# C_2004266EN.01000501.xml

| 29.10.2004 | EN | Official Journal of the European Union | C 266/5 |
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29.10.2004

EN

Official Journal of the European Union

C 266/5

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 September 2004 to 15 October 2004

(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

(2004/C 266/04)

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 |
| --- | --- | --- | --- | --- |
| 20.9.2004 | Angiox | The Medicines Company UK Ltd, Suite B, Park House, 11 Milton Park, Abingdon, Oxfordshire OX14 4RS, United Kingdom | EU/1/04/289/001 | 22.9.2004 |
| 20.9.2004 | Alimta | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/290/001 | 22.9.2004 |
| 20.9.2004 | Raptiva | Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/04/291/001-002 | 22.9.2004 |
| 21. 9.2004 | Protelos | Les Laboratoires Servier, 22, rue Garnier, F-92200 Neuilly-sur-Seine | EU/1/04/288/001-006 | 23.9.2004 |
| 21. 9.2004 | Osseor | Les Laboratoires Servier, 22, rue Garnier, F-92200 Neuilly-sur-Seine | EU/1/04/287/001-006 | 23.9.2004 |
| 27. 9.2004 | Apidra | Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, | EU/1/04/285/001-020 | 29. 9.2004 |
| 13.10.2004 | Wilzin | Orphan Europe SARL, Immeuble ‘Le Guillaumet’ F-92046 Paris-La-Défense | EU/1/04/286/001-002 | 18.10.2004 |

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

20.9.2004

Angiox

The Medicines Company UK Ltd, Suite B, Park House, 11 Milton Park, Abingdon, Oxfordshire OX14 4RS, United Kingdom

EU/1/04/289/001

22.9.2004

20.9.2004

Alimta

Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/290/001

22.9.2004

20.9.2004

Raptiva

Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/04/291/001-002

22.9.2004

21. 9.2004

Protelos

Les Laboratoires Servier, 22, rue Garnier, F-92200 Neuilly-sur-Seine

EU/1/04/288/001-006

23.9.2004

21. 9.2004

Osseor

Les Laboratoires Servier, 22, rue Garnier, F-92200 Neuilly-sur-Seine

EU/1/04/287/001-006

23.9.2004

27. 9.2004

Apidra

Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main,

EU/1/04/285/001-020

29. 9.2004

13.10.2004

Wilzin

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

EU/1/04/286/001-002

18.10.2004

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 |
| --- | --- | --- | --- | --- |
| 20.9.2004 | Remicade | Centocor BV, Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-003 | 22.9.2004 |
| 20.9.2004 | Azomyr | Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels | EU/1/00/157/014-021 | 22.9.2004 |
| 20.9.2004 | Aerius | Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels | EU/1/00/160/014-021 | 22.9.2004 |
| 20.9.2004 | Neoclarityn | Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels, | EU/1/00/161/014-021 | 22.9.2004 |
| 20.9.2004 | Lantus | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main, | EU/1/00/134/008-011
  EU/1/00/134/018-021 | 22.9.2004 |
| 20.9.2004 | Velcade | Millennium Pharmaceuticals, Ltd, Building 3, Chiswick Park, 566 Chiswick High Road, Chiswick, London, W4 5YA United Kingdom | EU/1/04/274/001 | 22.9.2004 |
| 20.9.2004 | Velcade | Janssen-Cilag International NV, Turnhoutsewe 30, B–2340 Beerse | EU/1/04/274/001 | 23.9.2004 |
| 20.9.2004 | Ovitrelle | Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/165/001-007 | 22.9.2004 |
| 21.9.2004 | Carbaglu | Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris-La-Défense | EU/1/02/246/001-002 | 23.9.2004 |
| 21.9.2004 | KOGENATE Bayer | Bayer AG, D-51368 Leverkusen, Deutschland | EU/1/00/143/004-006 | 23.9.2004 |
| 23.9.2004 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-003 | 27.9.2004 |
| 24.9.2004 | Insuman | Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, | EU/1/97/030/065-084 | 29.9.2004 |
| 24.9.2004 | InductOs | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/02/226/001 | 28.9.2004 |
| 24.9.2004 | Enbrel | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-003 | 28.9.2004 |
| 27.9.2004 | SonoVue | Bracco International BV, Strawinskylaan 3051, 1077ZX Amsterdam, Nederland | EU/1/01/177/001-002 | 29.9.2004 |
| 27.9.2004 | Ceprotin | Baxter AG, Industriesstrasse 67, 1220 Vienna, Österreich | EU/1/01/190/001-002 | 29.9.2004 |
| 27.9.2004 | Avonex | Biogen Idec France, ‘Le Capitole’ 55, avenue des Champs Pierreux, F-92012 Nanterre Cedex | EU/1/97/033/001-003 | 30. 9.2004 |
| 13.10.2004 | Revasc | Canyon Pharmaceuticals Ltd, 20-22 Bedford Row - WC1R 4JS London - United Kingdom | EU/1/97/043/001-002 | 19.10.2004 |
| Aventis Pharma SA, 20 Avenue Raymond Aron, Antony Cedex F-92165 | 18.10.2004 |
| 13.10.2004 | Arava | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | EU/1/99/118/001-010 | 18.10.2004 |
| 13.10.2004 | Vaniqa | Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/01/173/001-003 | 18.10.2004 |
| 13.10.2004 | NovoRapid | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd | EU/1/99/119/001-014 | 18.10.2004 |
| 13.10.2004 | Levviax | Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony | EU/1/01/192/001-005 | 19.10.2004 |
| 15.10.2004 | Ketek | Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony | EU/1/01/191/001-005 | 19.10.2004 |
| 15.10.2004 | Viramune | Boehringer Ingelheim International GmbH, Binger Strasse, 173 D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/055/001-002 | 19.10.2004 |
| 15.10.2004 | Fuzeon | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY | EU/1/03/252/001-003 | 20.10.2004 |
| 15.10.2004 | NovoRapid | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd | EU/1/99/119/001
  EU/1/99/119/003
  EU/1/99/119/005-014 | 19.10.2004 |

