EN Official Journal of the European Union C 104/15

Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 March 2005 to 15 April 2005

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

(2005/C 104/04)

— Issuing of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorisation Number of the entry in the Community Register Date of notification 22.3.2005 Aloxi Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddart, Dublin 15, Republic of Ireland EU/1/04/306/001 24.3.2005 15.4.2005 Aclasta Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/308/001 19.4.2005

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

Date of the decision Name of the medicinal product Holder of the marketing authorisation Number of the entry in the Community Register Date of notification 16.3.2005 Thyrogen Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/99/122/001-002 18.3.2005 22.3.2005 Zometa Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/176/001-006 24.3.2005 22.3.2005 PegIntron Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique — Stallestraat, 73 — 1180 Brussel, België EU/1/00/131/001-050 24.3.2005 22.3.2005 ViraferonPeg Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique — Stallestraat, 73 — 1180 Brussel, België EU/1/00/132/001-050 24.3.2005 22.3.2005 Aldurazyme Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/03/253/001-003 24.3.2005 29.3.2005 Foscan Biolitec pharma (Ireland) Ltd., Unit 2, Broomhill Business Park, Broomhill Road,Tallaght, Dublin 24, Ireland EU/1/01/197/001-002 1.4.2005 29.3.2005 Cialis Lilly ICOS Limited, St Bride's House — 10 Salisbury Square — London EC4Y 8EH — United Kingdom. EU/1/02/237/001-005 31.3.2005 29.3.2005 Inductos Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/02/226/001 31.3.2005 29.3.2005 Ammonaps Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense, France EU/1/99/120/001-004 31.3.2005 29.3.2005 NeuroBloc Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland EU/1/00/166/001-003 4.4.2005 29.3.2005 Levitra Bayer AG, D-51368 Leverkusen, Deutschland EU/1/03/248/001-012 31.3.2005 29.3.2005 Vivanza Bayer AG, D-51368 Leverkusen, Deutschland EU/1/03/249/001-012 31.3.2005 29.3.2005 Uprima Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/01/180/001-010 31.3.2005 29.3.2005 Viagra Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/98/077/001-012 31.3.2005 29.3.2005 Vfend Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212/001-026 31.3.2005 29.3.2005 Mirapexin Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/051/001-006 EU/1/97/051/009-012 31.3.2005 29.3.2005 Stalevo Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi EU/1/03/260/001-012 31.3.2005 29.3.2005 Zeffix Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/99/114/001-003 31.3.2005 29.3.2005 Levemir Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278/001-009 31.3.2005 29.3.2005 Visudyne Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/00/140/001 31.3.2005 29.3.2005 HBVAXPRO Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France EU/1/01/183/019 31.3.2005 30.3.2005 Xeloda Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/00/163/001-002 1.4.2005 30.3.2005 NovoRapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-014 1.4.2005 30.3.2005 Glivec Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 1.4.2005 30.3.2005 Bondenza Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/03/266/001-002 1.4.2005 30.3.2005 Sifrol Boehringer Ingelheim International GmbH, Binger Strasse 173- D — 55216 Ingelheim am Rhein, Deutschland EU/1/97/050/001-006 EU/1/97/050/009-012 1.4.2005 30.3.2005 Abilify Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom EU/1/04/276/001-020 1.4.2005 30.3.2005 EMEND Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262/001-006 1.4.2005 11.4.2005 Cerezyme Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/97/053/001-005 13.4.2005 11.4.2005 Fuzeon Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/03/252/001-002 13.4.2005

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

Date of the decision Name of the medicinal product Holder of the marketing authorisation Number of the entry in the Community Register Date of notification 16.3.2005 Eurifel FeLV Merial, 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/00/019/005-007 18.3.2005 11.4.2005 Incurin Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/018/001 14.4.2005 11.4.2005 Rabigen SAG2 VIRBAC S.A., 1ere Avenue 2065 m L.I.D. — 06516 Carros — France EU/2/00/021/001-002 13.4.2005 15.4.2005 Aivlosin ECO Animal Health Ltd, 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001 19.4.2005

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.