stat membru Grecia

Titularul autorizaiei de introducere pe pia i adresa ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland

Denumirea inventat Qualimec

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Grecia

Animec Inj. Sol.

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Grecia

VETERIN ABEE Aspropyrgos Attikis 19300 Greece

VETERMEC

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Grecia

PNG Gerolymatos S.A. 13, Asklipiou 145 68 KRYONERI, ATTICA Greece

VALANEQ

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

18/71

Stat membru Grecia

Titularul autorizaiei de introducere pe pia i adresa Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland SCHERING PLOUGH SA 65,Ag Dimitriou 17455, Athens Greece

Denumirea inventat MAXIMEC

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Grecia

TIZOVAL

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Ungaria

Ungaria

Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland Bayer Hungria Ltd. H-1123 Budapest Alkots u. 50. Hungary Vetoquinol Biowet Sp. z o.o., ul. Kosynierw Gdyskich 13-14, 66-400 Gorzw Wlkp., Poland Ceva-Phylaxia Oltanyagtermel Zrt. Szlls u. 5 1107 Budapest Hungary

Animec Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

Baymec Trio 1%

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Ungaria

Biomectin 1%

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Ungaria

Cevamec 1% injekci A.U.V

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

19/71

Stat membru Ungaria

Titularul autorizaiei de introducere pe pia i adresa Divasa Farmavic Hungaria Ltd. H-6070 Izsk, Kossuth L. u. 60. Hungary Bremer Pharma GmbH. Werkstrasse 42 34414 Warburg-Scherfede Germany Invesa International S.A. Esmeralda 19 08950 Esplugues de Llobregat Barcelona Spain Veterina Polska Sp. Zo.o. Ul. Mogilska 80, 31546 Krakow Poland Laboratorios Calier SA Barcelones 26 (Pla del Ramassa) 08520 Les Franqueses del Valles Barcelona Spain VMD Animal Health Ltd. Kzraktr u. 22/b. II. 3., 1093 Budapest Hungary MERIAL 29 avenue Tony Garnier 69007 LYON France

Denumirea inventat ECOMECTIN

Concentra ii Ivermectin 10 mg/ml Ivermectin 10 mg/ml Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Ungaria

FROMMECTIN

Bovine

Subcutanat

Ungaria

IVERGEN PREMIUM LA

Bovine

Subcutanat

Ungaria

Iverktin Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Ungaria

IVERTIN

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Ungaria

IVERVETo 1 %

Ivermectin 10 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Ungaria

Ivomec injekci A.U.V.

Bovine

Subcutanat

20/71

Stat membru Ungaria

Titularul autorizaiei de introducere pe pia i adresa MERIAL 29 avenue Tony Garnier 69007 LYON France Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom C-Corp, 78 Coombe Road, New Malden, Surrey KT3 4QS, United Kingdom C-Corp, 78 Coombe Road, New Malden, Surrey KT3 4QS, United Kingdom C-Corp, 78 Coombe Road, New Malden, Surrey KT3 4QS, United Kingdom

Denumirea inventat Ivomec super injekci A.U.V.

Concentra ii Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal 200 g ivermectin/kg greutate corporal

Ungaria

Noromectin

Bovine

Subcutanat

Ungaria

Vetimec 10 mg/ml solution for injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Kilo-mec 1% Solution for Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Mastermectin 1 Per Cent

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Coopermec 1% Solution for Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

21/71

Stat membru Irlanda

Titularul autorizaiei de introducere pe pia i adresa VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal Merial Animal Health Limited Sandringham House Harlow Business Park Harlow Essex CM19 5TG United Kingdom Merial Animal Health Limited Sandringham House Harlow Business Park Harlow Essex CM19 5TG United Kingdom

Denumirea inventat Virbamec Injectable Solution

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Irlanda

Virbamec for Cattle Swine and Sheep 1%

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Virbamec Super Solution for Injection

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal

Irlanda

Panomec 1% Solution for Injection for Cattle, Sheep and Pigs Ivomec Classic Injection for Cattle and Sheep 1% w/v

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

22/71

Stat membru Irlanda

Titularul autorizaiei de introducere pe pia i adresa Merial Animal Health Limited Sandringham House Harlow Business Park Harlow Essex CM19 5TG United Kingdom ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom

Denumirea inventat Ivomec Super Injection for Cattle

Concentra ii Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal

Irlanda

Ecomectin 1% Solution for Injection

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Qualimec 10 mg/ml Solution for Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Fatromectin 1% Solution for Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Divamectin 1% Solution for Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Chanimec Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

23/71

Stat membru Irlanda

Titularul autorizaiei de introducere pe pia i adresa Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom

Denumirea inventat Animec 1% solution Injection

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Irlanda

Chanectin Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Sumex Injection for Cattle, 1%, Solution for injection for Cattle Anisec Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Aniject Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Chaniject Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

24/71

Stat membru Irlanda

Titularul autorizaiei de introducere pe pia i adresa Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland

Denumirea inventat Sumiject Injection

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Irlanda

Medimec Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Topimec Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Bimectin 1.0 %w/v Solution for Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Mectaject 1.0 % Solution for Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Bovimectin 1% solution for injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

25/71

Stat membru Irlanda

Titularul autorizaiei de introducere pe pia i adresa Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland

Denumirea inventat Maximec Injection for Cattle & Sheep

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Irlanda

Trimectin Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Bovimec 1.0% w/v Solution for Injection for Cattle Paramectin 1% Solution for Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Noromectin Multi Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Primectin 1% w/v Solution for Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

26/71

Stat membru Irlanda

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland MERIAL 29 avenue Tony Garnier 69007 LYON France

Denumirea inventat

Concentra ii

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

Closamectin Solution Ivermectin for Injection 5 mg/ml, closantel 125 mg/ml Enovex Injection 1% w/v Ivermectin 10 mg/ml

200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Irlanda

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Noromectin 1% Solution for Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Irlanda

Closiver Injection

Ivermectin 5 mg/ml, closantel 125 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Islanda

Ivomec vet.