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

20.9.2004

Remicade

Centocor BV, Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-003

22.9.2004

20.9.2004

Azomyr

Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels

EU/1/00/157/014-021

22.9.2004

20.9.2004

Aerius

Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels

EU/1/00/160/014-021

22.9.2004

20.9.2004

Neoclarityn

Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels,

EU/1/00/161/014-021

22.9.2004

20.9.2004

Lantus

Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main,

EU/1/00/134/008-011

EU/1/00/134/018-021

22.9.2004

20.9.2004

Velcade

Millennium Pharmaceuticals, Ltd, Building 3, Chiswick Park, 566 Chiswick High Road, Chiswick, London, W4 5YA United Kingdom

EU/1/04/274/001

22.9.2004

20.9.2004

Velcade

Janssen-Cilag International NV, Turnhoutsewe 30, B–2340 Beerse

EU/1/04/274/001

23.9.2004

20.9.2004

Ovitrelle

Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/165/001-007

22.9.2004

21.9.2004

Carbaglu

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

EU/1/02/246/001-002

23.9.2004

21.9.2004

KOGENATE Bayer

Bayer AG, D-51368 Leverkusen, Deutschland

EU/1/00/143/004-006

23.9.2004

23.9.2004

Remicade

Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-003

27.9.2004

24.9.2004

Insuman

Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main,

EU/1/97/030/065-084

29.9.2004

24.9.2004

InductOs

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

EU/1/02/226/001

28.9.2004

24.9.2004

Enbrel

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

EU/1/99/126/001-003

28.9.2004

27.9.2004

SonoVue

Bracco International BV, Strawinskylaan 3051, 1077ZX Amsterdam, Nederland

EU/1/01/177/001-002

29.9.2004

27.9.2004

Ceprotin

Baxter AG, Industriesstrasse 67, 1220 Vienna, Österreich

EU/1/01/190/001-002

29.9.2004

27.9.2004

Avonex

Biogen Idec France, ‘Le Capitole’ 55, avenue des Champs Pierreux, F-92012 Nanterre Cedex

EU/1/97/033/001-003

30. 9.2004

13.10.2004

Revasc

Canyon Pharmaceuticals Ltd, 20-22 Bedford Row - WC1R 4JS London - United Kingdom

EU/1/97/043/001-002

19.10.2004

Aventis Pharma SA, 20 Avenue Raymond Aron, Antony Cedex F-92165

18.10.2004

13.10.2004

Arava

Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main

EU/1/99/118/001-010

18.10.2004

13.10.2004

Vaniqa

Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/01/173/001-003

18.10.2004

13.10.2004

NovoRapid

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

EU/1/99/119/001-014

18.10.2004

13.10.2004

Levviax

Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony

EU/1/01/192/001-005

19.10.2004

15.10.2004

Ketek

Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony

EU/1/01/191/001-005

19.10.2004

15.10.2004

Viramune

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

EU/1/97/055/001-002

19.10.2004

15.10.2004

Fuzeon

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

EU/1/03/252/001-003

20.10.2004

15.10.2004

NovoRapid

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

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-014

19.10.2004

Withdrawal of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93)

| 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 |
| --- | --- | --- | --- | --- |
| 28.9.2004 | Ixense | Takeda Europe R&D Centre Ltd, Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom | EU/1/01/181/001-007 | 30.9.2004 |

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

28.9.2004

Ixense

Takeda Europe R&D Centre Ltd, Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom

EU/1/01/181/001-007

30.9.2004

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

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