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Document 52009XC0130(01)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2008 to 31 December 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 December 2008 to 31 December 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 December 2008 to 31 December 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 24, 30.1.2009, p. 8–13
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
30.1.2009 |
EN |
Official Journal of the European Union |
C 24/8 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2008 to 31 December 2008
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
(2009/C 24/06)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted
|
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 |
|||||
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1.12.2008 |
Irbesartan Krka |
Irbesartan |
|
EU/1/08/480/001-018 |
Film-coated tablet |
C09CA04 |
3.12.2008 |
|||||
|
1.12.2008 |
Vildagliptin/metformin hydrochloride Novartis |
Vildagliptin/metformin hydrochloride |
|
EU/1/08/484/001-018 |
Film-coated tablet |
A10BD08 |
3.12.2008 |
|||||
|
1.12.2008 |
Zomarist |
Vildagliptin/metformin hydrochloride |
|
EU/1/08/483/001-018 |
Film-coated tablet |
A10BD08 |
3.12.2008 |
|||||
|
2.12.2008 |
Kuvan |
Sapropterin dihydrochloride |
|
EU/1/08/481/001-003 |
Soluble tablet |
A16AX07 |
4.12.2008 |
|||||
|
17.12.2008 |
Vidaza |
Azacitidine |
|
EU/1/08/488/001 |
Powder for suspension for injection |
L01BC07 |
22.12.2008 |
|||||
|
18.12.2008 |
Pramipexole Teva |
Pramipexole |
|
EU/1/08/490/001-016 |
Tablet |
N04B C05 |
23.12.2008 |
— 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 |
|||||||
|
1.12.2008 |
Sustiva |
|
EU/1/99/110/001-009 |
3.12.2008 |
|||||||
|
2.12.2008 |
Axura |
|
EU/1/02/218/001-029 |
4.12.2008 |
|||||||
|
2.12.2008 |
Ebixa |
|
EU/1/02/219/001-049 |
4.12.2008 |
|||||||
|
2.12.2008 |
Herceptin |
|
EU/1/00/145/001 |
4.12.2008 |
|||||||
|
2.12.2008 |
Rebetol |
|
EU/1/99/107/001-005 |
4.12.2008 |
|||||||
|
4.12.2008 |
Xigris |
|
EU/1/02/225/001-002 |
9.12.2008 |
|||||||
|
4.12.2008 |
Visudyne |
|
EU/1/00/140/001 |
9.12.2008 |
|||||||
|
4.12.2008 |
Noxafil |
|
EU/1/05/320/001 |
9.12.2008 |
|||||||
|
4.12.2008 |
Ammonaps |
|
EU/1/99/120/001-004 |
10.12.2008 |
|||||||
|
5.12.2008 |
Optimark |
|
EU/1/07/398/001-014 |
9.12.2008 |
|||||||
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5.12.2008 |
ViraferonPeg |
|
EU/1/00/132/001-050 |
9.12.2008 |
|||||||
|
5.12.2008 |
Norvir |
|
EU/1/96/016/001 EU/1/96/016/003-004 |
9.12.2008 |
|||||||
|
5.12.2008 |
PegIntron |
|
EU/1/00/131/001-050 |
9.12.2008 |
|||||||
|
5.12.2008 |
MabCampath |
|
EU/1/01/193/001-002 |
9.12.2008 |
|||||||
|
12.12.2008 |
Mixtard |
|
EU/1/02/231/033-035 |
16.12.2008 |
|||||||
|
16.12.2008 |
Prezista |
|
EU/1/06/380/001 |
18.12.2008 |
|||||||
|
16.12.2008 |
Faslodex |
|
EU/1/03/269/001 |
18.12.2008 |
|||||||
|
16.12.2008 |
Somavert |
|
EU/1/02/240/001-004 |
18.12.2008 |
|||||||
|
17.12.2008 |
Temodal |
|
EU/1/98/096/001-012 |
22.12.2008 |
|||||||
|
17.12.2008 |
Fareston |
|
EU/1/96/004/001-002 |
22.12.2008 |
|||||||
|
17.12.2008 |
NovoNorm |
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EU/1/98/076/004-006 EU/1/98/076/011-013 EU/1/98/076/018-020 EU/1/98/076/022-024 |
22.12.2008 |
|||||||
