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Document 52012XC0629(03)

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 or Article 38 of Directive 2001/82/EC)

OJ C 190, 29.6.2012, p. 12–33 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

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) )

2012/C 190/02

—   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


(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, 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 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 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

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


(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


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


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.


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