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

27/71

Stat membru Italia

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Laboratorios Calier SA Barcelones 26 (Pla del Ramassa) 08520 Les Franqueses del Valles Barcelona Spain INTERVET PRODUCTIONS SRL Via Nettunense km 20, 300 04011 Aprilia Italy

Denumirea inventat Baymec 1% Soluzione

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Italia

Noromectin Injection

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Italia

Ivertin Cattle

Ivermectin 10 mg/ml

Bovine

Subcutanat

Italia

Ivogell

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Italia

Merial Italia S.p.A. a Socio Unico, Via Vittor Pisani, 16 Milano Italy

Ivomec

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

28/71

Stat membru Italia

Titularul autorizaiei de introducere pe pia i adresa Merial Italia S.p.A. a Socio Unico, Via Vittor Pisani, 16 Milano Italy Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland Fatro Via Emilia, 285 40064 Ozzano Emilia (Bologna) Italy

Denumirea inventat Ivomec Plus

Concentra ii Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal

Italia

Maximec iniettable

Bovine, ovine, porcine

Subcutanat

Italia

Tolomec

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Italia

VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal

VIRBAMEC Soluzione iniettabile

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Italia

VIRBAMEC F soluzione iniettabile

Ivermectin 10 mg/ml, clorsulon 100 mg/ml

Bovine

Subcutanat

29/71

Stat membru Italia

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland

Denumirea inventat Closamectin Soluzione iniettabile per bovini

Concentra ii Ivermectin 5 mg/ml, closantel 125 mg/ml Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Italia

Divamectin 1% Solution for Injection

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Letonia

Animec Injection

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Letonia

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), Broomhill Road Tallaght Dublin 24 Ireland Vetoquinol Biowet Sp. z o.o., ul. Kosynierw Gdyskich 13-14, 66-400 Gorzw Wlkp., Poland

Bimectin Injection

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Letonia

Biomectin 1%

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

30/71

Stat membru Letonia

Titularul autorizaiei de introducere pe pia i adresa Ceva Sante Animale La Ballastiere B.P. 126 33501 Libourne Cedex France ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom MERIAL 29 avenue Tony Garnier 69007 LYON France

Denumirea inventat Cevamec 1%

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Letonia

Ecomectin 10 mg/ml

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Letonia

IVOMEC 1% Injection

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Letonia

MERIAL 29 avenue Tony Garnier 69007 LYON France Pharmaceutical Company PFO "VETOS-FARMA" sp. z.o.o., Dzierzoniwska street 21 58-260 Bielawa Poland

Ivomec Plus

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

Letonia

Iwermektyna 1% Injection

Bovine, ovine, porcine

Subcutanat

31/71

Stat membru Letonia

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland MERIAL 29 avenue Tony Garnier 69007 LYON France MERIAL 29 avenue Tony Garnier 69007 LYON France

Denumirea inventat Noromectin Injection

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Lituania

IVOMEC PLUS, injekcinis tirpalas

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine, ovine

Subcutanat

Lituania

IVOMEC 1%, injekcinis tirpalas

Bovine, ovine, porcine

Subcutanat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine, caprine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Lituania

Vetoquinol Biowet Sp. z o.o., ul. Kosynierw Gdyskich 13-14, 66-400 Gorzw Wlkp., Poland

Biomectin 1%, injekcinis tirpalas

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Lituania

Ceva Sante Animale La Ballastiere B.P. 126 33501 Libourne Cedex France

Cevamec 1%, injekcinis tirpalas

Ivermectin 10 mg/ml

Bovine, ovine, caprine, porcine

Subcutanat

32/71

Stat membru Lituania

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Invesa International S.A. Esmeralda 19 08950 Esplugues de Llobregat Barcelona Spain Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), Broomhill Road Tallaght Dublin 24 Ireland ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom MERIAL Belgium S.A. Bld Sylvain Dupuis 243 1070 Bruxelles Belgium

Denumirea inventat Noromectin Injekcinis tirpalas

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Lituania

PROMECTINE

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Lituania

BIMECTIN

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Lituania

ECOMECTIN 10 mg/ml

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Luxemburg

Ivomec solution pour injection

Ivermectin 10 mg/ml

Bovine, ovine

Subcutanat

33/71

Stat membru Luxemburg

Titularul autorizaiei de introducere pe pia i adresa ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal

Denumirea inventat Ecomectin 1%

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Luxemburg

Noromectin 1% inj.sol. bovine and porcine

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Bovine: 200 g ivermectin/kg greutate corporal Porcine 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Luxemburg

Paramectin 1% solution for injection

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Luxemburg

Qualimec 1% solution for injection

Ivermectin 10 mg/ml

Bovine, ovine

Subcutanat

Luxemburg

Virbamec solution pour injection bovine

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

34/71

Stat membru Malta

Titularul autorizaiei de introducere pe pia i adresa Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland Laboratorios HIPRA S.A. Avda. La Selva, 135 17170 Amer, Girona Spain Interchemie werken de Adelaar BV Horsterweg 26A 5811 AC Castenray The Netherlands

Denumirea inventat Bimectin

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Malta

Iveripra-I

Ivermectin 10 mg/ml

Bovine

Subcutanat

Malta

Intermectin

Ivermectin 10 mg/ml

Bovine, ovine, caprine, porcine

Subcutanat

Bovine, ovine, caprine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Malta

Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland INDUSTRIAL VETERINARIA, S.A. C/ Esmeralda, 19 08950 Esplugues de Llobregat Barcelona Spain

Noromectin Multi Injection

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Malta

Promectine

Ivermectin 10 mg/ml

Bovine

Subcutanat

35/71

Stat membru rile de Jos

Titularul autorizaiei de introducere pe pia i adresa Merial B.V. Kleermakerstraat 10 1991 JL Velserbroek The Netherlands

Denumirea inventat Ivomec

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

rile de Jos

Merial B.V. Kleermakerstraat 10 1991 JL Velserbroek The Netherlands Merial B.V. Kleermakerstraat 10 1991 JL Velserbroek The Netherlands

Ivomec Plus

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

rile de Jos

Panomec Injectievloeistof

Bovine, ovine, porcine

Subcutanat

rile de Jos

Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland

Animec Injection

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

rile de Jos

Euromec Injectie

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

36/71

Stat membru rile de Jos

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland Laboratorios Calier SA Barcelones 26 (Pla del Ramassa) 08520 Les Franqueses del Valles Barcelona Spain Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland

Denumirea inventat Paramectin Injectie

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

rile de Jos

Noromectin Injectie

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

rile de Jos

Maximec Injectie

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

rile de Jos

Ivertin Cattle

Ivermectin 10 mg/ml

Bovine

Subcutanat

rile de Jos

Bimectin Injectie

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

37/71

Stat membru rile de Jos

Titularul autorizaiei de introducere pe pia i adresa VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands

