EN Official Journal of the European Union C 215/7

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004

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

(2004/C 215/05)

— 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 29.7.2004 Pedea Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense, France EU/1/04/284/001 2.8.2004 11.8.2004 Yentreve Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/280/001-006. 13.8.2004 11.8.2004 Ariclaim Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/04/283/001-006 13.8.2004

— 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 19.7.2004 Reyataz Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom EU/1/03/267/001-007 21.07.2004 19.7.2004 Humira Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/256/001-006 21.07.2004 19.7.2004 Trudexa Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/257/001-006 21.07.2004 19.7.2004 Nyracta SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/139/001-012 21.07.2004 19.7.2004 Avandia SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/137/001-012 21.07.2004 19.7.2004 Venvia SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/138/001-012 21.07.2004 20.7.2004 Rebif Serono Europe Ltd., 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063/001-006 23.07.2004 20.7.2004 Replagal TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige EU/1/01/189/001-003 23.07.2004 20.7.2004 Refacto Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/103/001-004 23.07.2004 22.7.2004 Mirapexin Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland Pfizer Enterprises SARL, 6, Circuit de la Foire Internationale, 1347 Luxembourg, Grand-Duché du Luxembourg EU/1/97/051/001-006 EU/1/97/051/009-012 26.07.2004 23.7.2004 Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-003 27.07.2004 23.7.2004 Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-003 27.07.2004 29.7.2004 ReFacto Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/103/001-004 2.8.2004 29.7.2004 Replagal TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige EU/1/01/189/004-006 2.8.2004 2.8.2004 Procomvax Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France EU/1/99/104/001 4.8.2004 2.8.2004 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France EU/1/98/086/001-020 4.8.2004 2.8.2004 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France EU/1/97/046/001-030 4.8.2004 2.8.2004 Karvezide Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom EU/1/98/085/001-020 4.8.2004 2.8.2004 Karvea Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom EU/1/97/049/001-030 4.8.2004 2.8.2004 MabThera Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/067/001-002 4.8.2004 2.8.2004 Plavix Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France EU/1/98/069/001a-001b, EU/1/98/069/002a-002b, EU/1/98/069/003a-003b, EU/1/98/069/004a-004b 4.8.2004 2.8.2004 Iscover Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom EU/1/98/070/001a-001b, EU/1/98/070/002a-002b, EU/1/98/070/003a-003b, EU/1/98/070/004a-004b 4.8.2004 2.8.2004 Prevenar Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15 - 1348 Louvain-La-Neuve - Belgique EU/1/00/167/001-007 4.8.2004 2.8.2004 Actrapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/230/001-017 4.8.2004 2.8.2004 Mixtard Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/231/001-037 4.8.2004 2.8.2004 Insulatard Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/233/001-017 4.8.2004 2.8.2004 Velosulin Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/232/001-003 4.8.2004 2.8.2004 Protaphane Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/234/001-017 4.8.2004 2.8.2004 Puregon Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland EU/1/96/008/038-039 4.8.2004 2.8.2004 Puregon, Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland EU/1/96/008/040-041 4.8.2004 2.8.2004 Viread Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/01/200/001 4.8.2004 2.8.2004 Emtriva Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/03/261/001-003 4.8.2004 2.8.2004 Actraphane Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/229/001-037 4.8.2004 2.8.2004 Norvir Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom EU/1/96/016/001 and EU/1/96/016/003 4.8.2004 2.8.2004 Starlix Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/174/001-021 4.8.2004 2.8.2004 Cellcept Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/96/005/001-006 4.8.2004 2.8.2004 Protopy Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, Deutschland EU/1/02/202/001-007 4.8.2004 2.8.2004 Inomax INO Therapeutics AB, SE-181 81 Lidingö, Sverige EU/1/01/194/001-002 4.8.2004 2.8.2004 Trazec Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/175/001-021 4.8.2004 4.8.2004 Insuman Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, Deutschland EU/1/97/030/030, EU/1/97/030/035, EU/1/97/030/040, EU/1/97/030/045, EU/1/97/030/050, EU/1/97/030/055-064 6.8.2004 4.8.2004 Somavert Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/240/001-004 6.8.2004 9.8.2004 Fabrazyme Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/01/188/001-006 12.8.2004 11.8.2004 Vfend Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212/001-026 13.8.2004 12.8.2004 Infergen Yamanouchi Europe B.V., Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/98/087/001-003 16.8.2004 12.8.2004 Optison Amersham Health AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, 0401 Oslo, Norway EU/1/98/065/001-002 16.8.2004

— 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 23.07.2004 Eurifel RCP FeL V Merial, 29 avenue Tony Garnier, 69007 Lyon, France EU/2/02/031/001-002 27.07.2004 29-07-2004 Virbagen Omega VIRBAC S.A., 1ere Avenue 2065 m L.I.D. - 06516 Carros - France EU/2/01/030/001-002 02-08-2004 11-08-2004 Porcilis Porcoli Intervet International B.V. (NL), Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/96/001/009-010 13-08-2004

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 Agency for the Evaluation of Medicinal products 7, Westferry Circus, Canary Wharf UK - LONDON E14 4HB

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