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Document 52004XC1029(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 September 2004 to 15 October 2004(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 15. septembra 2004 do 15. oktobra 2004(Objavljeno na podlagi člena 12 oziroma člena 34 Uredbe Sveta (EGS) št. 2309/93)
Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 15. septembra 2004 do 15. oktobra 2004(Objavljeno na podlagi člena 12 oziroma člena 34 Uredbe Sveta (EGS) št. 2309/93)
UL C 266, 29.10.2004, p. 5–7
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
29.10.2004 |
SL |
Uradni list Evropske unije |
C 266/5 |
Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 15. septembra 2004 do 15. oktobra 2004
(Objavljeno na podlagi člena 12 oziroma člena 34 Uredbe Sveta (EGS) št. 2309/93 (1))
(2004/C 266/04)
Izdaja dovoljenja za promet (člen 12 Uredbe (EGS) št. 2309/93): odobrena
|
Datum odločbe |
Ime zdravila |
Imetnik dovoljenja za promet |
Številka vpisa v register Skupnosti |
Datum priglasitve |
|
20.9.2004 |
Angiox |
The Medicines Company UK Ltd, Suite B, Park House, 11 Milton Park, Abingdon, Oxfordshire OX14 4RS, United Kingdom |
EU/1/04/289/001 |
22.9.2004 |
|
20.9.2004 |
Alimta |
Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/04/290/001 |
22.9.2004 |
|
20.9.2004 |
Raptiva |
Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/04/291/001-002 |
22.9.2004 |
|
21.9.2004 |
Protelos |
Les Laboratoires Servier, 22, rue Garnier, F-92200 Neuilly sur-Seine |
EU/1/04/288/001-006 |
23.9.2004 |
|
21.9.2004 |
Osseor |
Les Laboratoires Servier, 22, rue Garnier, F-92200 Neuilly sur- Seine |
EU/1/04/287/001-006 |
23.9.2004 |
|
27.9.2004 |
Apidra |
Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main |
EU/1/04/285/001-020 |
29.9.2004 |
|
13.10.2004 |
Wilzin |
Orphan Europe SARL, Immeuble „Le Guillaumet“ F-92046 Paris-La-Défense |
EU/1/04/286/001-002 |
18.10.2004 |
Sprememba dovoljenja za promet (člen 12 Uredbe (EGS) št. 2309/93): odobrena
|
Datum odločbe |
Ime zdravila |
Imetnik dovoljenja za promet |
Številka vpisa v register Skupnosti |
Datum priglasitve |
|
20.9.2004 |
Remicade |
Centocor BV, Einsteinweg 101, 2333 CB Leiden, Nederland |
EU/1/99/116/001-003 |
22.9.2004 |
|
20.9.2004 |
Azomyr |
Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles |
EU/1/00/157/014-021 |
22.9.2004 |
|
20.9.2004 |
Aerius |
Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles |
EU/1/00/160/014-021 |
22.9.2004 |
|
20.9.2004 |
Neoclarityn |
Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles |
EU/1/00/161/014-021 |
22.9.2004 |
|
20.9.2004 |
Lantus |
Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main |
EU/1/00/134/008-011 EU/1/00/134/018-021 |
22.9.2004 |
|
20.9.2004 |
Velcade |
Millennium Pharmaceuticals, Ltd, Building 3, Chiswick Park, 566 Chiswick High Road, Chiswick, London, W4 5YA United Kingdom |
EU/1/04/274/001 |
22.9.2004 |
|
20.9.2004 |
Velcade |
Janssen-Cilag International NV, Turnhoutsewe 30, B-2340 Beerse |
EU/1/04/274/001 |
23.9.2004 |
|
20.9.2004 |
Ovitrelle |
Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/00/165/001-007 |
22.9.2004 |
|
21.9.2004 |
Carbaglu |
Orphan Europe, Immeuble „Le Guillaumet“, F-92046 Paris La Défense |
EU/1/02/246/001-002 |
23.9.2004 |
|
21.9.2004 |
KOGENATE Bayer |
Bayer AG, D-51368 Leverkusen |
EU/1/00/143/004-006 |
23.9.2004 |
|
23.9.2004 |
Remicade |
Centocor BV, Einsteinweg 101, 2333 CB Leiden, Nederland |
EU/1/99/116/001-003 |
27.9.2004 |
|
24.9.2004 |
Insuman |
Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main |
EU/1/97/030/065-084 |
29.9.2004 |
|
24.9.2004 |
InductOs |
Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
EU/1/02/226/001 |
28.9.2004 |
|
24.9.2004 |
Enbrel |
Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
EU/1/99/126/001-003 |
28.9.2004 |
|
27.9.2004 |
SonoVue |
Bracco International BV, Strawinskylaan 3051, 1077ZX Amsterdam, Nederland |
EU/1/01/177/001-002 |
29.9.2004 |
|
27.9.2004 |
Ceprotin |
Baxter AG, Industriesstrasse 67, A-1220 Vienna |
EU/1/01/190/001-002 |
29.9.2004 |
|
27.9.2004 |
Avonex |
Biogen Idec France, „Le Capitole“ 55, avenue des Champs Pierreux – F-92012 Nanterre Cedex |
EU/1/97/033/001-003 |
30.9.2004 |
|
13.10.2004 |
Revasc |
Canyon Pharmaceuticals Ltd, 20-22 Bedford Row - WC1R 4JS London - United Kingdom |
EU/1/97/043/001-002 |
19.10.2004 |
|
Aventis Pharma S.A., 20 Avenue Raymond Aron, F-92165 Antony Cedex |
18.10.2004 |
|||
|
13.10.2004 |
Arava |
Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main |
EU/1/99/118/001-010 |
18.10.2004 |
|
13.10.2004 |
Vaniqa |
Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom |
EU/1/01/173/001-003 |
18.10.2004 |
|
13.10.2004 |
NovoRapid |
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd |
EU/1/99/119/001-014 |
18.10.2004 |
|
13.10.2004 |
Levviax |
Aventis Pharma S.A., 20 Avenue Raymond Aron, F-92160 Antony |
EU/1/01/192/001-005 |
19.10.2004 |
|
15.10.2004 |
Ketek |
Aventis Pharma S.A., 20 Avenue Raymond Aron, F-92160 Antony |
EU/1/01/191/001-005 |
19.10.2004 |
|
15.10.2004 |
Viramune |
Boehringer Ingelheim International GmbH, Binger Strasse 173 - D-55216 Ingelheim am Rhein |
EU/1/97/055/001-002 |
19.10.2004 |
|
15.10.2004 |
Fuzeon |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/03/252/001-003 |
20.10.2004 |
|
15.10.2004 |
NovoRapid |
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd |
EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-014 |
19.10.2004 |
Preklic dovoljenja za promet (člen 12 Uredbe (EGS) št. 2309/93)
|
Datum odločbe |
Ime zdravila |
Imetnik dovoljenja za promet |
Številka vpisa v register Skupnosti |
Datum priglasitve |
|
28.9.2004 |
Ixense |
Takeda Europe R&D Centre Ltd, Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom |
EU/1/01/181/001-007 |
30.9.2004 |
(1) UL L 214, 24.8.1993, str. 1.