Denumirea inventat Virbamec F

Concentra ii Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal

rile de Jos

Ges-o-mec 10mg/ml oplossing voor injectie

Bovine, ovine, porcine

Subcutanat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine, reni: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

rile de Jos

Qualimec 10mg/g solution for injection

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

rile de Jos

Iverveto 1%

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Norvegia

MERIAL 29 avenue Tony Garnier 69007 LYON France

Ivomec vet, injeksjonsvske, opplsning 10 mg/ml

Ivermectin 10 mg/ml

Bovine, ovine, reni, porcine

Subcutanat

38/71

Stat membru Norvegia

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal Vetoquinol Biowet Sp. z o.o., ul. Kosynierw Gdyskich 13-14, 66-400 Gorzw Wlkp., Poland

Denumirea inventat Noromectin Vet Injection

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Norvegia

VIRBAMEC VET

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Polonia

Biomectin 1%

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Polonia

Ceva Sante Animale La Ballastiere B.P. 126 33501 Libourne Cedex France

Cevamec 1%

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

39/71

Stat membru Polonia

Titularul autorizaiei de introducere pe pia i adresa Drwalewskie Zakady Przemysu Bioweterynaryjnego S.A. ul. Grjecka 6 05-651 Drwalew Poland Pharmaceutical Company PFO "VETOS-FARMA" sp. z.o.o., Dzierzoniwska street 21 58-260 Bielawa Poland Agri- Biovet Sp. z o.o. ul. Smocza 27 01-048 Warsaw Poland

Denumirea inventat Ivermina 1% Inj

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Polonia

Iwermektyna 1% Iniekcja

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Polonia

Pandex 1%

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Polonia

Scan Vet Poland Sp. z o.o. Skiereszewo, ul. Kiszkowska 9 62-200 Gniezno Poland

Paramectin 1%

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

40/71

Stat membru Polonia

Titularul autorizaiei de introducere pe pia i adresa Przedsibiorstwo Wielobranowe Vet Agro Sp. z o.o. ul. Gliniana 32 20-616 Lublin Poland Bimeda (a division of Cross Vetpharm Group Limited) Broomhill Road Tallaght Dublin 24 Ireland Calier Portugal S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. P de Mouro Estrada de Albarraque 2710 - 335 Sintra Portugal Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland

Denumirea inventat Vetamectin

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Portugalia

Tizoval Bovinos 1%

Ivermectin 10 mg/ml

Bovine

Subcutanat

Portugalia

Ivertin

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Portugalia

Chanectin Injectvel

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Portugalia

Maximec Injectvel para bovinos e ovinos 1%

Ivermectin 10 mg/ml

Bovine, ovine

Subcutanat

200 g ivermectin/kg greutate corporal

41/71

Stat membru Portugalia

Titularul autorizaiei de introducere pe pia i adresa ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Merial Portuguesa - Sade Animal, Lda AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas 2635-432 Rio de Mouro Portugal Merial Portuguesa - Sade Animal, Lda AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas 2635-432 Rio de Mouro Portugal

Denumirea inventat Ecomectin 1% Sol Injectvel

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal

Portugalia

Vectimax 10 mg/Ml Sol. Inj. Este

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Portugalia

Ivomec F

Ivermectin 10 mg/ml, clorsulon 100 mg/ml

Bovine

Subcutanat

Portugalia

Ivomec 1% Bovinos, Soluo Injectvel

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

42/71

Stat membru Portugalia

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland

Denumirea inventat Paramectin Injectvel 1%

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal

Portugalia

Noromectin Injectvel 1%

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Portugalia

Virbamec F, Soluo Injectvel 1mg/ml

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

Portugalia

VIRBAMEC, Soluo injectavel

Bovine, ovine, porcine

Subcutanat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Portugalia

Closamectin FF, soluo injectvel para bovinos

Ivermectin 5 mg/ml, closantel 125 mg/ml

Bovine

Subcutanat

43/71

Stat membru Romnia

Titularul autorizaiei de introducere pe pia i adresa ANTIBIOTICE IASI S.A. Str. Valea Lupului, nr. 1, Iai, jud. Iai Romania BIOWET GORZOW PHARMACEUTICALS COMPANY- Kosynierw Gdyskich 13/14 ST., Gorzow WLPK Poland BIOVET JSC 39 Petar Rakov Str. 4550 Pesthera Bulgaria Bioveta a.s., Komenskho 212 683 23 Ivanovice na Han Czech Republic Bremer Pharma GmbH Cherbourger Str. 25 27540 Bremerhaven Germany CEVA SANTE ANIMALE Str. Chindiei, nr. 5 Sector 4 040185 Bucureti Romania DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD. Jordan NA UR 11710 PO BOX 285 Jordania

Denumirea inventat Ivermectin 1%

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Romnia

Biomectin 1%

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Romnia

Pandex 1%

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Romnia

Biomec inj.

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Romnia

Bremamectin

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Romnia

Cevamec 1%

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Romnia

Ivodad 1%

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

44/71

Stat membru Romnia

Titularul autorizaiei de introducere pe pia i adresa DUTCH FARM VETERINARY PHARMACEUTICALS B.V. Veemweg 1-3771 MT BARNEVELEND The Netherlands ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom FARMAVET S.A. Str. Petricani 198, Chiinu Republica Moldova HEMOFARM HEMOVET Beogradski Put BB Vrsac Serbia Laboratorios HIPRA S.A. Avda. La Selva, 135 17170 Amer, Girona Spain Interchemie werken de Adelaar BV Horsterweg 26A 5811 AC Castenray The Netherlands INTERVET PRODUCTIONS SRL Via Nettunense km 20, 300 04011 Aprilia Italy

Denumirea inventat Dufamec 1% inj.

