Not the law itself: Notice

Address https://gelex.eu/eli/EU/notice/oj/C/2012/190/02@2012-06-29/en

Contents

1. Preamble
2. ANNEX
3. ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
4. ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
5. ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
6. ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT IN THE MEMBER STATES
7. ANNEX V LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT IN THE MEMBER STATES

Issuing, maintenance or modification of a national marketing authorization Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 7.5.2012 Vivaglobin and associated names See Annex I See Annex I 8.5.2012 22.5.2012 Femara and associated names See Annex II See Annex II 23.5.2012 25.5.2012 Priorix and associated names See Annex III See Annex III 30.5.2012 25.5.2012 Prontax 5 Mg/ml See Annex IV See Annex IV 30.5.2012 25.5.2012 Prontax 10 Mg/ml See Annex V See Annex V 29.5.2012

ANNEX

Anx_i_list_of_the_names_pharmaceutical_form_strengths_of_the_medicinal_products_route_of_administration_marketing_authorisation_holders_in_the_member. states. Member State EU/EEA Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Austria CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg an der Lahn Germany Vivaglobin 160 mg/ml Injektionslösung (subkutane Anwendung) 160 mg/ml solution for injection subcutaneous use Belgium CSL Behring GMBH Emil-von-Behring-Str. 76 35041 Marburg Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Denmark CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Finland CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use France CSL BEHRING SA - PARIS 44 rue Cambronne 75015 Paris, France Vivaglobin 160 mg/ml solution for injection subcutaneous use Germany CSL Behring GmbH, Emil von Behring Strasse 76, 35041 Marburg Vivaglobin Solution for infusion, 160 mg/ml solution for infusion subcutaneous use Greece CSL BEHRING ΜΕΠΕ XATZHGIANNI MEKSI 5 ATHENS 11528 VIVAGLOBIN 16 % (W/V) [150-170 MG] solution for injection subcutaneous use Hungary CSL Behring GmbH Emil-von-Behring-str. 76. 35041 Marburg Germany Vivaglobin 160 mg/ml oldatos injekció szubkután alkalmazásra 160 mg/ml solution for injection (subcutaneous use) solution for injection subcutaneous use Italy CSL BEHRING GmbH Emil von Behring Str 76 D-35041 Marburg-Germany VIVAGLOBIN 160 MG/ML solution for injection subcutaneous use Luxembourg CSL BEHRING GMBH 76 EMIL-VON-BEHRING-STRASSED 35041 MARBURG Vivaglobin 160 mg/ml solution for injection subcutaneous use The Netherlands CSL Behring GmbH, Emil v. Behring Str. 76, 35041 Marburg, Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Norway CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Poland CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Portugal CSL Behring GmbH Emil-von-Behring Strasse, 76 D-35041 Marburg Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Spain CSL BEHRING, GMBH Emil von Bhering Strasse, 76 35041 Marburg, Germany VIVAGLOBIN 160 mg/ml para inyección (uso subcutáneo) 160 mg/ml solution for injection subcutaneous use Sweden CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg, Tyskland Vivaglobin 160 mg/ml solution for injection subcutaneous use

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Austria CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg an der Lahn Germany Vivaglobin 160 mg/ml Injektionslösung (subkutane Anwendung) 160 mg/ml solution for injection subcutaneous use Belgium CSL Behring GMBH Emil-von-Behring-Str. 76 35041 Marburg Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Denmark CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Finland CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use France CSL BEHRING SA - PARIS 44 rue Cambronne 75015 Paris, France Vivaglobin 160 mg/ml solution for injection subcutaneous use Germany CSL Behring GmbH, Emil von Behring Strasse 76, 35041 Marburg Vivaglobin Solution for infusion, 160 mg/ml solution for infusion subcutaneous use Greece CSL BEHRING ΜΕΠΕ XATZHGIANNI MEKSI 5 ATHENS 11528 VIVAGLOBIN 16 % (W/V) [150-170 MG] solution for injection subcutaneous use Hungary CSL Behring GmbH Emil-von-Behring-str. 76. 35041 Marburg Germany Vivaglobin 160 mg/ml oldatos injekció szubkután alkalmazásra 160 mg/ml solution for injection (subcutaneous use) solution for injection subcutaneous use Italy CSL BEHRING GmbH Emil von Behring Str 76 D-35041 Marburg-Germany VIVAGLOBIN 160 MG/ML solution for injection subcutaneous use Luxembourg CSL BEHRING GMBH 76 EMIL-VON-BEHRING-STRASSED 35041 MARBURG Vivaglobin 160 mg/ml solution for injection subcutaneous use The Netherlands CSL Behring GmbH, Emil v. Behring Str. 76, 35041 Marburg, Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Norway CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Poland CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Portugal CSL Behring GmbH Emil-von-Behring Strasse, 76 D-35041 Marburg Germany Vivaglobin 160 mg/ml solution for injection subcutaneous use Spain CSL BEHRING, GMBH Emil von Bhering Strasse, 76 35041 Marburg, Germany VIVAGLOBIN 160 mg/ml para inyección (uso subcutáneo) 160 mg/ml solution for injection subcutaneous use Sweden CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg, Tyskland Vivaglobin 160 mg/ml solution for injection subcutaneous use

