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Forgalombahozatali engedély módosítása (2309/93/EGK ( 1 ) tanácsi rendelet 12. cikk) – Elfogadva Határozat dátuma Gyógyszer- készítmény neve Forgalombahozatali engedély jogosultja Gyógyszerkészítmény száma a Közösségi nyilvántartásban Értesítés dátuma 2004.7.19. Reyataz Bristol-Myers Squibb Pharma EEIG, 141–149 Staines Road, Hounslow TW3 3JA, United Kingdom EU/1/03/267/001-007 2004.7.21. 2004.7.19. Humira Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/256/001-006 2004.7.21. 2004.7.19. Trudexa Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/257/001-006 2004.7.21. 2004.7.19. Nyracta SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/00/139/001-012 2004.7.21. 2004.7.19. Avandia SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/00/137/001-012 2004.7.21. 2004.7.19. Venvia SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/00/138/001-012 2004.7.21. 2004.7.20. Rebif Serono Europe Ltd., 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063/001-006 2004.7.23. 2004.7.20. Replagal TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige EU/1/01/189/001-003 2004.7.23. 2004.7.20. Refacto Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom EU/1/99/103/001-004 2004.7.23. 2004.7.22. 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 2004.7.26. 2004.7.23. Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom EU/1/99/126/001-003 2004.7.27. 2004.7.23. Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom EU/1/99/126/001-003 2004.7.27. 2004.7.29. ReFacto Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom EU/1/99/103/001-004 2004.8.2. 2004.7.29. Replagal TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige EU/1/01/189/004-006 2004.8.2. 2004.8.2. Procomvax Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France EU/1/99/104/001 2004.8.4. 2004.8.2. CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France – 75013 Paris, France EU/1/98/086/001-020 2004.8.4. 2004.8.2. Aprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France – 75013 Paris, France EU/1/97/046/001-030 2004.8.4. 2004.8.2. Karvezide Bristol-Myers Squibb Pharma EEIG, 141–149 Staines Road, Hounslow TW3 3JA – United Kingdom EU/1/98/085/001-020 2004.8.4. 2004.8.2. Karvea Bristol-Myers Squibb Pharma EEIG, 141–149 Staines Road, Hounslow TW3 3JA – United Kingdom EU/1/97/049/001-030 2004.8.4. 2004.8.2. MabThera Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/067/001-002 2004.8.4. 2004.8.2. 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 2004.8.4. 2004.8.2. 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 2004.8.4. 2004.8.2. Prevenar WyethLederle Vaccines S.A., Rue du Bosquet, 15 – 1348 Louvain-La-Neuve – Belgique EU/1/00/167/001-007 2004.8.4. 2004.8.2. Actrapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/230/001-017 2004.8.4. 2004.8.2. Mixtard Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/231/001-037 2004.8.4. 2004.8.2. Insulatard Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/233/001-017 2004.8.4. 2004.8.2. Velosulin Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/232/001-003 2004.8.4. 2004.8.2. Protaphane Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/234/001-017 2004.8.4. 2004.8.2. Puregon Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland EU/1/96/008/038-039 2004.8.4. 2004.8.2. Puregon Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland EU/1/96/008/040-041 2004.8.4. 2004.8.2. Viread Gilead Sciences International Limited, Cambridge CB1 6GT, United Kingdom EU/1/01/200/001 2004.8.4. 2004.8.2. Emtriva Gilead Sciences International Limited, Cambridge CB1 6GT, United Kingdom EU/1/03/261/001-003 2004.8.4. 2004.8.2. Actraphane Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark EU/1/02/229/001-037 2004.8.4. 2004.8.2. Norvir Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/96/016/001 and EU/1/96/016/003 2004.8.4. 2004.8.2. Starlix Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/174/001-021 2004.8.4. 2004.8.2. Cellcept Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/96/005/001-006 2004.8.4. 2004.8.2. Protopy Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, Deutschland EU/1/02/202/001-007 2004.8.4. 2004.8.2. Inomax INO Therapeutics AB, SE-181 81 Lidingö, Sverige EU/1/01/194/001-002 2004.8.4. 2004.8.2. Trazec Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/175/001-021 2004.8.4. 2004.8.4. 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 2004.8.6. 2004.8.4. Somavert Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/240/001-004 2004.8.6. 2004.8.9. Fabrazyme Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/01/188/001-006 2004.8.12. 2004.8.11. Vfend Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212/001-026 2004.8.13. 2004.8.12. Infergen Yamanouchi Europe B.V., Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/98/087/001-003 2004.8.16. 2004.8.12. Optison Amersham Health AS, Nycoveien 1–2, P.O. Box 4220 Nydalen, 0401 Oslo, Norway EU/1/98/065/001-002 2004.8.16.