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Romnia

Ecomectin 1% injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Romnia

Ivermectin 1%

Ivermectin 10 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Romnia

Ivermektin S

Bovine

Subcutanat

Romnia

Iveripra I

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Romnia

Intermectin

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Romnia

Ivogell

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

45/71

Stat membru Romnia

Titularul autorizaiei de introducere pe pia i adresa INTERVET ROMANIA S.R.L. oseaua de Centur, nr. 27-28, 077040 Chiajna, Ilfov Romania MERIAL 29 avenue Tony Garnier 69007 LYON France PANTEX Ganzestaartsedijk 8 5525 KC Duizel The Netherlands PASTEUR Filiala Filipeti Str. Principal, nr. 944, Filipetii de Pdure, Jud. Prahova Romania S.C. ROMVAC COMPANY S.A. os. Centurii, nr. 7, Voluntari Romania SYVA Av. Prroco Pablo Diez, 49 57 24010 Leon Spain VMD Animal Health Ltd. Kzraktr u. 22/b. II. 3., 1093 Budapest Hungary

Denumirea inventat Ivotan LA

Concentra ii Ivermectin 10 mg/ml Ivermectin 10 mg/ml Ivermectin 10 mg/ml Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Romnia

Ivomec 1%

Bovine

Subcutanat

Romnia

Panmectin 10

Bovine

Subcutanat

Romnia

Evomec

Bovine

Subcutanat

Romnia

Romivermectin B1 1% Zoomectin

Ivermectin 10 mg/ml Ivermectin 10 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Romnia

Bovine

Subcutanat

Romnia

Iverveto 1% Injection

Bovine

Subcutanat

46/71

Stat membru Republica Slovac

Titularul autorizaiei de introducere pe pia i adresa Vtoquinol s.r.o., Zmencka 411, 288 02 Nymburk, Czech Republic

Denumirea inventat Biomectin

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine, caprine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Republica Slovac

CEVA Animal Health Slovakia, spol. s r.o. Raianska 77 83 102 BRATISLAVA Slovak Republic

Cevamec 1 % inj. ad us. vet.

Ivermectin 10 mg/ml

Bovine, ovine, caprine, porcine

Subcutanat

Republica Slovac

Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland MERIAL 29 avenue Tony Garnier 69007 LYON France

Noromectin Injection ad us vet

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Republica Slovac

Ivomec 1% inj. ad us.vet.

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Republica Slovac

MERIAL 29 avenue Tony Garnier 69007 LYON France

Ivomec Super inj. ad us.vet.

Ivermectin 10 mg/ml, clorsulon 100 mg/ml

Bovine, ovine

Subcutanat

47/71

Stat membru Republica Slovac

Titularul autorizaiei de introducere pe pia i adresa ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Pharmagal spol.s.r.o. Murgaova 5 949 01 Nitra Slovak Republic

Denumirea inventat Ecomectin

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Republica Slovac

Galmectin

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Republica Slovac

Slovenia

Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland VET4VET d.o.o. Gerbieva 50, 1000 Ljubljana Slovenia

Closamectin injekny roztok pre hovdzi dobytok

Ivermectin 5 mg/ml, closantel 125 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

Animec Injection

Bovine, ovine, porcine

Subcutanat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Slovenia

VETERINA Plus d.o.o.,Dunajska 51, 1000 Ljubljana, Slovenia

IVERKTIN 1% solution for injection

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

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Stat membru Slovenia

Titularul autorizaiei de introducere pe pia i adresa MERIAL 29 avenue Tony Garnier 69007 LYON France

Denumirea inventat IVOMEC solution for injection

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Spania

DIVASA FARMAVIC, S.A. Ctra. Sant Hipolit, km 71 08503 Gurb-Vic Barcelona Spain Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland

DIVAMECTIN 1% SOLUCION

Ivermectin 10 mg/ml

Bovine, ovine

Subcutanat

Spania

Noromectin 1% Solution Inyectable para Bovino y Porcino

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Spania

VIRBAMEC SOLUCIN INYECTABLE PARA BOVINOS TIZOVAL VACUNO INYECTABLE

Ivermectin 10 mg/ml

Bovine

Subcutanat

Spania

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

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Stat membru Spania

Titularul autorizaiei de introducere pe pia i adresa Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Laboratorios Calier SA Barcelones 26 (Pla del Ramassa) 08520 Les Franqueses del Valles Barcelona Spain INDUSTRIAL VETERINARIA, S.A. C/ Esmeralda, 19 08950 Esplugues de Llobregat Barcelona Spain Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom Laboratorios HIPRA S.A. Avda. La Selva, 135 17170 Amer, Girona Spain

Denumirea inventat CHANECTIN INYECTABLE

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal

Spania

Paramectin Inyectable

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Spania

IVERTIN BOVINO

Ivermectin 10 mg/ml

Bovine

Subcutanat

Spania

PROMECTINE

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Spania

SUMEX INYECTABLE BOVINO IVERIPRA-I

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Spania

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

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Stat membru Spania

Titularul autorizaiei de introducere pe pia i adresa ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Chemo Iberica Gran Va Carlos III, 98 7th floor. 08028 Barcelona, Spain MERIAL LABORATORIOS S.A Tarragona, 161-Locales D/E 08014 Barcelona Spain MERIAL LABORATORIOS S.A Tarragona, 161-Locales D/E 08014 Barcelona Spain Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland MERIAL 29 avenue Tony Garnier 69007 LYON France

Denumirea inventat

Concentra ii

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

ECOMECTIN 10 Ivermectin MG/ML SOLUCION 10 mg/ml INYECTABLE

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Spania

BOVECTIN

Ivermectin 10 mg/ml

Bovine

Subcutanat

Spania

Ivomec Inyectable Para Vacuno

Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal

Spania

Ivomec F Inyectable Para Vacuno Closamectin Solucion inyectable para bovino

Spania

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 5 mg/ml, closantel 125 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal 200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Bovine

Subcutanat

Suedia

Ivomec vet.

Bovine, reni, porcine

Subcutanat

Bovine, reni: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

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Stat membru Suedia

Titularul autorizaiei de introducere pe pia i adresa VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2 2080-104 Almeirim Portugal Bimeda (a division of Cross Vetpharm Group Limited) Broomhill Road Tallaght Dublin 24 Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom

Denumirea inventat Virbamec vet. 10 mg/ml injektionsvtska, lsning

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, reni, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, reni: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, reni: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, reni: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Suedia

Bimectin vet.

