EN Official Journal of the European Union C 75/11

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

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

(2005/C 75/06)

— 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 17.2.2005 Quintanrix GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, B-1330 Rixensart EU/1/04/301/001-005 21.2.2005 21.2.2005 Truvada Gilead Sciences International Limited, Granta Park Abington Cambridge CB1 6GT United Kingdom EU/1/04/305/001 24.2.2005 21.2.2005 Orfadin Swedish Orphan International AB, Drottninggatan 98, S-111 60 Stockholm EU/1/04/303/001-003 24.2.2005 21.2.2005 Azilect Teva Pharma GmbH, Kandelstrasse 10, D-79199 Kirchzarten EU/1/04/304/001-007 24.2.2005 21.2.2005 Prialt Elan Pharma International Ltd, WIL House, Shannon Business Park, Shannon, County Clare, Ireland EU/1/04/302/001-003 24.2.2005 10.3.2005 Zonegran Eisai Limited, 3, Shortlands, London W6 8EE United Kingdom EU/1/04/307/001-004 14.3.2005

— 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 17.2.2005 Caelyx Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles – Stallestraat, 73 – B-1180 Brussel EU/1/96/011/001-004 21.2.2005 21.2.2005 Reyataz Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom EU/1/03/267/001-005 4.3.2005 23.2.2005 Pegasys Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/02/221/001-010 25.2.2005 23.2.2005 Tamiflu Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/02/222/001-002 25.2.2005 23.2.2005 Thyrogen Genzyme Europe BV, Gooimeer 10, Naarden 1411 DD, Nederland EU/1/99/122/001-002 25.2.2005 23.2.2005 Onsenal Pharmacia-Pfizer EEIG, Ramsgate Road, Sanwich, CT13 9NJ, United Kingdom EU/1/03/259/001-006 25.2.2005 28.2.2005 DaTSCAN Amersham plc, Amersham Place, Little Chalfont, Bucks, United Kingdom EU/1/00/135/045-056 2.3.2005 28.2.2005 Nespo Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano EU/1/01/184/045-056 2.3.2005 28.2.2005 Aranesp Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland EU/1/01/185/045-056 2.3.2005 28.2.2005 NeuroBloc Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland EU/1/00/166/001-003 3.3.2005 3.3.2005 Replagal TKT Europe AB, Rinkebyvägen 11B, S-182 36 Danderyd EU/1/01/189/001-006 7.3.2005 3.3.2005 Emtriva Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/03/261/001-003 7.3.2005 3.3.2005 Fabrazyme Genzyme Europe BV, Gooimeer 10, Naarden 1411 DD, Nederland EU/1/01/188/001-006 7.3.2005 3.3.2005 Orgalutran NV Organon, PO Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland EU/1/00/130/001-002 7.3.2005 7.3.2005 Ceprotin Baxter AG, Industriesstrasse 67, A-1220 Vienna EU/1/01/190/001-002 9.3.2005 7.3.2005 Ventavis Schering AG, Müllerstrasse 170-178, D-13342 Berlin EU/1/03/255/001-003 9.3.2005 7.3.2005 Mabthera Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/067/001-002 9.3.2005 7.3.2005 Ketek Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony EU/1/01/191/001-005 9.3.2005 7.3.2005 Levviax Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony EU/1/01/192/001-005 9.3.2005 7.3.2005 Stocrin Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111/001-009 9.3.2005 7.3.2005 Sustiva Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom EU/1/99/110/001-009 9.3.2005 7.3.2005 Comtess Orion Corporation, Orionintie 1, FIN-02200 Espoo EU/1/98/082/001-004 9.3.2005 7.3.2005 Comtan Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/081/001-004 9.3.2005 7.3.2005 Viread Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/01/200/001 9.3.2005 10.3.2005 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-005 14.3.2005 10.3.2005 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-005 14.3.2005 10.3.2005 Gonal-f Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/95/001/033-035 14.3.2005

— 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 23.2.2005 Purevax RCPCh FeLV Merial, 29 Avenue Tony Garnier, F-69007 Lyon EU/2/04/047/001-002 25.2.2005 23.2.2005 Purevax RCP FeLV Merial, 29 Avenue Tony Garnier, F-69007 Lyon EU/2/04/048/001-002 25.2.2005 23.2.2005 Purevax RCCh Merial, 29 Avenue Tony Garnier, F-69007 Lyon EU/2/04/049/001-002 25.2.2005 23.2.2005 Purevax RCPCh Merial, 29 Avenue Tony Garnier, F-69007 Lyon EU/2/04/050/001-002 25.2.2005 23.2.2005 Purevax RC Merial, 29 Avenue Tony Garnier, F-69007 Lyon EU/2/04/051/001-002 25.2.2005 23.2.2005 Purevax RCP Merial, 29 Avenue Tony Garnier, F-69007 Lyon EU/2/04/052/001-002 25.2.2005

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