# EUR-Lex - 52005XC1230(01) - EN

Important legal notice

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# 52005XC1230(01)

**Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2005 to 19 November 2005 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) **

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Official Journal C 334 , 30/12/2005 P. 0032 - 0034 *

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2005 to 19 November 2005

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

(2005/C 334/06)

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

7.11.2005 | Abilify | Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom | EU/1/04/276/001-032 | 9.11.2005 |

7.11.2005 | Kivexa | Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/04/298/001-002 | 9.11.2005 |

7.11.2005 | Ziagen | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/99/112/001-002 | 9.11.2005 |

7.11.2005 | Rapamune | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/01/171/001-012 | 9.11.2005 |

7.11.2005 | Xagrid | Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295/001 | 9.11.2005 |

7.11.2005 | Emend | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/03/262/001-006 | 9.11.2005 |

15.11.2005 | Levitra | Bayer AG, D-51368 Leverkusen | EU/1/03/248/001-012 | 18.11.2005 |

15.11.2005 | Cialis - | Lilly ICOS Limited, St Bride's House — 10 Salisbury Square — London EC4Y 8EH — United Kingdom | EU/1/02/237/001-005 | 18.11.2005 |

15.11.2005 | Taxotere | Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex | EU/1/95/002/001-002 | 18.11.2005 |

15.11.2005 | NeuroBloc | Solstice Neurosciences Ltd, Fitzwilton House, Wilton Place, Dublin 2, Ireland | EU/1/00/166/001-003 | 21.11.2005 |

15.11.2005 | Vivanza — | Bayer AG, D-51368 Leverkusen | EU/1/03/249/001-012 | 18.11.2005 |

15.11.2005 | Viagra | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077/001-012 | 18.11.2005 |

15.11.2005 | PegIntron | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | EU/1/00/131/001-050 | 18.11.2005 |

15.11.2005 | CellCept | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005/001-006 | 18.11.2005 |

15.11.2005 | Ebixa | H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby | EU/1/02/219/001-013 | 18.11.2005 |

15.11.2005 | Arava | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | EU/1/99/118/001-010 | 18.11.2005 |

15.11.2005 | Avandamet | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex,TW8 9GS United Kingdom | EU/1/03/258/001-014 | 18.11.2005 |

15.11.2005 | Xigris | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/02/225/001-002 | 18.11.2005 |

15.11.2005 | Emtriva | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | EU/1/03/261/001-003 | 18.11.2005 |

15.11.2005 | Viramune | Boehringer Ingelheim International GmbH, Binger Strasse 173- D — 55216 Ingelheim am Rhein | EU/1/97/055/001-003 | 18.11.2005 |

15.11.2005 | Tracleer | Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220/001-005 | 18.11.2005 |

15.11.2005 | Viraferonpeg | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | EU/1/00/132/001-050 | 18.11.2005 |

15.11.2005 | Zevalin | Schering AG, Müllerstrasse 170-178, D — 13342 Berlin | EU/1/03/264/001 | 18.11.2005 |

15.11.2005 | Ariclaim | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein | EU/1/04/283/001-007 | 18.11.2005 |

15.11.2005 | Mabthera | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/067/001-002 | 18.11.2005 |

15.11.2005 | Advate | Baxter AG, Industriestraße 67, A-1221 Wien | EU/1/03/271/001-004 | 18.11.2005 |

15.11.2005 | Temodal | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles | EU/1/98/096/001-008 | 18.11.2005 |

15.11.2005 | Somavert | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/240/001-004 | 23.11.2005 |

15.11.2005 | Axura | Merz Pharmaceuticals GmbH, Eckenheimer Landstr. 100-104, D-60318 Frankfurt/Main | EU/1/02/218/001-011 | 18.11.2005 |

16.11.2005 | NovoSeven | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd | EU/1/96/006/001-003 | 21.11.2005 |

16.11.2005 | Truvada | Gilead Sciences International Limited, Granta Park Abington Cambridge CB1 6GT United Kingdom | EU/1/04/305/001 | 18.11.2005 |

17.11.2005 | Lyrica | PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/04/279/001-032 | 18.11.2005 |

17.11.2005 | Integrilin | Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/99/109/001-002 | 21.11.2005 |

17.11.2005 | Yentreve | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/280/001-007 | 21.11.2005 |

17.11.2005 | NeoRecormon | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/97/031/001-003 EU/1/97/031/019-046 | 21.11.2005 |

17.11.2005 | REYATAZ | Bristol — Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom | EU/1/03/267/001-007 | 21.11.2005 |

17.11.2005 | Panretin | Ligand Pharmaceuticals UK Ltd, Innovis House, 108 High Street, Crawley, West Sussex RH10 1BB, United Kingdom | EU/1/00/149/001 | 21.11.2005 |

17.11.2005 | Agenerase | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/00/148/001-004 | 21.11.2005 |

17.11.2005 | Infanrix Hexa | GlaxoSmithKline Biologicals SA, rue de l'Institut 89, B-1330 Rixensart | EU/1/00/152/001-018 | 21.11.2005 |

17.11.2005 | Infanrix Penta | GlaxoSmithKline Biologicals SA, rue de l'Institut 89, B-1330 Rixensart | EU/1/00/153/001-010 | 21.11.2005 |

17.11.2005 | Emselex | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/04/294/001-028 | 21.11.2005 |

— Suspension of a marketing authorization (Article 18 of Council Regulation (EEC) No 2309/93)

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 |

17.11.2005 | Hexavac | Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, F-69007 Lyon | EU/1/00/147/001-012 | 21.11.2005 |

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

17.11.2005 | Pruban | Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/00/024/001 | 21.11.2005 |

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

London E14 4HB

United Kingdom

[1] OJ L 214, 24.8.1993, p. 1.

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