Ivermectin 10 mg/ml

Bovine, reni, porcine

Subcutanat

Suedia

Noromectin vet Solution for Injection 10mg/ml

Ivermectin 10 mg/ml

Bovine, reni, porcine

Subcutanat

Suedia

Ecomectin, 10 mg/ml, Injektionsvtska, lsning

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

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Stat membru Suedia

Titularul autorizaiei de introducere pe pia i adresa ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Laboratorios Calier SA Barcelones 26 (Pla del Ramassa) 08520 Les Franqueses del Valles Barcelona Spain Merial Animal Health Limited Sandringham House Harlow Business Park Harlow Essex CM19 5TG United Kingdom Merial Animal Health Limited Sandringham House Harlow Business Park Harlow Essex CM19 5TG United Kingdom Merial Animal Health Limited Sandringham House Harlow Business Park Harlow Essex CM19 5TG United Kingdom

Denumirea inventat Qualimec, 10 mg/ml, Injektionsvtska, lsning

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Regatul Unit

Ivertin Cattle

Ivermectin 10 mg/ml

Bovine

Subcutanat

Regatul Unit

Ivomec Classic Injection for Cattle and Sheep

Ivermectin 10 mg/ml

Bovine, ovine

Subcutanat

200 g ivermectin/kg greutate corporal

Regatul Unit

Ivomec Super Injection for Cattle

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal

Regatul Unit

Panomec Injection for Cattle, Sheep and Pigs

Bovine, ovine, porcine

Subcutanat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

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Stat membru Regatul Unit

Titularul autorizaiei de introducere pe pia i adresa Chanelle Animal Health Ltd 7 Rodney Street Liverpool L1 9HZ United Kingdom VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal VIRBAC DE PORTUGAL Laboratorios LdaRua Dionsio Saraiva, Lote 1, 1 Andar, Sala, 22080-104 Almeirim Portugal VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionsio Saraiva, Lote 1, 1 Andar, Sala 2, 2080-104 Almeirim Portugal Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland

Denumirea inventat Animec Injection

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 2 mg clorsulon/kg greutate corporal 200 g ivermectin/kg greutate corporal

Regatul Unit

Virbamec Injectable Solution For Cattle and Swine

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Regatul Unit

Virbamec Injectable Solution for Cattle, Swine and Sheep

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Regatul Unit

Virbamec Super

Ivermectin 10 mg/ml, clorsulon 100 mg/ml Ivermectin 10 mg/ml

Bovine

Subcutanat

Regatul Unit

Enovex Injection

Bovine

Subcutanat

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Stat membru Regatul Unit

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland Cross Vetpharm Group Ltd, Broomhill Road Tallaght Dublin 24 Ireland

Denumirea inventat Noromectin Multi Injection

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, ovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal

Regatul Unit

Paramectin Injection

Ivermectin 10 mg/ml

Bovine

Subcutanat

Regatul Unit

Paramectin Multi Injection 1% w/v Solution for Injection for Cattle, Sheep and Pigs Bimectin 1% w/v Solution for Injection

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal

Regatul Unit

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Regatul Unit

Ecomec 1% Injection

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

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Stat membru Regatul Unit

Titularul autorizaiei de introducere pe pia i adresa Cross Vetpharm Group Ltd, Broomhill RoadTallaghtDublin 24Ireland

Denumirea inventat Qualimintic 1% Injection

Concentra ii Ivermectin 10 mg/ml

Specii de animale Bovine, porcine

Calea de administrare Subcutanat

Doza recomandat

Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal Bovine, ovine: 200 g ivermectin/kg greutate corporal Porcine: 300 g ivermectin/kg greutate corporal 200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Regatul Unit

Alstoe Ltd Sheriff Hutton Industrial Park Sheriff Hutton York YO60 6RZ United Kingdom ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland

Alstomec

Ivermectin 10 mg/ml

Bovine, porcine

Subcutanat

Regatul Unit

Ecomectin 10 mg/ml Solution for Injection

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Regatul Unit

Qualimec 10 mg/ml Solution for Injection

Ivermectin 10 mg/ml

Bovine, ovine, porcine

Subcutanat

Regatul Unit

Closamectin Injection

Ivermectin 5 mg/ml, closantel 125 mg/ml

Bovine

Subcutanat

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Stat membru Regatul Unit

Titularul autorizaiei de introducere pe pia i adresa Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland Norbrook Laboratories Limited Station Works Camlough Road Newry BT35 6JP Country Down Northern Ireland

Denumirea inventat Closiver Injection

Concentra ii Ivermectin 5 mg/ml, closantel 125 mg/ml Ivermectin 5 mg/ml, closantel 125 mg/ml

Specii de animale Bovine

Calea de administrare Subcutanat

Doza recomandat

200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

Regatul Unit

Norofas Solution for Injection

Bovine

Subcutanat

200 g ivermectin/kg greutate corporal, 5 mg closantel/kg greutate corporal

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ANEXA II CONCLUZII TIINIFICE I MOTIVE PENTRU MODIFICAREA REZUMATULUI CARACTERISTICILOR PRODUSULUI, ETICHETRII I PROSPECTULUI

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REZUMATUL GENERAL AL EVALURII TIINIFICE A MEDICAMENTELOR INJECTABILE DE UZ VETERINAR CARE CONIN IVERMECTIN 1. Introducere
Ivermectina este un endectocid cu spectru larg din familia avermectinei. n cazul bovinelor, medicamentele injectabile de uz veterinar care conin ivermectin, fie ca ingredient activ unic, fie n combinaie cu o a doua substan activ, sunt folosite mpotriva infestrilor cu endoparazii i ectoparazii prin administrarea subcutanat a unei doze de 200 g ivermectin/kg greutate corporal. Ivermectina a fost evaluat anterior de ctre CVMP n vederea stabilirii limitelor maxime ale reziduurilor (LMR). O doz zilnic acceptabil (DZA) din punct de vedere toxicologic de 10 g/kg greutate corporal/zi (600 g/persoan pe zi) a fost stabilit pe baza unei doze fr efect observabil (no observed efect level, NOEL) de 0,5 mg/kg greutate corporal/zi prezentat ntr-un studiu de 14 sptmni la cini, aplicnd un factor de siguran de 50. Ivermectina este n prezent inclus n anexa I la Regulamentul (CEE) nr. 2377/90 al Consiliului cu LMR pentru toate speciile de la care se obin produse alimentare, dup cum urmeaz: Substan farmacologic activ Ivermectin Marker de reziduuri Specii de animale LMR esut int Alte dispoziii

22,23Toate speciile Dihidroavermectin de mamifere B1a de la care se obin produse alimentare

100 g/kg esut 100 g/kg adipos 30 g/kg Ficat Rinichi

A nu se folosi la animalele de la care se obine lapte pentru consum uman.

Pe baza acestor LMR, doza zilnic total de reziduuri va reprezenta aproximativ 15% din DZA. Autorizaiile de introducere pe pia pentru medicamente injectabile de uz veterinar care conin ivermectin i care sunt destinate bovinelor au fost acordate n toate statele membre ale Uniunii Europene prin diferite proceduri de autorizare (proceduri de recunoatere reciproc i proceduri naionale) i n temeiul unor baze juridice diferite (complet, generic, bibliografic, consimmnt n cunotin de cauz). Regatul Unit i-a exprimat preocuparea cu privire la faptul c decalajele ntre perioadele de ateptare stabilite pe teritoriul Uniunii Europene pentru produsele relevante pot prezenta un potenial risc pentru sntatea uman i a cerut Comitetului pentru produse medicamentoase de uz veterinar (CVMP) s emit un aviz referitor la acest aspect. Procedura a implicat 293 medicamente injectabile de uz veterinar autorizate care conin ivermectin (a se vedea anexa I).