Anx_ii_list_of_the_names_pharmaceutical_form_strength_of_the_medicinal_products_route_of_administration_marketing_authorisation_holders_in_the_member. states. Member State EU/EEA Marketing authorisation holder Invented Name Strength Pharmaceutical form Route of administration Austria Novartis Pharma GmbH Stella-Klein Loew-Weg 17 1020 Vienna Austria Femara 2,5 mg – Filmtabletten 2,5 mg film-coated tablet Oral Belgium Novartis Pharma N.V. Medialaan, 40 bus 1, 1800 Vilvoorde Belgium Femara 2,5 mg film-coated tablet Oral Bulgaria Novartis Pharma GmbH Roonstrasse 25 90429 Nuernberg Germany Femara 2,5 mg film-coated tablet Oral Cyprus Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom Femara 2,5 mg film-coated tablet Oral Czech Republic Novartis s.r.o., Gemini, budova B Na Pankráci 1724/129 140 00 Prague 4 Czech Republic Femara 2,5 mg film-coated tablet Oral Denmark Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø Denmark Femar 2,5 mg film-coated tablet Oral Estonia Novartis Finland Oy Metsänneidonkuja 10 02130 Espoo Finland Femara 2,5 mg film-coated tablet Oral Finland Novartis Finland Oy Metsänneidonkuja 10 02130 Espoo Finland Femar 2,5 mg film-coated tablet Oral France Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex France Fémara 2,5 mg comprimé pelliculé 2,5 mg film-coated tablet Oral Germany Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg Germany Femara 2,5 mg Filmtabletten 2,5 mg film-coated tablet Oral Greece Novartis (Hellas) S.A.C.I. 12 km of National Road Athens, Lamia No 1, 14451 Metamorphosis, Athens Greece FEMARA 2,5 mg film-coated tablet Oral Hungary Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43-47 Hungary Femara 2,5 mg filmtabletta 2,5 mg film-coated tablet Oral Iceland Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø Denmark Femar 2,5 mg film-coated tablet Oral Ireland Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom Femara 2,5 mg Film-coated Tablets 2,5 mg film-coated tablet Oral Italy Novartis Europharm Ltd Wimblehurst Road RH12 5 Ab - Horsham (West Sussex) United Kingdom Femara 2,5 mg film-coated tablet Oral Latvia Novartis Finland Oy Metsänneidonkuja 10, 02130 Espoo Finland Femara 2,5 mg apvalkotās tabletes 2,5 mg film-coated tablet Oral Lithuania Novartis Finland Oy Metsänneidonkuja 10, 02130 Espoo Finland Femara 2,5 mg film-coated tablet Oral Luxembourg Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg, Germany Femara 2,5 mg film-coated tablet Oral Malta Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom Femara 2,5 mg film-coated tablet Oral Netherlands Novartis Pharma B.V. Raapopseweg 1, 6824 DP Arnhem The Netherlands Femara 2,5 mg film-coated tablet Oral Norway Novartis Norge AS Postboks 4284 Nydalen, 0401 Oslo Norway Femar 2,5 mg film-coated tablet Oral Poland Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg, Germany Femara 2,5 mg film-coated tablet Oral Portugal Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edif. 8, Quinta da Beloura 2710-444 Sintra Portugal Femara 2,5 mg film-coated tablet Oral Romania Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg, Germany Femara 2,5 mg comprimate filmate 2,5 mg film-coated tablet Oral Slovak Republic Novartis, s.r.o. Gemini, budova B Na Pankráci 1724,/129 14000 Prague 4, Czech Republic Femara 2,5 mg film-coated tablet Oral Slovenia Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg, Germany Femara 2,5 mg filmsko obložene tablete 2,5 mg film-coated tablet Oral Spain Laboratorios Padró, S.A. Gran Via de les Corts Catalanes, No 764 08013 Barcelona Spain Loxifan 2,5 mg comprimidos recubiertos con película 2,5 mg film-coated tablet Oral Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, No 764 08013 Barcelona Spain Femara 2,5 mg comprimidos recubiertos con película 2,5 mg film-coated tablet Oral Sweden Novartis Sverige AB Kemistvägen 1B, Box 1150, 18311 Täby, Sweden Femar 2,5 mg film-coated tablet Oral United Kingdom Novartis Pharmaceuticals UK Limited Trading as Ciba Laboratories Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom Femara 2,5 mg Tablets 2,5 mg film-coated tablet Oral

