EN Official Journal of the European Union C 241/1

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2005 to 31 August 2005

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

(2005/C 241/01)

— Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1)) 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 24.08.2005 FOSAVANCE Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310/001-005 26.08.2005

— Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1)) 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 01.08.2005 Crixivan Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United-Kingdom EU/1/96/024/001-005 EU/1/96/024/007-008 EU/1/96/024/010 03.08.2005 01.08.2005 Humira Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/256/001-006 03.08.2005 01.08.2005 Fabrazyme Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/01/188/001-006 03.08.2005 01.08.2005 Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-011 03.08.2005 01.08.2005 Trudexa Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/257/001-006 03.08.2005 01.08.2005 Remicade Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-003 03.08.2005 01.08.2005 Fasturtec Sanofi-Aventis, 174, avenue de France, F-75013 Paris, France EU/1/00/170/001-002 03.08.2005 01.08.2005 Comtan Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/081/001-004 03.08.2005 01.08.2005 Neulasta Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/02/227/001-002 03.08.2005 01.08.2005 Neupopeg Dompé Biotec S.p.A., Via San Martino, 12, I – 20122 Milano, Italia EU/1/02/228/001-002 03.08.2005 09.08.2005 Stocrin Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111/001-009 11.08.2005 09.08.2005 Sustiva Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom EU/1/99/110/001-009 11.08.2005 16.08.2005 Parareg Dompé Biotec S.p.A., Via San Martino, 12, I - 20122 Milano, Italia Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands EU/1/04/293/001-012 18.08.2005 16.08.2005 NeuroBloc Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland EU/1/00/166/001-003 18.08.2005 16.08.2005 MabCampath Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland ILEX Services Limited, 1 & 3 Frederick Sanger Road, The Surrey Research Park, Guildford Surrey, GU2 7YD, United Kingdom EU/1/01/193/001-002 18.08.2005 16.08.2005 Vivanza Bayer AG, D-51368 Leverkusen, Deutschland EU/1/03/249/001-012 18.08.2005 16.08.2005 Dukoral SBL Vaccin AB, S-105 21 Stockholm, Sweden EU/1/03/263/001-003 18.08.2005 16.08.2005 Levitra Bayer AG, D-51368 Leverkusen, Deutschland EU/1/03/248/001-013 18.08.2005 22.08.2005 Ferriprox Apotex Europe Ltd., Rowan House, 41 London Street, Reading, Berkshire, RG1 4PS, United Kingdom EU/1/99/108/001 24.08.2005 23.08.2005 BeneFIX Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/97/047/001-003 25.08.2005 24.08.2005 BeneFIX Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/97/047/001-003 26.08.2005 24.08.2005 REYATAZ Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom EU/1/03/267/001-007 26.08.2005 24.08.2005 Telzir Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/04/282/001-002 26.08.2005 24.08.2005 Agenerase Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/00/148/001-004 26.08.2005 24.08.2005 Kaletra Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/01/172/001-003 26.08.2005 24.08.2005 Fortovase Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/075/001-002 26.08.2005 26.08.2005 Pedea Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense, France EU/1/04/284/001 31.08.2005 26.08.2005 Neurobloc Solstice Neurosciences Ltd, Fitzwilton House, Wilton Place, Dublin 2, Ireland Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland EU/1/00/166/001-003 01.09.2005 30.08.2005 Stalevo Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi EU/1/03/260/001-012 01.09.2005 30.08.2005 Rebetol Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique – Stallestraat, 73 – 1180 Brussel, België EU/1/99/107/001-003 01.09.2005 31.08.2005 Neulasta Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/02/227/001-002 02.09.2005 31.08.2005 Renagel Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/99/123/001-011 05.09.2005 31.08.2005 Avonex Biogen Idec Ltd, 5 Roxborough Way, Foundation Park, Maidenhead, Berkshire, SL6 3UD, United Kindgom EU/1/97/033/001-003 02.09.2005 31.08.2005 Avonex Biogen Idec Ltd, 5 Roxborough Way, Foundation Park, Maidenhead, Berkshire, SL6 3UD, United Kindgom EU/1/97/033/001-003 02.09.2005 31.08.2005 Norvir Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom EU/1/96/016/001 EU/1/96/016/003 02.09.2005 31.08.2005 Neupopeg Dompé Biotec S.p.A., Via San Martino, 12, I – 20122 Milano, Italia EU/1/02/228/001-002 02.09.2005 31.08.2005 Invirase Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom EU/1/96/026/001-002 02.09.2005 31.08.2005 Zerit Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom EU/1/96/009/001-017 02.09.2005 31.08.2005 Zyprexa Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/96/022/002, EU/1/96/022/004, EU/1/96/022/006, EU/1/96/022/008-012, EU/1/96/022/014 EU/1/96/022/016-022 02.09.2005 31.08.2005 Zyprexa Velotab Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/99/125/001-008 02.09.2005

— Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1))

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 09.08.2005 Tenecteplase Boehringer Ingelheim Pharma GmbH co. KG Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/00/168/001-006 11.08.2005

— Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93 (1)) 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 01.08.2005 Metacam Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland EU/2/97/004/012-013 03.08.2005 18.08.2005 Quadrisol Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/97/005/001-003 EU/2/97/005/005-009 22.08.2005 18.08.2005 Pirsue PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/00/027/001-003 22.08.2005 25.08.2005 Novem Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland EU/2/04/042/001-002 29.08.2005 26.08.2005 Virbagen omega VIRBAC S.A., 1ere Avenue 2065 m L.I.D. - 06516 Carros - France EU/2/01/030/001-004 31.08.2005

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 UK - LONDON E14 4HB

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