2. Discutarea problemelor specifice indicate n sesizare


Din datele generale depuse de ctre titularii autorizaiilor de introducere pe pia i de autoritile naionale competente ale statelor membre, numai 11 studii privind reducerea reziduurilor de ivermectin au fost considerate ca avnd calitatea adecvat n scopul calculrii perioadelor de ateptare, deoarece numai n aceste studii au fost prelevate eantioanele i analizate esuturile relevante incluznd locurile de injectare. S-a constatat c anumite studii erau identice ns fuseser naintate de diferii titulari ai autorizaiilor de introducere pe pia. n toate cazurile n care fost posibil, CVMP a utilizat metoda statistic de calculare a perioadelor individuale de ateptare pe baza unor studii singulare, ns n conformitate cu Nota de orientare a CVMP: Abordare n vederea armonizrii perioadelor de ateptare (EMEA/CVMP/036/95)1, atunci
1

Nota de orientare a CVMP: Abordare n vederea armonizrii perioadelor de ateptare http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf


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cnd parametrii necesari nu au fost considerai valabili pentru analiza statistic, s-a utilizat abordarea alternativ pentru calcularea perioadelor de ateptare. Deoarece nu exist nici o LMR muscular pentru ivermectin, la evaluarea dozei totale zilnice de reziduuri care poate decurge din consumul de esuturi ale fiecrui animal, a fost utilizat abordarea n funcie de DZA (EMEA/CVMP/542/03-Final)2. Atunci cnd s-a utilizat abordarea alternativ pentru datele de studiu privind reziduurile individuale, perioada a fost determinat de la primul punct temporal la care toate dozele calculate erau mai mici dect DZA, adugndu-se un interval de siguran. A fost utilizat un interval de siguran de 30%, avnd n vedere marile diferene ntre cifrele referitoare la doze, lucru care a fost determinat n primul rnd de variaiile n reziduurile observate la locurile de injectare. Pe baza celor 11 studii privind reducerea reziduurilor de ivermectin, care au avut o calitate corespunztoare, CVMP a calculat perioadele de ateptare pentru 12 produse. Perioadele individuale de ateptare calculate de ctre CVMP au variat de la 21 de zile la 78 de zile. n plus, pentru un numr suplimentar de 11 produse pentru care au fost furnizate date referitoare la reducerea reziduurilor, s-a concluzionat c nu se pot calcula perioadele individuale de ateptare datorit caracterului inadecvat al datelor furnizate specifice produselor. O problem cheie ridicat de aceast sesizare se refer la existena sau inexistena unui efect al formulei asupra reducerii reziduurilor din esuturi i n special la locul de injectare. Pentru a aborda aceast chestiune, experii pe probleme de calitate au examinat compoziia calitativ i cantitativ a tuturor celor 293 de produse coninnd ivermectin care fac obiectul sesizrii, grupnd produsele care pot fi considerate a fi similare sau n esen similare. Astfel, au fost stabilite 13 grupe de formule. Fiecare grup coninea produse considerate a fi n esen similare, n ceea ce privete formula. Tabelul de mai jos conine lista celor 13 grupe de formule, mpreun cu numrul de produse din fiecare grup, numrul de studii disponibile pentru fiecare grup i perioadele individuale de ateptare calculate pentru diferite produse pentru care s-au pus la dispoziie date adecvate. Numerotarea grupelor de formule este arbitrar. Tabelul 1. Grupe de formule alocate pentru cele 293 de produse care fac obiectul acestei sesizri. Grupa de formule 1 2 3 4 5 6 7 8 9 10 11 12 13
2

Numr de produse 108 45 18 58 3 22 1 1 2 19 13 2 1

Numr de studii Perioade individuale (zile) de acceptabile privind ateptare conform studiilor privind reducerea reziduurilor reziduurile de ivermectin 5 21, 23, 37, 47, >49 1 1 1 Nu exist date adecvate 1 Nu exist date adecvate Nu exist date adecvate Nu exist date adecvate 1 1 Nu exist date adecvate Nu exist date adecvate 46 42 29 78 55 29

Orientare CVMP privind reziduurile la locul injectrii. http://www.emea.europa.eu/pdfs/vet/swp/054203en.pdf

