ISSN 1977-091X

doi:10.3000/1977091X.C_2012.190.eng

Official Journal

of the European Union

C 190

European flag  

English edition

Information and Notices

Volume 55
29 June 2012


Notice No

Contents

page

 

IV   Notices

 

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

 

European Commission

2012/C 190/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2012 to 31 May 2012(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2012/C 190/02

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)

12

EN

 


IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

29.6.2012   

EN

Official Journal of the European Union

C 190/1


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

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council  (1) )

2012/C 190/01

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

7.5.2012

Riluzole Zentiva

Riluzole

Aventis Pharma S.A.

20 avenue Raymond Aron,

F-92165 Antony Cedex,

France

EU/1/12/768/001

Film-coated tablet

N07XX02

10.5.2012

10.5.2012

Pixuvri

pixantrone

CTI Life Sciences Ltd

Biopark, Broadwater Road,

Welwyn Garden City,

Hertfordshire AL73AX,

United Kingdom

EU/1/12/764/001

powder for concentrate for solution for infusion

L01DB11

14.5.2012

22.5.2012

Docetaxel Accord

Docetaxel

Accord Healthcare Limited

Sage house, 319 Pinner road,

North Harrow,

Middlesex HA1 4HF

United Kingdom

EU/1/12/769/001-003

Concentrate for solution for infusion

L01CD02

25.5.2012

22.5.2012

Docetaxel Kabi

Docetaxel

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road,

Bordon,

Hampshire,

GU35 0NF,

United Kingdom

EU/1/12/770/001-004

Concentrate for solution for infusion

L01CD02

25.5.2012


—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

7.5.2012

Intanza

Sanofi Pasteur MSD SNC

8, rue Jonas Salk,

Lyon 69007,

France

EU/1/08/505/001-003

9.5.2012

7.5.2012

Ovitrelle

Merck Serono Europe Limited

56, Marsh Wall,

London E14 9TP,

United Kingdom

EU/1/00/165/001-003

9.5.2012

10.5.2012

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park,

Oxford Road,

Uxbridge,

Middlesex UB8 1HU,

United Kingdom

EU/1/04/276/001-020

EU/1/04/276/024-036

14.5.2012

10.5.2012

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France -

75013 Paris,

France

EU/1/98/086/001-034

14.5.2012

10.5.2012

Ibandronic Acid Teva

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/642/001-004

14.5.2012

10.5.2012

Irbesartan / Hydrochlorothiazide Teva

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/583/001-072

14.5.2012

10.5.2012

Siklos

ADDMEDICA

101, rue Saint Lazare,

Paris 75009,

France

EU/1/07/397/001-004

14.5.2012

10.5.2012

Telmisartan Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76 78,

220 Hafnarfjörður,

Iceland

EU/1/10/639/001-030

14.5.2012

10.5.2012

Telmisartan Teva

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/610/001-060

14.5.2012

10.5.2012

Trobalt

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/11/681/001-013

14.5.2012

14.5.2012

Brilique

AstraZeneca AB

Södertälje S 151 85,

Sverige

EU/1/10/655/001-006

16.5.2012

14.5.2012

Invega

Janssen-Cilag International NV

Turnhoutseweg, 30 -

2340 Beerse –

België

EU/1/07/395/001-095

16.5.2012

14.5.2012

JEVTANA

SANOFI

174, avenue de France,

F-75013 Paris,

France

EU/1/11/676/001

16.5.2012

14.5.2012

Luveris

Merck Serono Europe Limited

56, Marsh Wall,

London E14 9TP,

United Kingdom

EU/1/00/155/001-003

16.5.2012

14.5.2012

Possia

AstraZeneca AB

Södertälje S 151 85,

Sverige

EU/1/10/656/001-006

16.5.2012

14.5.2012

TOBI Podhaler

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/10/652/001-003

16.5.2012

15.5.2012

Mircera

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/07/400/008-013

EU/1/07/400/017-024

17.5.2012

15.5.2012

Topotecan Hospira

Hospira UK Limited

Queensway,

Royal Leamington Spa,

Warwickshire CV31 3RW,

United Kingdom

EU/1/10/633/001-002

17.5.2012

15.5.2012

Vizarsin

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/09/551/001-027

17.5.2012

22.5.2012

Aerinaze

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/07/399/001-006

25.5.2012

22.5.2012

Fampyra

Biogen Idec Limited

Innovation House,

70 Norden Road,

Maidenhead,

Berkshire SL6 4AY,

United Kingdom

EU/1/11/699/001-004

25.5.2012

22.5.2012

Gardasil

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/357/001-008

EU/1/06/357/018-021

25.5.2012

22.5.2012

HALAVEN

Eisai Europe Limited

European Knowledge Centre,

Mosquito Way,

Hatfield,

Hertsforshire AL10 9SN,

United Kingdom

EU/1/11/678/001-002

25.5.2012

22.5.2012

Hizentra

CSL Behring GmbH

Emil-von-Behring-Strasse 76,

35041 Marburg,

Deutschland

EU/1/11/687/001-012

25.5.2012

22.5.2012

IDflu

Sanofi Pasteur SA

2, avenue Pont Pasteur,

F-69007 Lyon,

France

EU/1/08/507/001-003

25.5.2012

22.5.2012

