# C_2005104EN.01001501.xml

| 29.4.2005 | EN | Official Journal of the European Union | C 104/15 |
| --- | --- | --- | --- |

29.4.2005

EN

Official Journal of the European Union

C 104/15

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Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 March 2005 to 15 April 2005

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) (1)

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) (1

(2005/C 104/04)

—   Issuing of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 22.3.2005 | Aloxi | Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddart, Dublin 15, Republic of Ireland | EU/1/04/306/001 | 24.3.2005 |
| 15.4.2005 | Aclasta | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/308/001 | 19.4.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

22.3.2005

Aloxi

Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddart, Dublin 15, Republic of Ireland

EU/1/04/306/001

24.3.2005

15.4.2005

Aclasta

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/308/001

19.4.2005

—   Modification of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.3.2005 | Thyrogen | Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/99/122/001-002 | 18.3.2005 |
| 22.3.2005 | Zometa | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/176/001-006 | 24.3.2005 |
| 22.3.2005 | PegIntron | Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique — Stallestraat, 73 — 1180 Brussel, België | EU/1/00/131/001-050 | 24.3.2005 |
| 22.3.2005 | ViraferonPeg | Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique — Stallestraat, 73 — 1180 Brussel, België | EU/1/00/132/001-050 | 24.3.2005 |
| 22.3.2005 | Aldurazyme | Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/03/253/001-003 | 24.3.2005 |
| 29.3.2005 | Foscan | Biolitec pharma (Ireland) Ltd., Unit 2, Broomhill Business Park, Broomhill Road,Tallaght, Dublin 24, Ireland | EU/1/01/197/001-002 | 1.4.2005 |
| 29.3.2005 | Cialis | Lilly ICOS Limited, St Bride's House — 10 Salisbury Square — London EC4Y 8EH — United Kingdom. | EU/1/02/237/001-005 | 31.3.2005 |
| 29.3.2005 | Inductos | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/02/226/001 | 31.3.2005 |
| 29.3.2005 | Ammonaps | Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense, France | EU/1/99/120/001-004 | 31.3.2005 |
| 29.3.2005 | NeuroBloc | Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland | EU/1/00/166/001-003 | 4.4.2005 |
| 29.3.2005 | Levitra | Bayer AG, D-51368 Leverkusen, Deutschland | EU/1/03/248/001-012 | 31.3.2005 |
| 29.3.2005 | Vivanza | Bayer AG, D-51368 Leverkusen, Deutschland | EU/1/03/249/001-012 | 31.3.2005 |
| 29.3.2005 | Uprima | Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | EU/1/01/180/001-010 | 31.3.2005 |
| 29.3.2005 | Viagra | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077/001-012 | 31.3.2005 |
| 29.3.2005 | Vfend | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/212/001-026 | 31.3.2005 |
| 29.3.2005 | Mirapexin | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/051/001-006
  EU/1/97/051/009-012 | 31.3.2005 |
| 29.3.2005 | Stalevo | Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi | EU/1/03/260/001-012 | 31.3.2005 |
| 29.3.2005 | Zeffix | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/99/114/001-003 | 31.3.2005 |
| 29.3.2005 | Levemir | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/04/278/001-009 | 31.3.2005 |
| 29.3.2005 | Visudyne | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/00/140/001 | 31.3.2005 |
| 29.3.2005 | HBVAXPRO | Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France | EU/1/01/183/019 | 31.3.2005 |
| 30.3.2005 | Xeloda | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/00/163/001-002 | 1.4.2005 |
| 30.3.2005 | NovoRapid | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/99/119/001
  EU/1/99/119/003
  EU/1/99/119/005-014 | 1.4.2005 |
| 30.3.2005 | Glivec | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/198/001-013 | 1.4.2005 |
| 30.3.2005 | Bondenza | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/03/266/001-002 | 1.4.2005 |
| 30.3.2005 | Sifrol | Boehringer Ingelheim International GmbH, Binger Strasse 173- D — 55216 Ingelheim am Rhein, Deutschland | EU/1/97/050/001-006
  EU/1/97/050/009-012 | 1.4.2005 |
| 30.3.2005 | Abilify | Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom | EU/1/04/276/001-020 | 1.4.2005 |
| 30.3.2005 | EMEND | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/03/262/001-006 | 1.4.2005 |
| 11.4.2005 | Cerezyme | Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/97/053/001-005 | 13.4.2005 |
| 11.4.2005 | Fuzeon | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/03/252/001-002 | 13.4.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

