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Document 52005XC0624(01)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 May 2005 to 15 June 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 15 May 2005 to 15 June 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 15 May 2005 to 15 June 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
OJ C 153, 24.6.2005, p. 3–5
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
24.6.2005 |
EN |
Official Journal of the European Union |
C 153/3 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 May 2005 to 15 June 2005
(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) (1)
(2005/C 153/03)
— 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 |
|
18.5.2005 |
Bonviva |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/03/265/001-002 |
24.5.2005 |
|
23.5.2005 |
IntronA |
Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel |
EU/1/99/127/001-044 |
25.5.2005 |
|
23.5.2005 |
Viraferon |
Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel |
EU/1/99/128/001-037 |
25.5.2005 |
|
23.5.2005 |
Kentera |
Nicobrand Limited, 189 Casteroe Road, Coleraine, Northern Ireland BT51 3 RP |
EU/1/03/270/001-003 |
25.5.2005 |
|
23.5.2005 |
DepoCyte |
SkyePharma PLC, 105 Piccadilly, London W1V 9FN, United Kingdom |
EU/1/01/187/001 |
25.5.2005 |
|
25.5.2005 |
Invirase |
Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom |
EU/1/96/026/002 |
27.5.2005 |
|
25.5.2005 |
PegIntron |
Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel |
EU/1/00/131/001-050 |
27.5.2005 |
|
25.5.2005 |
ViraferonPeg |
Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel |
EU/1/00/132/001-050 |
27.5.2005 |
|
2.6.2005 |
Azopt |
Alcon Laboratories (UK) Ltd., Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UK, United Kingdom |
EU/1/00/129/001-003 |
6.6.2005 |
|
2.6.2005 |
Onsenal |
Pharmacia-Pfizer EEIG, Ramsgate Road, Sanwich, CT13 9NJ, United Kingdom |
EU/1/03/259/001-006 |
6.6.2005 |
|
2.6.2005 |
Glivec |
Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
EU/1/01/198/001-013 |
6.6.2005 |
|
3.6.2005 |
Zavesca |
Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/02/238/001 |
7.6.2005 |
|
3.6.2005 |
Ariclaim |
Boehringer Ingelheim International GmbH, Binger Straße 173, D-5216 Ingelheim am Rhein |
EU/1/04/283/001-006 |
7.6.2005 |
|
3.6.2005 |
Rebetol |
Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel |
EU/1/99/107/001-004 |
7.6.2005 |
|
3.6.2005 |
Ketek |
Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony |
EU/1/01/191/001-005 |
7.6.2005 |
|
3.6.2005 |
Levviax |
Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony |
EU/1/01/192/001-005 |
7.6.2005 |
|
3.6.2005 |
Temodal |
Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel |
EU/1/98/096/001-008 |
7.6.2005 |
|
3.6.2005 |
Valdyn |
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/02/244/001-024 |
7.6.2005 |
|
10.6.2005 |
Taxotere |
Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex |
EU/1/95/002/001-002 |
14.6.2005 |
|
10.6.2005 |
Viracept |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/97/054/001 EU/1/97/054/003-006 |
14.6.2005 |
|
10.6.2005 |
Azilect |
Teva Pharma GmbH, Kandelstraße 10, D-79199 Kirchzarten |
EU/1/04/304/001-007 |
14.6.2005 |
|
10.6.2005 |
Angiox |
The Medicines Company UK Ltd, Suite B, Park House, 11 Milton Park, Abingdon, Oxfordshire OX14 4RS, United Kingdom |
EU/1/04/289/001-002 |
14.6.2005 |
|
10.6.2005 |
Rayzon |
Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/02/210/001-008 |
14.6.2005 |
|
10.6.2005 |
Dynastat |
Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/02/209/001-008 |
14.6.2005 |
|
10.6.2005 |
TachoSil |
Nycomed Austria GmbH, St.-Peter-Straße 25, A-4020 Linz |
EU/1/04/277/001-004 |
14.6.2005 |
|
10.6.2005 |
Bextra |
Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/02/239/001-030 |
14.6.2005 |
|
10.6.2005 |
NovoMix 30 |
Novo Nordisk A/S, Novo Allé, DK-880 Bagsværd |
EU/1/00/142/004-005 EU/1/00/142/009-010 |
14.6.2005 |
|
10.6.2005 |
Protopy |
Fujisawa GmbH, Neumarkter Str. 61, D-81673 München |
EU/1/02/202/001-006 |
14.6.2005 |
|
10.6.2005 |
Protopic |
Fujisawa GmbH, Neumarkter Str. 61, D-81673 München |
EU/1/02/201/001-006 |
14.6.2005 |
|
10.6.2005 |
Xenical |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom |
EU/1/98/071/001-006 |
14.6.2005 |
|
10.6.2005 |
Avandia |
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom |
EU/1/00/137/001-012 |
14.6.2005 |
— 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 |
|
19.5.2005 |
Naxcel |
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/2/05/053/001 |
24.5.2005 |
— 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 |
|
26.5.2005 |
Econor |
Novartis Animal Health Austria GmbH, Biochemiestraße 10, A-250 Kundl |
EU/2/98/010/004-006 EU/2/98/010/017-018 EU/2/98/010/021-024 |
30.5.2005 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
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The European Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
|
London E14 4HB |
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United Kingdom |
(1) OJ L 214 of 24.8.1993, p. 1.