EN Official Journal of the European Union C 334/32

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.