EN Official Journal of the European Union C 176/19

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2006 to 30 June 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 176/09)

— Issuing 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 INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 19.6.2006 ACOMPLIA rimonabant Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/344/001-009 Film-coated tablet (Non applicable) 21.6.2006 19.6.2006 Zimulti rimonabant Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/345/001-009 Film-coated tablet (Non applicable) 21.6.2006 26.6.2006 Baraclude entecavir Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/06/343/001-004 EU/1/06/343/005 Film-coated tablet Oral solution J05AF10 28.6.2006 27.6.2006 Avaglim rosiglitazone/glimépiride SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/06/349/001-008 Film-coated tablet (Non applicable) 29.6.2006 27.6.2006 RotaTeq Rotavirus vaccine (live, oral) Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/348/001-002 Oral solution (Non applicable) 29.6.2006 27.6.2006 Tysabri natalizumab Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland EU/1/06/346/001 Concentrate for solution for infusion L04AA23 30.6.2006

— 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 1.6.2006 Zometa Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/176/001-006 5.6.2006 1.6.2006 Humira Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-006 5.6.2006 1.6.2006 Betaferon Schering Aktiengesellschaft D-13342 Berlin EU/1/95/003/003-004 6.6.2006 2.6.2006 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/03/258/001-022 8.6.2006 8.6.2006 Dynepo Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/02/211/001-005 12.6.2006 8.6.2006 Ventavis Schering AG Müllerstrasse 170-178 D-13342 Berlin EU/1/03/255/001-003 12.6.2006 8.6.2006 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/97/049/001-033 12.6.2006 8.6.2006 Viagra Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom EU/1/98/077/001-012 12.6.2006 12.6.2006 Cialis Lilly ICOS Limited St Bride's House 10 Salisbury Square London EC4Y 8EH United Kingdom EU/1/02/237/001-005 14.6.2006 12.6.2006 Vivanza Bayer AG D-51368 Leverkusen EU/1/03/249/001-012 16.6.2006 12.6.2006 Levitra Bayer AG D-51368 Leverkusen EU/1/03/248/001-012 16.6.2006 12.6.2006 Zerene Wyeth Research (UK) Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/099/001-006 14.6.2006 12.6.2006 Protopy Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/02/202/001-006 14.6.2006 12.6.2006 Protopic Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/02/201/001-006 14.6.2006 12.6.2006 Sonata Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/102/001-008 14.6.2006 16.6.2006 DaTSCAN GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom EU/1/00/135/001-002 20.6.2006 16.6.2006 Revatio PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/318/001 20.6.2006 19.6.2006 DepoCyte SkyePharma PLC 105 Piccadilly London W1J 7NJ United Kingdom EU/1/01/187/001 21.6.2006 26.6.2006 Bondronat Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/012/004 EU/1/96/012/009-013 28.6.2006 26.6.2006 GONAL-f Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/95/001/001 EU/1/95/001/003-005 EU/1/95/001/009 EU/1/95/001/012 EU/1/95/001/021-022 EU/1/95/001/025-028 EU/1/95/001/031-035 28.6.2006 26.6.2006 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/220/001-005 28.6.2006 26.6.2006 Renagel Genzyme Europe B.V. Gooimeer 10 Naarden 1411 DD Nederland EU/1/99/123/001-011 28.6.2006 26.6.2006 Carbaglu Orphan Europe Immeuble ‘Le Guillaumet’ F-92046 Paris La Défense EU/1/02/246/001-003 28.6.2006 26.6.2006 Iscover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/98/070/001a-001b EU/1/98/070/002a-002b EU/1/98/070/003a-003b EU/1/98/070/004a-004b 28.6.2006 26.6.2006 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/98/090/015-016 28.6.2006 26.6.2006 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/02/213/011-012 28.6.2006 26.6.2006 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France F-75013 Paris EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b 28.6.2006 26.6.2006 Zenapax Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City, AL7 1TW United Kingdom EU/1/99/098/001-002 28.6.2006 27.6.2006 Kaletra Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/004-005 29.6.2006

— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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 26.6.2006 Fortovase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City, AL7 1TW United Kingdom EU/1/98/075/001-002 28.6.2006

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 19.6.2006 Convenia cefovecine Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/06/059/001 Powder and solvent for solution for injection QJ01DD91 21.6.2006

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 30.4.2004, p. 1.