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17.12.2008 |
Actrapid |
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EU/1/02/230/013-015 |
22.12.2008 |
|||||||
|
17.12.2008 |
Prandin |
|
EU/1/00/162/003-005 EU/1/00/162/009-011 EU/1/00/162/015-017 EU/1/00/162/019-021 |
22.12.2008 |
|||||||
|
17.12.2008 |
Avandia |
|
EU/1/00/137/002-018 |
22.12.2008 |
|||||||
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17.12.2008 |
Hepsera |
|
EU/1/03/251/001-002 |
22.12.2008 |
|||||||
|
17.12.2008 |
Exjade |
|
EU/1/06/356/001-009 |
22.12.2008 |
|||||||
|
17.12.2008 |
Avonex |
|
EU/1/97/033/002-004 |
22.12.2008 |
|||||||
|
17.12.2008 |
Actraphane |
|
EU/1/02/229/033-035 |
22.12.2008 |
|||||||
|
19.12.2008 |
Tysabri |
|
EU/1/06/346/001 |
23.12.2008 |
|||||||
|
22.12.2008 |
Telzir |
|
EU/1/04/282/001-002 |
24.12.2008 |
|||||||
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22.12.2008 |
Arixtra |
|
EU/1/02/206/001-020 |
24.12.2008 |
|||||||
|
22.12.2008 |
Lyrica |
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EU/1/04/279/001-043 |
24.12.2008 |
|||||||
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22.12.2008 |
Cholestagel |
|
EU/1/03/268/001-004 |
24.12.2008 |
|||||||
|
22.12.2008 |
Vectibix |
|
EU/1/07/423/001-003 |
24.12.2008 |
|||||||
|
22.12.2008 |
Prezista |
|
EU/1/06/380/001 |
24.12.2008 |
|||||||
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22.12.2008 |
Invanz |
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EU/1/02/216/001-002 |
24.12.2008 |
|||||||
|
22.12.2008 |
Cerezyme |
|
EU/1/97/053/001-005 |
24.12.2008 |
|||||||
|
22.12.2008 |
Atripla |
|
EU/1/07/430/001-002 |
5.1.2009 |
|||||||
|
22.12.2008 |
Revlimid |
|
EU/1/07/391/001-004 |
24.12.2008 |
|||||||
|
22.12.2008 |
Enbrel |
|
EU/1/99/126/001-018 |
24.12.2008 |
|||||||
|
22.12.2008 |
Truvada |
|
EU/1/04/305/001-002 |
24.12.2008 |
|||||||
|
22.12.2008 |
Evra |
|
EU/1/02/223/001-003 |
24.12.2008 |
|||||||
|
22.12.2008 |
Aptivus |
|
EU/1/05/315/001 |
29.12.2008 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Rejected
|
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 |
||||
|
8.12.2008 |
Xeristar |
|
EU/1/04/297/001-008 |
10.12.2008 |
||||
|
8.12.2008 |
Cymbalta |
|
EU/1/04/296/001-009 |
10.12.2008 |
— 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 |
|||
|
5.12.2008 |
Parareg |
|
EU/1/04/293/001-012 |
9.12.2008 |
|||
|
5.12.2008 |
Neupopeg |
|
EU/1/02/228/001-003 |
9.12.2008 |
|||
|
5.12.2008 |
Nespo |
|
EU/1/01/184/001-073 |
9.12.2008 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Accepted
|
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 |
|||||
|
9.12.2008 |
Acticam |
Meloxicam |
|
EU/2/08/088/001-003 |
Oral suspension |
QM01AC06 |
11.12.2008 |
|||||
|
EU/2/08/088/004 |
Solution for injection |
|||||||||||
|
16.12.2008 |
Onsior |
Robenacoxib |
|
EU/2/08/089/001-019 |
Tablet |
QM01AH91 |
18.12.2008 |
|||||
|
EU/2/08/089/020 |
Solution for injection |
— 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 |
|||||
|
5.12.2008 |
Locatim |
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EU/2/99/011/001 |
10.12.2008 |
|||||
|
9.12.2008 |
Flexicam |
|
EU/2/06/058/004 |
11.12.2008 |
|||||
|
16.12.2008 |
Equilis StrepE |
|
EU/2/04/043/001 |
18.12.2008 |
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 136, 30.4. 2004, p. 1.