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Änderung einer Zulassung (Artikel 12 der Verordnung (EWG) Nr. 2309/93 des Rates ( 1 ) ) Annahme Datum der Entscheidung Bezeichnung des Arzneimittels Zulassungsinhaber Registriernummer im Gemeinschaftsverzeichnis Datum der Mitteilung 19.07.2004 Reyataz Bristol — Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom EU/1/03/267/001-007 21.07.2004 19.07.2004 Humira Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/256/001-006 21.07.2004 19.07.2004 Trudexa Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/257/001-006 21.07.2004 19.07.2004 Nyracta SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex,TW8 9GS United Kingdom EU/1/00/139/001-012 21.07.2004 19.07.2004 Avandia SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex,TW8 9GS United Kingdom EU/1/00/137/001-012 21.07.2004 19.07.2004 Venvia SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex,TW8 9GS United Kingdom EU/1/00/138/001-012 21.07.2004 20.07.2004 Rebif Serono Europe Ltd, 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063/001-006 23.07.2004 20.07.2004 Replagal TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige EU/1/01/189/001-003 23.07.2004 20.07.2004 Refacto Wyeth Europa Ltd, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/103/001-004 23.07.2004 22.07.2004 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 23.07.2004 Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-003 27.07.2004 23.07.2004 Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-003 27.07.2004 29-07-2004 ReFacto Wyeth Europa Ltd, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/103/001-004 02-08-2004 29-07-2004 Replagal TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige EU/1/01/189/004-006 02-08-2004 02-08-2004 Procomvax Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France EU/1/99/104/001 04-08-2004 02-08-2004 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France — 75013 Paris, France EU/1/98/086/001-020 04-08-2004 02-08-2004 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France — 75013 Paris, France EU/1/97/046/001-030 04-08-2004 02-08-2004 Karvezide Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA — United Kingdom EU/1/98/085/001-020 04-08-2004 02-08-2004 Karvea Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA — United Kingdom EU/1/97/049/001-030 04-08-2004 02-08-2004 MabThera Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/067/001-002 04-08-2004 02-08-2004 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 04-08-2004 02-08-2004 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 04-08-2004 02-08-2004 Prevenar Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15-1348 Louvain-La-Neuve — Belgique EU/1/00/167/001-007 04-08-2004 02-08-2004 Actrapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/230/001-017 04-08-2004 02-08-2004 Mixtard Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/231/001-037 04-08-2004 02-08-2004 Insulatard Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/233/001-017 04-08-2004 02-08-2004 Velosulin Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/232/001-003 04-08-2004 02-08-2004 Protaphane Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/234/001-017 04-08-2004 02-08-2004 Puregon Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland EU/1/96/008/038-039 04-08-2004 02-08-2004 Puregon Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland EU/1/96/008/040-041 04-08-2004 02-08-2004 Viread Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/01/200/001 04-08-2004 02-08-2004 Emtriva Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/03/261/001-003 04-08-2004 02-08-2004 Actraphane Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/229/001-037 04-08-2004 02-08-2004 Norvir Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom EU/1/96/016/001 und EU/1/96/016/003 04-08-2004 02-08-2004 Starlix Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/174/001-021 04-08-2004 02-08-2004 Cellcept Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/96/005/001-006 04-08-2004 02-08-2004 Protopy Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, Deutschland EU/1/02/202/001-007 04-08-2004 02-08-2004 Inomax INO Therapeutics AB, SE-181 81 Lidingö, Sverige EU/1/01/194/001-002 04-08-2004 02-08-2004 Trazec Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/175/001-021 04-08-2004 04-08-2004 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 06-08-2004 04-08-2004 Somavert Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/240/001-004 06-08-2004 09-08-2004 Fabrazyme Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/01/188/001-006 12-08-2004 11-08-2004 Vfend Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212/001-026 13-08-2004 12-08-2004 Infergen Yamanouchi Europe B.V., Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/98/087/001-003 16-08-2004 12-08-2004 Optison Amersham Health AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, 0401 Oslo, Norway EU/1/98/065/001-002 16-08-2004