EN Official Journal of the European Union C 237/4

Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 August 2004 to 15 September 2004

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

(2004/C 237/04)

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

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 7.9.2004 Yondelis Pharma Mar SA Sociedad Unipersonal, Avda de los Reyes, 1, P.I. La Mina-Norte E-28770 Colmenar Viejo, Madrid — 9.9.2004

— 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 17.8.2004 Cetrotide Serono Europe Ltd, 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/99/100/001-003 20.8.2004 18.8.2004 Cystagon Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense EU/1/97/039/001-004 23.8.2004 18.8.2004 BeneFIX Wyeth Europa Ltd, Huntercombe Lane, South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/97/047/001-003 23.8.2004 18.8.2004 Ziagen Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/99/112/001-002 23.8.2004 18.8.2004 Zavesca Actelion Registration Ltd, BSI Building, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/238/001 23.8.2004 23.8.2004 ViraferonPeg Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels EU/1/00/132/001-050 25.8.2004 23.8.2004 Tracleer Actelion Registration Ltd, BSI Building, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220/001-005 25.8.2004 23.8.2004 PegIntron Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels EU/1/00/131/001-050 25.8.2004 24.8.2004 NovoMix Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/00/142/004-005 EU/1/00/142/007-010 26.8.2004 24.8.2004 NovoRapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/99/119/001, EU/1/99/119/003, EU/1/99/119/005-014 26.8.2004 31.8.2004 Luveris Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/155/001-006 2.9.2004 31.8.2004 Ixense Takeda Europe R&D Centre Ltd, Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom EU/1/01/181/001-007 2.9.2004 31.8.2004 Tasmar Roche Registration Ltd, 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom EU/1/97/044/001-006 2.9.2004 31.8.2004 Lantus Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/00/134/022-029 2.9.2004 31.8.2004 Lantus Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/00/134/005-007 EU/1/00/134/013-017 2.9.2004 31.8.2004 Optisulin Aventis Pharma Deutschland GmbH, D-65926, Frankfurt am Main, Deutschland EU/1/00/133/005-007 2.9.2004 2.9.2004 Rebetol Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels EU/1/99/107/001-003 6.9.2004 2.9.2004 Ferriprox Apotex Europe Ltd, Rowan House, 41 London Street, Reading, Berkshire, RG1 4PS, United Kingdom EU/1/99/108/001 6.9.2004 2.9.2004 Avandamet SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/03/258/007-012 6.9.2004 2.9.2004 Rapamune Wyeth Europa Limited, Huntercombe Lane, South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/01/171/001-010 6.9.2004 2.9.2004 Integrilin Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels EU/1/99/109/001-002 6.9.2004 2.9.2004 Refludan Pharmion Limited, Granta Park, McClintock Building, Granta Park, Great Abington, Cambridge, CB1 6GX, United KingdomSchering AG, Müllerstrasse 170-178, D-13342 Berlin EU/1/97/035/001-004 6.9.2004 9.9.2004 Aranesp Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Netherlands EU/1/01/185/001-032 13.9.2004 9.9.2004 Trisenox Cell Therapeutics (UK) Ltd, 100 Pall Mall, London SW1Y 5HP, United Kingdom EU/1/02/204/001 13.9.2004 9.9.2004 Kaletra Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/01/172/001-003 13.9.2004 9.9.2004 Kaletra Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/01/172/001-003 13.9.2004 9.9.2004 Crixivan Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/024/001-010 13.9.2004 9.9.2004 Nespo Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano EU/1/01/184/001-032 13.9.2004 9.9.2004 Rebetol Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels EU/1/99/107/001-003 13.9.2004 9.9.2004 Fortovase Roche Registration Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/075/001-002 13.9.2004 9.9.2004 Synagis Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/99/117/001-002 13.9.2004 10.9.2004 Invirase Roche Registration Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom EU/1/96/026/001 14.9.2004 13.9.2004 IntronA Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels EU/1/99/127/001-044 15.9.2004 13.9.2004 Viraferon Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels EU/1/99/128/001-037 15.9.2004 13.9.2004 Tracleer Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220/001-005 15.9.2004 15.9.2004 Xenical Roche Registration Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/071/001-006 17.9.2004

— Issuing 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 2.9.2004 Nobivac Piro Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Netherlands EU/2/04/046/001-003 6.9.2004 9.9.2004 Aivlosin ECO Animal Health Ltd, 78 Coombe Road, New Malden, Surrey KT3 4QS, United Kingdom EU/2/04/044/001 13.9.2004 13.9.2004 Previcox Merial SAS. 4 Chemin de Calquet, F-31300 Toulouse EU/2/04/045/001-004 15.9.2004

— 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 31.8.2004 DRAXXIN Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/03/041/001-005 2.9.2004

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