Publicaie disponibil pe site-ul web al EMEA,

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Din tabelul 1 de mai sus reiese n mod evident c din grupa 1, pentru care au fost disponibile mai multe studii, perioadele de ateptare calculate au variat n mod considerabil (de la 21 la >49 de zile). Variabilitatea perioadelor de ateptare calculate reflect variabilitatea profilurilor de reducere i, n special, variabilitatea reducerii reziduurilor la locul injectrii. Trebuie menionat c, n cazul mai multor studii, datele au fost att de dispersate nct metoda statistic armonizat de stabilire a perioadelor de ateptare nu a putut fi utilizat, iar perioada de ateptare care rezult n urma utilizrii metodei alternative depinde ntotdeauna foarte mult de opiunea privind punctele temporale disponibile. S-a ncercat gsirea unei corelaii ntre pantele sau segmentele curbelor de reducere i oricare dintre urmtorii parametri: grup de formul, greutate corporal, ras, sex, vrst i volumul injeciei, utiliznd metodologia ANOVA sau Pearson. Din datele disponibile nu au reieit corelaii care s poat explica diferena ntre profilurile de reducere sau perioadele estimate de ateptare i niciunul dintre parametrii nregistrai nu a putut fi identificat ca o surs unic major a variaiei. Dei sursele exacte de variaie rmn neidentificate, este foarte probabil ca procedura de eantionare s fie unul dintre factorii importani; este dificil s se stabileasc n mod cert c zona cu cea mai mare concentraie de reziduuri este eantionat n mod corespunztor, n special n ceea ce privete injeciile subcutanate. Nivelul ridicat al variaiei n ceea ce privete concentraiile de reziduuri i profilurile de reducere observate att n interiorul, ct i ntre grupele de formule pot s fi mascat cu uurin un efect al formulei. n ansamblu, din datele examinate, prezena unui efect determinat de formul nu poate fi nici confirmat, nici respins. Alte surse ale variaiei legate de utilizarea subcutanat a ivermectinei au fost, prin urmare, considerate a avea mai mult importan dect formula, n ceea ce privete reducerea reziduurilor i perioadele de ateptare. Cu toate acestea, datele din literatura de specialitate indic faptul c formula poate avea un efect asupra ratei de absorbie a avermectinelor la locul injectrii. Un astfel de efect a fost demonstrat n cadrul studiilor experimentale efectuate de mai multe grupuri diferite (Lo et al., 19853; Wicks et al., 19934; Lifschitz et al. 19995, Lifschitz et al., 20046). n aceste studii, diferite formule au prezentat diferite modele de absorbie ale avermectinelor (inclusiv ivermectina), n timp ce toi ceilali parametri erau aceiai (de exemplu specia, rasa, greutatea i locul de injectare). Aceste observaii vin n sprijinul opiniei c n studiile furnizate CVMP, au fost prezente surse de variaie care erau mai importante dect efectele formulei. Ca principiu n ceea ce privete produsele despre care s-a demonstrat c sunt bioechivalente, trebuie menionat c definiia bioechivalenei nu garanteaz niveluri egale de reziduuri la locul de injectare cu mult peste punctele temporale n care au fost prelevate eantioanele de plasm. n realitate, o diferen mic i nesemnificativ din punct de vedere farmacologic n fraciunea absorbit (de exemplu, 99,5% fa de 99,9%) la un anumit punct temporal poate implica o diferen semnificativ n ceea ce privete cantitatea rmas la locul injectrii (un factor de 5 n acest exemplu). Deoarece echivalena nivelurilor locale de reziduuri la locul injectrii nu poate fi estimat pe baza bioechivalenei plasmei i deoarece datele publicate indic faptul c formula poate avea un impact asupra profilurilor de reducere a reziduurilor pentru ivermectin, CVMP consider c, n general, nu exist nicio baz pentru extrapolarea automat a unei perioade de ateptare stabilite pentru o formul la o a doua formul, chiar dac s-a demonstrat bioechivalena n plasm. Pe de alt parte, nu exist niciun raionament tiinific care s explice de ce perioadele de ateptare pentru formulele care sunt similare sau n esen similare trebuie s fie diferite. Dei datele examinate
3

Lo, P-K.A., Fink, D.W., Williams, J.B., Blondinger, J. (1985) Pharmacokinetic studies of ivermectin: effects of formulation. Vet. Res. Comm. 9: 251-268 Wicks, S.R., Kaye, B., Weatherley, A.J., Lewis, D., Davison, E., Gibson, S.P., Smith, D.G. (1993) Effect of formulation on the pharmacokinetics and efficacy of doramectin Vet. Parasitol. 49: 17-26

Lifschitz, A., Virkel, G. Pis, A., Imperiale, F., Sanchez, S., Alvarez, L., Kujanek, R, Lanusse, C. (1999) Ivermectin disposition kinetics after subcutaneous and intramuscular administration of an oil-based formulation to cattle. Vet. Parasitol. 86: 203-215

6 Lifschitz, A., Sallovitz, J., Imperiale, F., Pis, A., Jauregui Lorda, J., Lanusse, C. (2004) Pharmacokinetic evaluation of four ivermectin generic formulations in calves. Vet. Parasitol. 119: 247-257

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de ctre CVMP au condus la calcularea unor perioade de ateptare diferite pentru produse care sunt n esen similare, nu se consider c aceast variabilitate reflect efecte specifice produsului, ci este mai degrab o caracteristic a modului n care produsele au fost utilizare (respectiv variaia este rezultatul unor diferene precum greutatea corporal a animalelor, rasa, sexul, vrsta, volumul injeciei i procedura de eantionare). CVMP consider c produsele care sunt n esen similare (n ceea ce privete formula) trebuie s aib perioade de ateptare identice. n sensul acestei sesizri, acest lucru nseamn c perioadele de ateptare pentru toate produsele dintr-o singur grup de formule trebuie s fie similare. De asemenea, deoarece variaia profilului de reziduuri datorat unor surse de variaie asociate utilizrii subcutanate a ivermectinei este mult mai mare dect efectul formulei, Comitetul a ajuns la concluzia c ar fi adecvat s se considere c toate datele privind reziduurile de ivermectin din toate grupele de formule conduc la o singur perioad de ateptare armonizat. 2.1 Calcularea unei perioade armonizate de ateptare pentru produsele injectabile care conin ivermectin destinate bovinelor n figura de mai jos sunt reprezentate toate datele disponibile referitoare la dozele totale de reziduuri de ivermectin, n comparaie cu DZA.

all intake data for ivermectin


12 10 8 ln_intake 6 4 2 0 -2 0 -4 time (days)
Figura 1. Pe o scar logaritmic, doza total de reziduuri de ivermectin (g) pentru un consumator, calculat pornind de la datele referitoare la fiecare animal (puncte de date), n comparaie cu DZA (g/persoan, linie orizontal). Nu a fost posibil utilizarea metodei statistice pentru analiza acestor date cumulate, deoarece nu au fost ndeplinite o serie de ipoteze statistice relevante. Cu toate acestea, Comitetul a considerat c utilizarea abordrii alternative (primul punct temporal sub DZA plus intervalul de siguran) ar lua n considerare n mod insuficient cantitatea substanial de date (280 de puncte de date) disponibile n acest caz specific. Comitetul a considerat c pe baza totalitii datelor i pe baza faptului c n ziua a 49-a i dup aceast zi calculul dozei rmne peste DZA pentru numai dou animale, o perioad de ateptare de 49 de zile ar oferi un grad de siguran comparabil cu cel oferit de utilizarea abordrii statistice (i o perioad de ateptare pe baza unei limite de toleran de 95%). Prin urmare, Comitetul a ajuns la concluzia c perioada de ateptare armonizat de 49 de zile poate fi stabilit pentru componenta ivermectin din toate produsele injectabile care conin ivermectin, destinat utilizrii n cazul bovinelor.