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA Marketing authorisation holder Invented Name Strength Pharmaceutical form Route of administration Austria Novartis Pharma GmbH Stella-Klein Loew-Weg 17 1020 Vienna Austria Femara 2,5 mg – Filmtabletten 2,5 mg film-coated tablet Oral Belgium Novartis Pharma N.V. Medialaan, 40 bus 1, 1800 Vilvoorde Belgium Femara 2,5 mg film-coated tablet Oral Bulgaria Novartis Pharma GmbH Roonstrasse 25 90429 Nuernberg Germany Femara 2,5 mg film-coated tablet Oral Cyprus Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom Femara 2,5 mg film-coated tablet Oral Czech Republic Novartis s.r.o., Gemini, budova B Na Pankráci 1724/129 140 00 Prague 4 Czech Republic Femara 2,5 mg film-coated tablet Oral Denmark Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø Denmark Femar 2,5 mg film-coated tablet Oral Estonia Novartis Finland Oy Metsänneidonkuja 10 02130 Espoo Finland Femara 2,5 mg film-coated tablet Oral Finland Novartis Finland Oy Metsänneidonkuja 10 02130 Espoo Finland Femar 2,5 mg film-coated tablet Oral France Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex France Fémara 2,5 mg comprimé pelliculé 2,5 mg film-coated tablet Oral Germany Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg Germany Femara 2,5 mg Filmtabletten 2,5 mg film-coated tablet Oral Greece Novartis (Hellas) S.A.C.I. 12 km of National Road Athens, Lamia No 1, 14451 Metamorphosis, Athens Greece FEMARA 2,5 mg film-coated tablet Oral Hungary Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43-47 Hungary Femara 2,5 mg filmtabletta 2,5 mg film-coated tablet Oral Iceland Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø Denmark Femar 2,5 mg film-coated tablet Oral Ireland Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom Femara 2,5 mg Film-coated Tablets 2,5 mg film-coated tablet Oral Italy Novartis Europharm Ltd Wimblehurst Road RH12 5 Ab - Horsham (West Sussex) United Kingdom Femara 2,5 mg film-coated tablet Oral Latvia Novartis Finland Oy Metsänneidonkuja 10, 02130 Espoo Finland Femara 2,5 mg apvalkotās tabletes 2,5 mg film-coated tablet Oral Lithuania Novartis Finland Oy Metsänneidonkuja 10, 02130 Espoo Finland Femara 2,5 mg film-coated tablet Oral Luxembourg Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg, Germany Femara 2,5 mg film-coated tablet Oral Malta Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom Femara 2,5 mg film-coated tablet Oral Netherlands Novartis Pharma B.V. Raapopseweg 1, 6824 DP Arnhem The Netherlands Femara 2,5 mg film-coated tablet Oral Norway Novartis Norge AS Postboks 4284 Nydalen, 0401 Oslo Norway Femar 2,5 mg film-coated tablet Oral Poland Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg, Germany Femara 2,5 mg film-coated tablet Oral Portugal Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edif. 8, Quinta da Beloura 2710-444 Sintra Portugal Femara 2,5 mg film-coated tablet Oral Romania Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg, Germany Femara 2,5 mg comprimate filmate 2,5 mg film-coated tablet Oral Slovak Republic Novartis, s.r.o. Gemini, budova B Na Pankráci 1724,/129 14000 Prague 4, Czech Republic Femara 2,5 mg film-coated tablet Oral Slovenia Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg, Germany Femara 2,5 mg filmsko obložene tablete 2,5 mg film-coated tablet Oral Spain Laboratorios Padró, S.A. Gran Via de les Corts Catalanes, No 764 08013 Barcelona Spain Loxifan 2,5 mg comprimidos recubiertos con película 2,5 mg film-coated tablet Oral Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, No 764 08013 Barcelona Spain Femara 2,5 mg comprimidos recubiertos con película 2,5 mg film-coated tablet Oral Sweden Novartis Sverige AB Kemistvägen 1B, Box 1150, 18311 Täby, Sweden Femar 2,5 mg film-coated tablet Oral United Kingdom Novartis Pharmaceuticals UK Limited Trading as Ciba Laboratories Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom Femara 2,5 mg Tablets 2,5 mg film-coated tablet Oral

