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Změna registrace (článek 12 nařízení Rady (EHS) č. 2309/93
(1)
) Přijato
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Datum rozhodnutí
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Název léčivého přípravku
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Držitel registrace
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Číslo zápisu do registru Společenství
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Datum oznámení
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19.7.2004
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Reyataz
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Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom
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EU/1/03/267/001-007
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21.7.2004
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19.7.2004
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Humira
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Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom
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EU/1/03/256/001-006
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21.7.2004
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19.7.2004
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Trudexa
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Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom
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EU/1/03/257/001-006
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21.7.2004
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19.7.2004
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Nyracta
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SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex,TW8 9GS United Kingdom
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EU/1/00/139/001-012
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21.7.2004
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19.7.2004
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Avandia
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SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex,TW8 9GS United Kingdom
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EU/1/00/137/001-012
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21.7.2004
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19.7.2004
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Venvia
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SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex,TW8 9GS United Kingdom
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EU/1/00/138/001-012
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21.7.2004
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20.7.2004
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Rebif
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Serono Europe Ltd., 56, Marsh Wall, London E14 9TP, United Kingdom
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EU/1/98/063/001-006
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23.7.2004
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20.7.2004
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Replagal
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TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige
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EU/1/01/189/001-003
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23.7.2004
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20.7.2004
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Refacto
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Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom
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EU/1/99/103/001-004
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23.7.2004
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22.7.2004
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Mirapexin
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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
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EU/1/97/051/001-006 EU/1/97/051/009-012
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26.7.2004
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23.7.2004
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Enbrel
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Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom
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EU/1/99/126/001-003
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27.7.2004
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23.7.2004
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Enbrel
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Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom
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EU/1/99/126/001-003
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27.7.2004
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29.7.2004
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ReFacto
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Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom
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EU/1/99/103/001-004
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2.8.2004
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29.7.2004
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Replagal
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TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige
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EU/1/01/189/004-006
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2.8.2004
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2.8.2004
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Procomvax
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Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France
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EU/1/99/104/001
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4.8.2004
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2.8.2004
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CoAprovel
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Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France
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EU/1/98/086/001-020
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4.8.2004
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2.8.2004
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Aprovel
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Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France
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EU/1/97/046/001-030
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4.8.2004
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2.8.2004
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Karvezide
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Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom
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EU/1/98/085/001-020
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4.8.2004
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2.8.2004
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Karvea
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Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom
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EU/1/97/049/001-030
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4.8.2004
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2.8.2004
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MabThera
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Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom
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EU/1/98/067/001-002
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4.8.2004
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2.8.2004
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Plavix
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Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France
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EU/1/98/069/001a-001b, EU/1/98/069/002a-002b, EU/1/98/069/003a-003b, EU/1/98/069/004a-004b
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4.8.2004
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2.8.2004
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Iscover
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Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom
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EU/1/98/070/001a-001b, EU/1/98/070/002a-002b, EU/1/98/070/003a-003b, EU/1/98/070/004a-004b
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4.8.2004
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2.8.2004
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Prevenar
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Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15 - 1348 Louvain-La-Neuve - Belgique
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EU/1/00/167/001-007
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4.8.2004
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2.8.2004
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Actrapid
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Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
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EU/1/02/230/001-017
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4.8.2004
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2.8.2004
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Mixtard
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Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
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EU/1/02/231/001-037
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4.8.2004
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2.8.2004
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Insulatard
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Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
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EU/1/02/233/001-017
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4.8.2004
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2.8.2004
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Velosulin
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Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
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EU/1/02/232/001-003
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4.8.2004
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2.8.2004
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Protaphane
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Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
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EU/1/02/234/001-017
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4.8.2004
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2.8.2004
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Puregon
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Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland
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EU/1/96/008/038-039
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4.8.2004
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2.8.2004
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Puregon,
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Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland
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EU/1/96/008/040-041
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4.8.2004
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2.8.2004
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Viread
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Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom
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EU/1/01/200/001
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4.8.2004
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2.8.2004
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Emtriva
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Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom
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EU/1/03/261/001-003
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4.8.2004
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2.8.2004
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Actraphane
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Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
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EU/1/02/229/001-037
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4.8.2004
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2.8.2004
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Norvir
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Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom
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EU/1/96/016/001 and EU/1/96/016/003
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4.8.2004
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2.8.2004
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Starlix
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Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom
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EU/1/01/174/001-021
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4.8.2004
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2.8.2004
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Cellcept
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Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom
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EU/1/96/005/001-006
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4.8.2004
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2.8.2004
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Protopy
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Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, Deutschland
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EU/1/02/202/001-007
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4.8.2004
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2.8.2004
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Inomax
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INO Therapeutics AB, SE-181 81 Lidingö, Sverige
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EU/1/01/194/001-002
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4.8.2004
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2.8.2004
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Trazec
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Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom
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EU/1/01/175/001-021
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4.8.2004
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4.8.2004
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Insuman
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Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, Deutschland
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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
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6.8.2004
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4.8.2004
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Somavert
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Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
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EU/1/02/240/001-004
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6.8.2004
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9.8.2004
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Fabrazyme
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Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland
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EU/1/01/188/001-006
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12.8.2004
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11.8.2004
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Vfend
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Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
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EU/1/02/212/001-026
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13.8.2004
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12.8.2004
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Infergen
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Yamanouchi Europe B.V., Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland
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EU/1/98/087/001-003
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16.8.2004
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12.8.2004
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Optison
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Amersham Health AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, 0401 Oslo, Norway
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EU/1/98/065/001-002
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16.8.2004
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