5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

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2.2

Stabilirea perioadei de ateptare pentru medicamentele injectabile de uz veterinar care conin ivermectin, precum i o a doua substan activ (produse combinate)

Perioada de ateptare armonizat de 49 de zile este relevant doar pentru componenta ivermectin a produselor injectabile care conin ivermectin. Pentru medicamentele injectabile de uz veterinar care conin ivermectin n combinaie cu o alt substan activ, trebuie avut n vedere, de asemenea, reducerea reziduurilor celei de-a doua substane active i trebuie s se calculeze o perioad de ateptare pentru cea de-a doua substan activ. Perioada de ateptare a produsului va fi cea mai lung dintre perioadele de ateptare stabilite pentru componentele individuale. Dac perioada de ateptare determinat pe baza datelor privind reducerea reziduurilor pentru cea de-a doua substan activ este mai mic de 49 de zile, atunci se recomand o perioad de ateptare de 49 de zile pentru produs. Pe de alt parte, dac perioada de ateptare determinat pe baza datelor privind reducerea reziduurilor pentru cea de-a doua substan activ este mai mare de 49 de zile, atunci perioada de ateptare recomandat pentru produs trebuie s se bazeze pe reducerea reziduurilor celei de-a doua substane active. Prin urmare, o perioad de ateptare de minim 49 de zile se va aplica n toate cazurile pentru produsele combinate. Dintre grupele de formule n care au fost alocate produsele n cadrul acestei proceduri, dou includeau produse combinate: una cu produse ce conineau substanele active ivermectin i clorsulon i cea dea doua cu produse ce conineau substanele active ivermectin i closantel. Toate produsele care conineau ivermectin i clorsulon aveau formule similare i un numr de studii privind reducerea reziduurilor au fost naintate pentru componenta clorsulon a produselor din aceast grup. Studiile au fost bine realizate i au inclus un numr considerabil de puncte temporale de sacrificare. Avnd n vedere totalitatea datelor privind reducerea reziduurilor de clorsulon, nu a fost posibil utilizarea metodei statistice pentru calcularea perioadelor de ateptare ntruct nu au fost ndeplinite ipotezele statistice relevante. Lund n considerare datele privind reziduurile din cadrul studiilor, primul punct temporal la care niciuna din valori nu a depit nivelul maxim de reziduuri (NMR) pentru clorsulon a fost la 60 de zile. Utiliznd abordarea alternativ i aplicnd intervalul de siguran de 10%, a fost stabilit o perioad de ateptare de 66 de zile. Un interval de siguran de 10% a fost considerat adecvat deoarece studiile au fost ample i solide. Deoarece perioada de ateptare calculat pe baza componentei clorsulon pentru aceste produse depete perioada de 49 de zile stabilit pentru componenta ivermectin, se recomand 66 de zile ca perioad de ateptare pentru produsele combinate care conin ivermectin i clorsulon. Datele privind reducerea reziduurilor prezentate pentru grupa de formule care conin ivermectin i closantel au determinat o perioad de ateptare de 36 de zile pentru closantel, calculat utilizndu-se metoda alternativ i aplicndu-se un interval de siguran de 30%. ntruct aceast perioad este mai mic dect limita de 49 de zile aplicat pentru componenta ivermectin, se recomand o perioad de ateptare de 49 de zile pentru produsele combinate care conin ivermectin i closantel.

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MOTIVE PENTRU MODIFICAREA REZUMATULUI CARACTERISTICILOR PRODUSULUI


ntruct: CVMP a evaluat datele originale furnizate n cadrul acestei sesizri i a ajuns la concluzia c, pe baza acestor date, nu se poate demonstra un impact al formulei asupra reducerii reziduurilor i c variabilitatea datelor a fost de aa natur nct efectul formulei asupra reducerii reziduurilor ar fi putut fi mascat; CVMP a considerat c exist surse de variaie asociate utilizrii subcutanate a ivermectinei la bovine care conduc la diferite profiluri de reducere n cadrul studiilor privind reziduurile, iar aceast variaie este mult mai important dect orice variaie determinat de diferene ale formulei. Se ateapt ca aceste diferene s se produc i n practic; CVMP a considerat c, lund n considerare variaia ridicat observat, trebuie stabilit o singur perioad de ateptare armonizat pe baza tuturor datelor disponibile privind dozele de reziduuri pentru toate produsele vizate care conin ivermectin ca unic substan activ; CVMP a considerat c pentru produsele combinate care conin ivermectin, precum i o a doua substan activ, reducerea reziduurile celei de-a doua substane active trebuie, de asemenea, avut n vedere la stabilirea perioadei de ateptare, iar perioada de ateptare a produsului va fi cea mai lung dintre perioadele determinate pentru componentele individuale.

CVMP a recomandat modificarea autorizaiilor de introducere pe pia pentru toate medicamentele injectabile de uz veterinar care conin ivermectin, destinate utilizrii la bovine, aa cum se menioneaz n Anexa I, pentru care Rezumatul caracteristicilor produsului, etichetarea i prospectul sunt prezentate n Anexa III.

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ANEXA III MODIFICAREA REZUMATULUI CARACTERISTICILOR PRODUSULUI, ETICHETRII I PROSPECTULUI

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MODIFICRI CARE TREBUIE INCLUSE LA PUNCTELE RELEVANTE ALE REZUMATULUI CARACTERISTICILOR PRODUSULUI

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A. Pentru produsele enumerate n Anexa I care conin ivermectin i clorsulon ca ingrediente active: 4.11 Perioada (perioadele) de ateptare Bovine: carne i organe comestibile 66 de zile. B. Pentru produsele enumerate n Anexa I care conin ivermectin ca unic ingredient activ sau n combinaie cu closantel: 4.11 Perioada (perioadele) de ateptare Bovine: carne i organe comestibile - 49 de zile.

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MODIFICRI CARE TREBUIE INCLUSE LA PUNCTELE RELEVANTE ALE ETICHETRII

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A. Pentru produsele enumerate n Anexa I care conin ivermectin i clorsulon ca ingrediente active:

8.

PERIOADA DE ATEPTARE

Bovine: carne i organe comestibile 66 de zile. B. Pentru produsele enumerate n Anexa I care conin ivermectin ca unic ingredient activ sau n combinaie cu closantel:

8.

PERIOADA DE ATEPTARE

Bovine: carne i organe comestibile 49 de zile.

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MODIFICRI CARE TREBUIE INCLUSE LA PUNCTELE RELEVANTE ALE PROSPECTULUI

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A. Pentru produsele enumerate n Anexa I care conin ivermectin i clorsulon ca ingrediente active: 10. PERIOADA DE ATEPTARE

Bovine: carne i organe comestibile 66 de zile. B. Pentru produsele enumerate n Anexa I care conin ivermectin ca unic ingredient activ sau n combinaie cu closantel: 10. PERIOADA DE ATEPTARE

Bovine: carne i organe comestibile 49 de zile

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