Anx_iii_list_of_the_names_pharmaceutical_forms_strength_of_the_medicinal_products_routes_of_administration_marketing_authorisation_holders_in_the_member. states. Member State EU/EEA Marketing authorisation holder (Invented) Name Strength Pharmaceutical form Route of administration Austria GlaxoSmithKline Pharma GmbH Albert Schweitzer-Gasse 6 A-1140 Wien Austria Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Austria GlaxoSmithKline Pharma GmbH Albert Schweitzer-Gasse 6 A-1140 Wien Austria Priorix Powder in vials and solvent in prefilled-syringes for solution for injection Subcutaneous use Intramuscular use Belgium GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Bulgaria GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for suspension for injection Subcutaneous use Intramuscular use Cyprus GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Czech Republic GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Denmark GlaxoSmithKline Pharma A/S Nykær 68 DK-2605 Brøndby Denmark Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Estonia GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Finland GlaxoSmithKline Biologicals SA Rue de l’Institut 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use France Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi Cedex France Priorix powder and solvent for solution for injection in a pre-filled syringe Measles, mumps, and rubella vaccine (live) Powder and solvent for solution for injection Subcutaneous use Germany GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München Germany Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Greece GlaxoSmithKline AEBE 266 Kifisias avenue 152 32 Halandri Greece Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Hungary GlaxoSmithKline Kft. 1124 Budapest Csörsz u 43 Hungary Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Iceland GlaxoSmithKline ehf. Thverholt 14 105 Reykjavik Iceland Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Ireland GlaxoSmithKline (Ireland) Limited Stonemasons Way Rathfarnham Dublin 16 Ireland Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Italy GlaxoSmithKline S.p.A. Via A. Fleming, 2 37135 Verona Italy Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Latvia GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix pulveris un šķīdinātājs injekciju šķīduma pagatavošanai Powder and solvent for solution for injection Subcutaneous use Intramuscular use Lithuania UAB GlaxoSmithKline Lietuva Goštauto 40A LT-01112, Vilnius Lithuania Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Luxembourg GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Malta SmithKline Beecham plc Great West Road, Brentford, Middlesex TW8 9GS Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT United Kingdom Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Netherlands GlaxoSmithKline BV Huis ter Heideweg 62 3705 LZ Zeist The Netherlands Priorix Powder and solvent for solution for injection Subcutaneous use Norway GlaxoSmithKline AS Forskningsveien 2a Postboks 180 Vinderen 0319 Oslo Norway Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Poland GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Portugal Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda. Rua Dr. António Loureiro Borges, 3 Arquiparque – Miraflores 1495-131 Algés Portugal Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Romania GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Slovak Republic GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Slovenia GSK d.o.o., Ljubljana, Knezov štradon 90, 1000 Ljubljana Slovenia Priorix prašek in vehikel za raztopino za injiciranje Powder and solvent for solution for injection Subcutaneous use Intramuscular use Spain GlaxoSmithKline, S.A. C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) Spain Priorix polvo y disolvente en jeringa precargada para solución inyectable Powder and solvent for solution for injection Subcutaneous use Intramuscular use Sweden GlaxoSmithKline AB, Box 516, 169 29 Solna Sweden Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use United Kingdom SmithKline Beecham plc 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT United Kingdom Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA Marketing authorisation holder (Invented) Name Strength Pharmaceutical form Route of administration Austria GlaxoSmithKline Pharma GmbH Albert Schweitzer-Gasse 6 A-1140 Wien Austria Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Austria GlaxoSmithKline Pharma GmbH Albert Schweitzer-Gasse 6 A-1140 Wien Austria Priorix Powder in vials and solvent in prefilled-syringes for solution for injection Subcutaneous use Intramuscular use Belgium GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Bulgaria GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for suspension for injection Subcutaneous use Intramuscular use Cyprus GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Czech Republic GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Denmark GlaxoSmithKline Pharma A/S Nykær 68 DK-2605 Brøndby Denmark Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Estonia GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Finland GlaxoSmithKline Biologicals SA Rue de l’Institut 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use France Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi Cedex France Priorix powder and solvent for solution for injection in a pre-filled syringe Measles, mumps, and rubella vaccine (live) Powder and solvent for solution for injection Subcutaneous use Germany GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München Germany Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Greece GlaxoSmithKline AEBE 266 Kifisias avenue 152 32 Halandri Greece Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Hungary GlaxoSmithKline Kft. 1124 Budapest Csörsz u 43 Hungary Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Iceland GlaxoSmithKline ehf. Thverholt 14 105 Reykjavik Iceland Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Ireland GlaxoSmithKline (Ireland) Limited Stonemasons Way Rathfarnham Dublin 16 Ireland Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Italy GlaxoSmithKline S.p.A. Via A. Fleming, 2 37135 Verona Italy Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Latvia GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix pulveris un šķīdinātājs injekciju šķīduma pagatavošanai Powder and solvent for solution for injection Subcutaneous use Intramuscular use Lithuania UAB GlaxoSmithKline Lietuva Goštauto 40A LT-01112, Vilnius Lithuania Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Luxembourg GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Malta SmithKline Beecham plc Great West Road, Brentford, Middlesex TW8 9GS Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT United Kingdom Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Netherlands GlaxoSmithKline BV Huis ter Heideweg 62 3705 LZ Zeist The Netherlands Priorix Powder and solvent for solution for injection Subcutaneous use Norway GlaxoSmithKline AS Forskningsveien 2a Postboks 180 Vinderen 0319 Oslo Norway Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Poland GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Portugal Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda. Rua Dr. António Loureiro Borges, 3 Arquiparque – Miraflores 1495-131 Algés Portugal Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Romania GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Slovak Republic GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 1330 Rixensart Belgium Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use Slovenia GSK d.o.o., Ljubljana, Knezov štradon 90, 1000 Ljubljana Slovenia Priorix prašek in vehikel za raztopino za injiciranje Powder and solvent for solution for injection Subcutaneous use Intramuscular use Spain GlaxoSmithKline, S.A. C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) Spain Priorix polvo y disolvente en jeringa precargada para solución inyectable Powder and solvent for solution for injection Subcutaneous use Intramuscular use Sweden GlaxoSmithKline AB, Box 516, 169 29 Solna Sweden Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use United Kingdom SmithKline Beecham plc 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT United Kingdom Priorix Powder and solvent for solution for injection Subcutaneous use Intramuscular use