Pergoveris

Merck Serono Europe Limited

56, Marsh Wall,

London E14 9TP,

United Kingdom

EU/1/07/396/001-003

25.5.2012

22.5.2012

Silgard

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/06/358/001-008

EU/1/06/358/018-021

25.5.2012

22.5.2012

Tamiflu

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/02/222/001-005

24.5.2012

22.5.2012

Tamiflu

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/02/222/001-005

25.5.2012

22.5.2012

Votrient

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/10/628/001-004

25.5.2012

25.5.2012

Benlysta

Glaxo Group Limited

Glaxo Wellcome House,

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/11/700/001-002

30.5.2012

25.5.2012

Betaferon

Bayer Pharma AG

D - 13342 Berlin,

Deutschland

EU/1/95/003/003-012

30.5.2012

25.5.2012

Busilvex

Pierre Fabre Médicament

45, Place Abel Gance,

92654 Boulogne Billancourt Cedex,

France

EU/1/03/254/002

31.5.2012

25.5.2012

Clopidogrel Teva Pharma B.V.

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/649/001-016

30.5.2012

25.5.2012

Conbriza

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/09/511/001-005

31.5.2012

25.5.2012

DuoCover

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/10/623/001-015

30.5.2012

25.5.2012

Ecalta

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/07/416/001-002

31.5.2012

25.5.2012

Fosavance

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/05/310/001-009

30.5.2012

25.5.2012

Irbesartan Teva

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/576/001-039

30.5.2012

25.5.2012

Ixiaro

Intercell AG

Campus Vienna Biocenter 3

A-1030 Wien,

Österreich

EU/1/08/501/001-002

31.5.2012

25.5.2012

Keppra

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

Belgique/Researchdreef, 60,

Brussel 1070,

België

EU/1/00/146/001-032

1.6.2012

25.5.2012

Kinzalkomb

Bayer Pharma AG

Berlin 13342,

Deutschland

EU/1/02/214/001-015

31.5.2012

25.5.2012

Kinzalmono

Bayer Pharma AG

Berlin 13342,

Deutschland

EU/1/98/091/001-014

31.5.2012

25.5.2012

Kuvan

Merck Serono Europe Limited

56 Marsh Wall,

London E14 9TP,

United Kingdom

EU/1/08/481/001-003

30.5.2012

25.5.2012

Lamivudine / Zidovudine Teva

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/663/001-002

1.6.2012

25.5.2012

Micardis

Boehringer Ingelheim International GmbH

Binger Strasse 173-

D - 55216 Ingelheim am Rhein,

Deutschland

EU/1/98/090/001-022

31.5.2012

25.5.2012

MicardisPlus

Boehringer Ingelheim International GmbH

Binger Strasse 173-

D - 55216 Ingelheim am Rhein,

Deutschland

EU/1/02/213/001-023

31.5.2012

25.5.2012

Neulasta

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/02/227/001-002

EU/1/02/227/004

1.6.2012

25.5.2012

Nevirapine Teva

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/598/001-004

30.5.2012

25.5.2012

Onduarp

Boehringer Ingelheim International GmbH

Binger Str. 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/11/729/001-006

30.5.2012

25.5.2012

Optaflu

Novartis Vaccines and Diagnostics GmbH

Emil-von-Behring-Strasse 76,

D-35041 Marburg,

Deutschland

EU/1/07/394/001-009

31.5.2012

25.5.2012

Osseor

Les Laboratoires Servier

50, rue Carnot,

92284 Suresnes cedex,

France

EU/1/04/287/001-006

30.5.2012

25.5.2012

Pradaxa

Boehringer Ingelheim International GmbH

Binger Strasse 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/08/442/001-014

1.6.2012

25.5.2012

Pritor

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/98/089/001-022

30.5.2012

25.5.2012

PritorPlus

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/02/215/001-021

30.5.2012

25.5.2012

Protelos

Les Laboratoires Servier

50, rue Carnot,

92284 Suresnes cedex,

France

EU/1/04/288/001-006

 

25.5.2012

Rasilamlo

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/11/686/001-056

30.5.2012

25.5.2012

Rasilez

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/07/405/001-040

30.5.2012

25.5.2012

Rasilez HCT

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/08/491/001-080

31.5.2012

25.5.2012

Rasitrio

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/11/730/001-060

31.5.2012

25.5.2012

Riprazo

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/07/409/001-040

30.5.2012

25.5.2012

Riprazo HCT

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/11/680/001-080

1.6.2012

25.5.2012

Rivastigmine Actavis

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78,

Hafnarfjörður 220,

Iceland

EU/1/11/693/001-016

1.6.2012

25.5.2012

RoActemra

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/08/492/001-006

31.5.2012

25.5.2012

Sprimeo

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/07/407/001-040

31.5.2012

25.5.2012

Sprimeo HCT

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/11/683/001-080

1.6.2012

25.5.2012

Temozolomide Hospira

Hospira UK Ltd.