16.3.2005

Thyrogen

Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland

EU/1/99/122/001-002

18.3.2005

22.3.2005

Zometa

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/176/001-006

24.3.2005

22.3.2005

PegIntron

Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique — Stallestraat, 73 — 1180 Brussel, België

EU/1/00/131/001-050

24.3.2005

22.3.2005

ViraferonPeg

Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique — Stallestraat, 73 — 1180 Brussel, België

EU/1/00/132/001-050

24.3.2005

22.3.2005

Aldurazyme

Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland

EU/1/03/253/001-003

24.3.2005

29.3.2005

Foscan

Biolitec pharma (Ireland) Ltd., Unit 2, Broomhill Business Park, Broomhill Road,Tallaght, Dublin 24, Ireland

EU/1/01/197/001-002

1.4.2005

29.3.2005

Cialis

Lilly ICOS Limited, St Bride's House — 10 Salisbury Square — London EC4Y 8EH — United Kingdom.

EU/1/02/237/001-005

31.3.2005

29.3.2005

Inductos

Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/02/226/001

31.3.2005

29.3.2005

Ammonaps

Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense, France

EU/1/99/120/001-004

31.3.2005

29.3.2005

NeuroBloc

Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland

EU/1/00/166/001-003

4.4.2005

29.3.2005

Levitra

Bayer AG, D-51368 Leverkusen, Deutschland

EU/1/03/248/001-012

31.3.2005

29.3.2005

Vivanza

Bayer AG, D-51368 Leverkusen, Deutschland

EU/1/03/249/001-012

31.3.2005

29.3.2005

Uprima

Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom

EU/1/01/180/001-010

31.3.2005

29.3.2005

Viagra

Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/98/077/001-012

31.3.2005

29.3.2005

Vfend

Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/02/212/001-026

31.3.2005

29.3.2005

Mirapexin

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/051/001-006

EU/1/97/051/009-012

31.3.2005

29.3.2005

Stalevo

Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi

EU/1/03/260/001-012

31.3.2005

29.3.2005

Zeffix

Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/99/114/001-003

31.3.2005

29.3.2005

Levemir

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278/001-009

31.3.2005

29.3.2005

Visudyne

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/00/140/001

31.3.2005

29.3.2005

HBVAXPRO

Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France

EU/1/01/183/019

31.3.2005

30.3.2005

Xeloda

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/00/163/001-002

1.4.2005

30.3.2005

NovoRapid

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-014

1.4.2005

30.3.2005

Glivec

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/198/001-013

1.4.2005

30.3.2005

Bondenza

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/03/266/001-002

1.4.2005

30.3.2005

Sifrol

Boehringer Ingelheim International GmbH, Binger Strasse 173- D — 55216 Ingelheim am Rhein, Deutschland

EU/1/97/050/001-006

EU/1/97/050/009-012

1.4.2005

30.3.2005

Abilify

Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom

EU/1/04/276/001-020

1.4.2005

30.3.2005

EMEND

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/03/262/001-006

1.4.2005

11.4.2005

Cerezyme

Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland

EU/1/97/053/001-005

13.4.2005

11.4.2005

Fuzeon

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/03/252/001-002

13.4.2005

—   Modification of a marketing authorisation (Article 34 of Council Regulation (EEC) No 2309/93): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.3.2005 | Eurifel FeLV | Merial, 29 Avenue Tony Garnier, 69007 Lyon, France | EU/2/00/019/005-007 | 18.3.2005 |
| 11.4.2005 | Incurin | Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/00/018/001 | 14.4.2005 |
| 11.4.2005 | Rabigen SAG2 | VIRBAC S.A., 1ere Avenue 2065 m L.I.D. — 06516 Carros — France | EU/2/00/021/001-002 | 13.4.2005 |
| 15.4.2005 | Aivlosin | ECO Animal Health Ltd, 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | EU/2/04/044/001 | 19.4.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

16.3.2005

Eurifel FeLV

Merial, 29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/00/019/005-007

18.3.2005

11.4.2005

Incurin

Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/00/018/001

14.4.2005

11.4.2005

Rabigen SAG2

VIRBAC S.A., 1ere Avenue 2065 m L.I.D. — 06516 Carros — France

EU/2/00/021/001-002

13.4.2005

15.4.2005

Aivlosin

ECO Animal Health Ltd, 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom

EU/2/04/044/001

19.4.2005

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 4HB |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK — London E14 4HB

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(1)  OJ L 214 of 24.8.1993, p. 1.

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