EN Official Journal of the European Union C 194/2

Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 June 2004 to 15 July 2004

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

(2004/C 194/02)

— 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 29.6.2004 Erbitux Merck KgaA Frankfurter Straße 250 D-64293 Darmstadt EU/1/04/281/001 1.7.2004 6.7.2004 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/04/279/001-025 8.7.2004 12.7.2004 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 14.7.2004

— 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 17.6.2004 GONAL-f Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/95/001/005-008 EU/1/95/001/013-020 21.6.2004 17.6.2004 Beromun Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/99/097/001 21.6.2004 17.6.2004 Tractocile Ferring AB Soldattorpsvägen 5 Box 30047 S-200 61 Limhamn EU/1/99/124/001-002 21.6.2004 17.6.2004 Tritanrix HepB GlaxoSmithKline Biologicals sa Rue de l'Institut 89 B-1330 Rixensart EU/1/96/014/001-003 21.6.2004 23.6.2004 Emtriva Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/03/261/001-003 25.6.2004 23.6.2004 Kogenate Bayer Bayer AG D-51368 Leverkusen EU/1/00/143/001-003 25.6.2004 24.6.2004 Helixate NexGen Bayer AG D-51368 Leverkusen EU/1/00/144/001-003 28.6.2004 6.7.2004 Ammonaps Orphan Europe, Immeuble ‘Le Guillaumet’ F-92046 Paris-La Défense EU/1/99/120/001-004 8.7.2004 6.7.2004 Cialis Lilly ICOS Limited 25 New Street Square London EC4A 3LN United Kingdom EU/1/02/237/001-004 8.7.2004 7.7.2004 Novomix 30 Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/00/142/004-005 EU/1/00/142/007-010 12.7.2004 12.7.2004 Betaferon Schering AG Pharma D-13342 Berlin EU/1/95/003/001-004 14.7.2004 13.7.2004 Aldurazyme Genzyme Europe BV Gooimeer 10 1411 DD Naarden Nederland EU/1/03/253/001-003 15.7.2004 13.7.2004 Viramune Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-002 15.7.2004 13.7.2004 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/03/258/001-006 15.7.2004 13.7.2004 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main EU/1/02/218/001-011 15.7.2004 13.7.2004 Optisulin Aventis Pharma Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/133/001-008 15.7.2004 13.7.2004 Aldara 3M Santé Boulevard de l'Oise F-95029 Cergy Pontoise Cedex EU/1/98/080/001 15.7.2004 13.7.2004 Sustiva Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom EU/1/99/110/001-009/ 15.7.2004 13.7.2004 Lantus Aventis Pharma Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/134/001-021 15.7.2004 13.7.2004 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/001-009 15.7.2004 13.7.2004 Keppra UCB SA Allée de la recherche 60 B-1070 Bruxelles / Researchdreef, 60 B-1070 Brussel EU/1/00/146/001-027 16.7.2004 13.7.2004 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 15.7.2004 13.7.2004 Ebixa H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby EU/1/02/219/001-013 15.7.2004 13.7.2004 Zyprexa Velotab Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/99/125/001-004 15.7.2004

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

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 13.7.2004 Taluvian Abbott SpA Campoverde di Aprilia I-04010 Latina EU/1/01/182/001-010 15.7.2004

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