Queensway,

Royal Leamington Spa,

Warwickshire CV31 3RW,

United Kingdom

EU/1/10/615/001-002

EU/1/10/615/005-006

EU/1/10/615/009-010

EU/1/10/615/013-014

EU/1/10/615/017-018

EU/1/10/615/021-022

31.5.2012

25.5.2012

Tysabri

Elan Pharma International Ltd.

Treasury Building,

Lower Grand Canal Street,

Dublin 2,

IRELAND

EU/1/06/346/001

31.5.2012

25.5.2012

Vantavo

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/09/572/001-004

EU/1/09/572/006-008

30.5.2012

25.5.2012

Victoza

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/09/529/001-005

31.5.2012

25.5.2012

Vistide

Gilead Sciences International Limited

Cambridge,

CB21 6GT,

United Kingdom

EU/1/97/037/001

31.5.2012

25.5.2012

Volibris

Glaxo Group Ltd

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/08/451/001-004

30.5.2012

25.5.2012

Votrient

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/10/628/001-004

31.5.2012

25.5.2012

Xolair

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/05/319/001-010

30.5.2012

31.5.2012

Lamivudine Teva

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/566/001-005

4.6.2012

31.5.2012

Peyona

CHIESI FARMACEUTICI SpA

Via Palermo 26/A,

I-43100 Parma,

ITALIA

EU/1/09/528/001-002

4.6.2012

31.5.2012

Temozolomide Teva

Teva Pharma B.V.

Computerweg 10,

DR Utrecht 3542,

Nederland

EU/1/09/606/001-012

4.6.2012


—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

10.5.2012

Valtropin

BioPartners GmbH

Kaiserpassage 11 -

D-72764 Reutlingen,

Deutschland

EU/1/06/335/001

14.5.2012

25.5.2012

Docefrez

Sun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87,

2132 JH Hoofddorp,

Nederland

EU/1/10/630/001-002

31.5.2012

25.5.2012

Intrinsa

Warner Chilcott UK Ltd

Old Belfast Road,

Millbrook, Larne,

County Antrim BT40 2SH,

United Kingdom

EU/1/06/352/001-003

31.5.2012


—   Lift of suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

25.5.2012

Angiox

The Medicines Company UK Ltd

115 L Milton Park,

Abingdon,

Oxfordshire, OX14 4SA,

United Kingdom

EU/1/04/289/001

31.5.2012

25.5.2012

Caelyx

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/96/011/001-004

31.5.2012

25.5.2012

Luminity

Lantheus MI UK Limited

Festival House -

39 Oxford Street -

Newbury -

Berkshire RG14 1JG -

United Kingdom

EU/1/06/361/001-002

31.5.2012

25.5.2012

Mepact

IDM PHARMA SAS

11-15 quai De Dion Bouton,

92816 Puteaux Cedex,

France

EU/1/08/502/001

1.6.2012

25.5.2012

Soliris

Alexion Europe S.A.S.

25, boulevard de l’Amiral Bruix,

75016 Paris,

France

EU/1/07/393/001

31.5.2012

25.5.2012

Torisel

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

EU/1/07/424/001

30.5.2012

25.5.2012

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/04/274/001-002

31.5.2012

31.5.2012

Ceplene

EpiCept GmbH

Goethestrasse 4,

D-80336 München,

Deutschland

EU/1/08/477/001

4.6.2012


—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

10.5.2012

Circovac

Merial

29 Avenue Tony Garnier,

69007 Lyon,

France

EU/2/07/075/001-004

14.5.2012

10.5.2012

Netvax

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/09/093/001-002

14.5.2012

22.5.2012

Convenia

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/2/06/059/001-002

30.5.2012

22.5.2012

Equip WNV

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/2/08/086/001-003

25.5.2012

22.5.2012

PRILACTONE

CEVA SANTE ANIMALE

10 avenue de la Ballastière,

33500 Libourne,

France

EU/2/07/074/001-006

25.5.2012

25.5.2012

Onsior

Novartis Animal Health UK Ltd

Frimley Business Park,

Frimley/Camberley,

Surrey, GU16 7SR,

United Kingdom

EU/2/08/089/001-021

1.6.2012

25.5.2012

Suprelorin

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. -

06516 Carros –

France

EU/2/07/072/001-004

1.6.2012

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H


(1)  OJ L 136, 30.4.2004, p. 1.


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.