# C_2012190EN.01001201.xml

| 29.6.2012 | EN | Official Journal of the European Union | C 190/12 |
| --- | --- | --- | --- |

29.6.2012

EN

Official Journal of the European Union

C 190/12

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2012 to 31 May 2012

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

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

1

or Article 38 of Directive 2001/82/EC

2

)

2012/C 190/02

—   Issuing, maintenance or modification of a national marketing authorization

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 |

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

---

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

1

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

2

---

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76

35041 Marburg,

Tyskland

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

---

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 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 (1) | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | GlaxoSmithKline Pharma GmbH |
| Albert Schweitzer-Gasse 6 |
| A-1140 Wien |
| Austria |

Member State EU/EEA

Marketing authorisation holder

(Invented) Name

Strength (1)

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

SmithKline Beecham plc

Great West Road,

Brentford,

Middlesex TW8 9GS

Trading as

| GlaxoSmithKline UK |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex |
| UB11 1BT |
| United Kingdom |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex UB11 1BT

United Kingdom

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

---

(1)  Strength applicable for all countries

After reconstitution, 1 dose (0,5 ml) contains:

| Live attenuated measles virus (Schwarz strain) | not less than 103.0 CCID50 |
| --- | --- |
| Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) | not less than 103.7 CCID50 |
| Live attenuated rubella virus (Wistar RA 27/3 strain) | not less than 103.0 CCID50 |

Live attenuated measles virus (Schwarz strain)

not less than 103.0 CCID50

Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain)

not less than 103.7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain)

not less than 103.0 CCID50

---

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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. |

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 |

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 |

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 |

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 |

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.

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