Anx_iv_list_of_the_names_pharmaceutical_form_strength_of_the_veterinary_medicinal_product_animal_species_route_of_administration_withdrawal_periods_applicant_in_the_member. states. Member State EU/EEA Applicant Name Pharmaceutical form INN/Strength Animal species Route of administration Recommended dose Withdrawal periods Austria Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Bulgaria Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Denmark Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Spain Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Finland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving France Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml solution pour pour on pour bovins Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Hungary Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Ireland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Iceland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving The Netherlands Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Norway Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Poland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Portugal Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Romania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Sweden (Applicant) Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Slovenia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT IN THE MEMBER STATES

Member State EU/EEA Applicant Name Pharmaceutical form INN/Strength Animal species Route of administration Recommended dose Withdrawal periods Austria Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Bulgaria Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Denmark Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Spain Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Finland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving France Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml solution pour pour on pour bovins Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Hungary Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Ireland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Iceland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving The Netherlands Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Norway Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Poland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Portugal Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Romania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Sweden (Applicant) Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving Slovenia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 5 mg/ml Pour-On Solution for Cattle Pour-on solution Doramectin 5 mg/ml Cattle topical - on the back of the animal 1 ml per 10 kg bodyweight CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Anx_v_list_of_the_names_pharmaceutical_form_strength_of_the_veterinary_medicinal_product_animal_species_route_of_administration_withdrawal_periods_applicant_in_the_member. states. Member State EU/EEA Applicant Name Pharmaceutical form INN/Strength Animal species Route of administration Recommended dose Withdrawal periods Austria Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Bulgaria Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Cyprus Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs – intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Czech Republic Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Denmark Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs – intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Estonia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Greece Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Spain Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Finland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. France Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution injectable pour bovins, ovins et porcins Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Hungary Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Ireland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Iceland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Latvia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Lithuania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Malta Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. The Netherlands Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Norway Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Poland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Portugal Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Romania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Sweden Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Slovenia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Slovakia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

ANNEX V LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT IN THE MEMBER STATES

Member State EU/EEA Applicant Name Pharmaceutical form INN/Strength Animal species Route of administration Recommended dose Withdrawal periods Austria Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Bulgaria Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Cyprus Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs – intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Czech Republic Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Denmark Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs – intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Estonia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Greece Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Spain Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Finland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. France Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution injectable pour bovins, ovins et porcins Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Hungary Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Ireland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Iceland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Latvia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Lithuania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Malta Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. The Netherlands Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Norway Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Poland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Portugal Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Romania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Sweden Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Slovenia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. Slovakia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Versions

1. 2012-06-29