EN Official Journal of the European Union C 287/7

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006

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

(2006/C 287/03)

— 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 4.10.2006 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom EU/1/04/276/036 6.10.2006 4.10.2006 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom EU/1/04/276/036 6.10.2006 6.10.2006 Travatan Alcon Laboratories (UK) Ltd. Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/01/199/001-002 10.10.2006 11.10.2006 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 13.10.2006 17.10.2006 Cetrotide Serono Europe Ltd. 56, Marsh Wall London E14 9TP United Kingdom EU/1/99/100/001-003 19.10.2006 19.10.2006 Zometa Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/176/001-006 23.10.2006 19.10.2006 Zevalin Schering AG Müllerstrasse 170-178 D-13342 Berlin EU/1/03/264/001 23.10.2006 20.10.2006 Herceptin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/00/145/001 24.10.2006 20.10.2006 PritorPlus Bayer HealthCare AG D-51368 Leverkusen EU/1/02/215/001-012 24.10.2006 20.10.2006 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire, SL6 0PH United Kingdom EU/1/99/126/001-018 24.10.2006 20.10.2006 Caelyx Schering Plough Europe Rue de Stalle 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/96/011/001-004 24.10.2006 20.10.2006 Avonex Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kingdom EU/1/97/033/001-003 24.10.2006 20.10.2006 Faslodex AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom EU/1/03/269/001 24.10.2006 20.10.2006 ViraferonPeg Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/00/132/001-050 24.10.2006 23.10.2006 Taxotere Aventis Pharma S.A., 20 Avenue Raymond Aron, Antony Cedex 92165, France EU/1/95/002/001-002 25.10.2006 23.10.2006 PhotoBarr Axcan Pharma International BV Engelenkampstraat 72 6131 JJ Sittard Nederland EU/1/04/272/001-002 25.10.2006 23.10.2006 Dynepo Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/02/211/001-005 26.10.2006 24.10.2006 PegIntron Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/00/131/001-050 25.10.2006 24.10.2006 AVANDIA SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/00/137/002-018 26.10.2006 24.10.2006 Aclasta Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/308/001-002 26.10.2006 24.10.2006 Prometax Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/092/001-018 26.10.2006 24.10.2006 Invanz Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/02/216/001-002 26.10.2006 24.10.2006 Apidra Sanofi-Aventis Deutschland GmbH Brueningstrasse, 50 D-65926 Frankfurt am Main EU/1/04/285/013-020 26.10.2006 24.10.2006 Fuzeon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/252/001-003 26.10.2006 24.10.2006 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/03/258/001-022 26.10.2006 26.10.2006 Ketek Aventis Pharma S.A. 20 Avenue Raymond Aron F-92160 Antony EU/1/01/191/001-005 30.10.2006 26.10.2006 Levviax Aventis Pharma S.A. 20 Avenue Raymond Aron F-92160 Antony EU/1/01/192/001-005 30.10.2006 26.10.2006 Actos Takeda Global Research and Development Centre (Europe) Ltd, Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/00/150/001-024 30.10.2006 26.10.2006 Glustin Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/00/151/001-022 30.10.2006 26.10.2006 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/99/110/001-009 30.10.2006 26.10.2006 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/001-009 30.10.2006 26.10.2006 Exelon Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/066/001-018 30.10.2006 26.10.2006 Helixate NexGen Bayer AG D-51368 Leverkusen, EU/1/00/144/001-003 30.10.2006 26.10.2006 Vfend Pfizer Limited, Sandwich Kent CT13 9NJ United Kingdom EU/1/02/212/001-026 30.10.2006 27.10.2006 Pritor Bayer HealthCare AG D-51368 Leverkusen EU/1/98/089/001-019 31.10.2006 27.10.2006 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/04/283/001-007 31.10.2006 27.10.2006 Rebetol Schering Plough Europe Rue de Stalle 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/99/107/001-005 31.10.2006 27.10.2006 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 31.10.2006 27.10.2006 Avaglim SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/06/349/001-008 31.10.2006 27.10.2006 Viramune Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-003 31.10.2006 27.10.2006 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 31.10.2006 27.10.2006 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/220/001-005 31.10.2006 30.10.2006 FOSAVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/05/310/001-005 1.11.2006 30.10.2006 Lyrica PFIZER Ltd, Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/001-035 1.11.2006 30.10.2006 NutropinAq IPSEN Limited, 190 Bath Road Slough, Berkshire SLI 3XE United Kingdom EU/1/00/164/003-005 1.11.2006 30.10.2006 Keppra UCB S.A. Allée de la recherche 60 B-Bruxelles 1070 Researchdreef, 60 B-Brussel 1070 EU/1/00/146/001-030 3.11.2006 30.10.2006 Noxafil SP Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/05/320/001 2.11.2006 30.10.2006 Posaconazole SP SP Europe Rue de Stalle 73 B-1180 Bruxelles Stallestraat 73 — B-1180 Brussel EU/1/05/321/001 2.11.2006 30.10.2006 Nespo Dompé Biotec S.p.A. Via San Martino 12 I-20122 Milano EU/1/01/184/001-068 2.11.2006 30.10.2006 Aranesp Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-068 1.11.2006 31.10.2006 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/134/001-037 14.11.2006 31.10.2006 Insuman Aventis Pharma Deutschland GmbH Brueningstrasse 50 D-65926 Frankfurt am Main EU/1/97/030/065-084 6.11.2006 31.10.2006 Optruma Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/98/074/001-004 6.11.2006 31.10.2006 Evista Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/98/073/001-004 6.11.2006 31.10.2006 Telzir Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 7.11.2006

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 136 of 30 April 2004, page 1