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Document 52008XC0425(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
OJ C 104, 25.4.2008, p. 7–11
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
25.4.2008 |
EN |
Official Journal of the European Union |
C 104/7 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 2008
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
(2008/C 104/05)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|||
|
18.3.2008 |
Pradaxa |
dabigatran etexilate mesilate |
|
EU/1/08/442/001-008 |
Capsule, hard |
B01AE07 |
20.3.2008 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
|||||||
|
3.3.2008 |
Noxafil |
|
EU/1/05/320/001 |
5.3.2008 |
|||||||
|
3.3.2008 |
Posacozanole SP |
|
EU/1/05/321/001 |
5.3.2008 |
|||||||
|
3.3.2008 |
AVANDIA |
|
EU/1/00/137/002-018 |
5.3.2008 |
|||||||
|
3.3.2008 |
Avandamet |
|
EU/1/03/258/001-022 |
5.3.2008 |
|||||||
|
3.3.2008 |
Avaglim |
|
EU/1/06/349/001-010 |
5.3.2008 |
|||||||
|
3.3.2008 |
Avonex |
|
EU/1/97/033/002-004 |
5.3.2008 |
|||||||
|
5.3.2008 |
MIRCERA |
|
EU/1/07/400/001-016 |
7.3.2008 |
|||||||
|
5.3.2008 |
Replagal |
|
EU/1/01/189/001-006 |
7.3.2008 |
|||||||
|
5.3.2008 |
Cholestagel |
|
EU/1/03/268/001-003 |
7.3.2008 |
|||||||
|
11.3.2008 |
Helicobacter Test INFAI |
|
EU/1/97/045/001-004 |
13.3.2008 |
|||||||
|
17.3.2008 |
Vivanza |
|
EU/1/03/249/001-012 |
19.3.2008 |
|||||||
|
17.3.2008 |
Visudyne |
|
EU/1/00/140/001 |
19.3.2008 |
|||||||
|
17.3.2008 |
Cialis |
|
EU/1/02/237/001-008 |
19.3.2008 |
|||||||
|
17.3.2008 |
Levitra |
|
EU/1/03/248/001-012 |
19.3.2008 |
|||||||
|
17.3.2008 |
Mimpara |
|
EU/1/04/292/001-012 |
19.3.2008 |
|||||||
|
17.3.2008 |
Parareg |
|
EU/1/04/293/001-012 |
19.3.2008 |
|||||||
|
17.3.2008 |
Revatio |
|
EU/1/05/318/001 |
19.3.2008 |
|||||||
|
17.3.2008 |
Viagra |
|
EU/1/98/077/002-004 EU/1/98/077/006-008 EU/1/98/077/010-015 |
19.3.2008 |
|||||||
|
18.3.2008 |
Omnitrope |
|
EU/1/06/332/001-009 |
20.3.2008 |
|||||||
|
18.3.2008 |
Zavesca |
|
EU/1/02/238/001 |
20.3.2008 |
|||||||
|
18.3.2008 |
Hycamtin |
|
EU/1/96/027/006-007 |
20.3.2008 |
|||||||
|
18.3.2008 |
Kaletra |
|
EU/1/01/172/006 |
20.3.2008 |
|||||||
|
18.3.2008 |
Hepsera |
|
EU/1/03/251/001-002 |
20.3.2008 |
|||||||
|
18.3.2008 |
Revlimid |
|
EU/1/07/391/001-004 |
20.3.2008 |
|||||||
|
19.3.2008 |
Arixtra |
|
EU/1/02/206/001-020 |
26.3.2008 |
|||||||
|
27.3.2008 |
MicardisPlus |
|
EU/1/02/213/017-023 |
31.3.2008 |
|||||||
|
27.3.2008 |
Kinzalkomb |
|
EU/1/02/214/011-015 |
31.3.2008 |
|||||||
|
27.3.2008 |
Tygacil |
|
EU/1/06/336/001 |
31.3.2008 |
|||||||
|
27.3.2008 |
Aptivus |
|
EU/1/05/315/001 |
31.3.2008 |
|||||||
|
27.3.2008 |
Norvir |
|
EU/1/96/016/001 EU/1/96/016/003-004 |
31.3.2008 |
|||||||
|
27.3.2008 |
Lyrica |
|
EU/1/04/279/001-043 |
31.3.2008 |
|||||||
|
27.3.2008 |
Xeloda |
|
EU/1/00/163/001-002 |
31.3.2008 |
|||||||
|
27.3.2008 |
Optimark |
|
EU/1/07/398/001-014 |
31.3.2008 |
|||||||
|
31.3.2008 |
Neoclarityn |
|
EU/1/00/161/001-067 |
2.4.2008 |
|||||||
|
31.3.2008 |
Azomyr |
|
EU/1/00/157/001-067 |
2.4.2008 |
|||||||
|
31.3.2008 |
Xigris |
|
EU/1/02/225/001-002 |
2.4.2008 |
|||||||
|
31.3.2008 |
DuoTrav |
|
EU/1/06/338/001-003 |
2.4.2008 |
|||||||
|
31.3.2008 |
Optisulin |
|
EU/1/00/133/001-008 |
2.4.2008 |
|||||||
|
31.3.2008 |
Abilify |
|
EU/1/04/276/001-036 |
2.4.2008 |
|||||||
|
31.3.2008 |
Zonegran |
|
EU/1/04/307/001-013 |
2.4.2008 |
|||||||
|
31.3.2008 |
Aerius |
|
EU/1/00/160/001-069 |
2.4.2008 |
|||||||
|
31.3.2008 |
Tandemact |
|
EU/1/06/366/017-022 |
2.4.2008 |
— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)
|
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 |
|||||
|
11.3.2008 |
Quixidar |
|
EU/1/02/207/001-020 |
13.3.2008 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
|||||
|
5.3.2008 |
SevoFlo |
|
EU/2/02/035/001-007 |
7.3.2008 |
|||||
|
11.3.2008 |
Neocolipor |
|
EU/2/98/008/001-004 |
13.3.2008 |
|||||
|
18.3.2008 |
Stronghold |
|
EU/2/99/014/001-012 |
20.3.2008 |
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 |
|
United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.