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Document 52005XC0826(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2005 to 31 July 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2005 to 31 July 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2005 to 31 July 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
OJ C 209, 26.8.2005, p. 3–6
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
26.8.2005 |
EN |
Official Journal of the European Union |
C 209/3 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2005 to 31 July 2005
(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))
(2005/C 209/03)
— Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93): 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 |
|
4.7.2005 |
Apidra |
Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main |
EU/1/04/285/001-028 |
6.7.2005 |
|
4.7.2005 |
Forcaltonin |
Unigene UK Limited, 63 High Road, Bushey Heath, Herts, WD2 1EE, United Kingdom |
EU/1/98/093/002 |
6.7.2005 |
|
4.7.2005 |
Trisenox |
Cell Therapeutics (UK) Ltd, 100 Pall Mall, London SW1Y 5HP, United Kingdom |
EU/1/02/204/001 |
6.7.2005 |
|
4.7.2005 |
Levemir |
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd |
EU/1/04/278/001-009 |
6.7.2005 |
|
4.7.2005 |
Zerene |
Wyeth Research (UK) Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
EU/1/99/099/001-006 |
6.7.2005 |
|
4.7.2005 |
Sonata |
Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
EU/1/99/102/001-008 |
6.7.2005 |
|
4.7.2005 |
Cymbalta |
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/04/296/001-006 |
6.7.2005 |
|
4.7.2005 |
Cymbalta |
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/04/296/001-006 |
6.7.2005 |
|
4.7.2005 |
Xeristar |
Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein |
EU/1/04/297/001-006 |
6.7.2005 |
|
4.7.2005 |
Xeristar |
Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein |
EU/1/04/297/001-006 |
6.7.2005 |
|
4.7.2005 |
Visudyne |
Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
EU/1/00/140/001 |
6.7.2005 |
|
4.7.2005 |
Xigris |
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/02/225/001-002 |
6.7.2005 |
|
7.7.2005 |
Invanz |
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/02/216/001-002 |
11.7.2005 |
|
7.7.2005 |
Arixtra |
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom |
EU/1/02/206/001-008 |
11.7.2005 |
|
7.7.2005 |
Quixidar |
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom |
EU/1/02/207/001-008 |
11.7.2005 |
|
7.7.2005 |
Cystagon |
Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense |
EU/1/97/039/001-004 |
11.7.2005 |
|
8.7.2005 |
Glivec |
Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
EU/1/01/198/001-013 |
12.7.2005 |
|
8.7.2005 |
Aranesp |
Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/01/185/001-056 |
12.7.2005 |
|
8.7.2005 |
Nespo |
Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano |
EU/1/01/184/001-056 |
12.7.2005 |
|
8.7.2005 |
Lyrica |
PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
EU/1/04/279/030-032 |
12.7.2005 |
|
8.7.2005 |
Fortovase |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/98/075/001-002 |
12.7.2005 |
|
8.7.2005 |
AVANDIA |
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom |
EU/1/00/137/001-012 |
12.7.2005 |
|
8.7.2005 |
NovoRapid |
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd |
EU/1/99/119/003 EU/1/99/119/005-007 EU/1/99/119/009-014 |
12.7.2005 |
|
8.7.2005 |
NeuroBloc |
Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland |
EU/1/00/166/001-003 |
13.7.2005 |
|
8.7.2005 |
Simulect |
Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
EU/1/98/084/001-002 |
12.7.2005 |
|
8.7.2005 |
Zevalin |
Schering AG, Müllerstrasse 170-178, D-13342 Berlin |
EU/1/03/264/001 |
12.7.2005 |
|
8.7.2005 |
Viread |
Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom |
EU/1/01/200/001 |
12.7.2005 |
|
8.7.2005 |
Keppra |
UCB SA, Allée de la recherche, 60, B-1070 Bruxelles/Researchdreef, 60, B-1070 Brussel |
EU/1/00/146/001-027 |
12.7.2005 |
|
8.7.2005 |
Lantus |
Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main |
EU/1/00/134/001-029 |
12.7.2005 |
|
8.7.2005 |
Optisulin |
Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main |
EU/1/00/133/001-008 |
12.7.2005 |
|
13.7.2005 |
NeoRecormon |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/97/031/001-003 EU/1/97/031/019-046 |
15.7.2005 |
|
22.7.2005 |
Enbrel |
Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
EU/1/99/126/001-011 |
26.7.2005 |
|
22.7.2005 |
KOGENATE Bayer |
Bayer AG, D-51368 Leverkusen |
EU/1/00/143/001-006 |
26.7.2005 |
|
27.7.2005 |
Vaniqa |
Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom |
EU/1/01/173/001-003 |
29.7.2005 |
|
27.7.2005 |
Infergen |
Yamanouchi Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, Nederland |
EU/1/98/087/001-003 |
29.7.2005 |
|
27.7.2005 |
Zevalin |
Schering AG, Müllerstrasse 170-178, D-13342 Berlin |
EU/1/03/264/001 |
29.7.2005 |
|
27.7.2005 |
Replagal |
TKT Europe AB, Rinkebyvägen 11B, S-182 36 Danderyd |
EU/1/01/189/001-006 |
29.7.2005 |
|
27.7.2005 |
Velcade |
Janssen-Cilag International NV, Turnhoutseweg, 30 B-2340 Beerse |
EU/1/04/274/001 |
29.7.2005 |
|
27.7.2005 |
AVANDIA |
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom |
EU/1/00/137/001-012 |
29.7.2005 |
|
27.7.2005 |
ReFacto |
Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
EU/1/99/103/001-004 |
29.7.2005 |
|
28.7.2005 |
Kineret |
Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/02/203/001-004 |
1.8.2005 |
— Issuing of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93): 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 |
|
8.7.2005 |
Equilis Prequenza |
Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/05/056/001-002 |
12.7.2005 |
|
8.7.2005 |
Equilis Prequenza Te |
Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/05/057/001-002 |
12.7.2005 |
|
8.7.2005 |
Equilis Te |
Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/05/055/001-002 |
12.7.2005 |
|
27.7.2005 |
Profender |
Bayer Healthcare AG, D-51368 Leverkusen |
EU/2/05/054/001-017 |
29.7.2005 |
— Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93): 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 |
|
7.7.2005 |
Neocolipor |
Merial, 29 avenue Tony Garnier, F-69007 Lyon |
EU/2/98/008/001-004 |
11.7.2005 |
|
8.7.2005 |
Ibaflin |
Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/00/022/001a-001b, 002a-002b, 003a-003b, 004a-004b, EU/2/00/022/005-017, |
12.7.2005 |
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 Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
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London E14 4HB |
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United Kingdom |
(1) OJ L 214 of 24.8.1993, p. 1.