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Document 52007XC0525(01)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 2007 (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 April 2007 to 30 April 2007 (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 April 2007 to 30 April 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
IO C 115, 25.5.2007, p. 3–9
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
25.5.2007 |
EN |
Official Journal of the European Union |
C 115/3 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 2007
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2007/C 115/03)
— 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 |
|||||
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20.4.2007 |
TOVIAZ |
fesoterodine |
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EU/1/07/386/001-010 |
Prolonged-release tablets |
G04B D11 |
24.4.2007 |
|||||
|
20.4.2007 |
Docetaxel Winthrop |
docetaxel |
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EU/1/07/384/001-002 |
Concentrate and solvent for solution for infusion |
L01CD02 |
24.4.2007 |
|||||
|
23.4.2007 |
Advagraf |
Tacrolimus |
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EU/1/07/387/001-008 |
Prolonged release hard capsules |
L04AA05 |
25.4.2007 |
|||||
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24.4.2007 |
Sebivo |
telbivudine |
|
EU/1/07/388/001 |
Film-coated tablet |
J05AF11 |
26.4.2007 |
— Modification 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 |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||||||
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2.4.2007 |
Dynepo |
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EU/1/02/211/001-005 EU/1/02/211/010-012 |
4.4.2007 |
||||||
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2.4.2007 |
Prevenar |
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EU/1/00/167/001-007 |
4.4.2007 |
||||||
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2.4.2007 |
Xigris |
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EU/1/02/225/001-002 |
4.4.2007 |
||||||
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2.4.2007 |
AZILECT |
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EU/1/04/304/001-007 |
4.4.2007 |
||||||
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2.4.2007 |
Enbrel |
|
EU/1/99/126/013-018 |
4.4.2007 |
||||||
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4.4.2007 |
Cerezyme |
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EU/1/97/053/001-005 |
11.4.2007 |
||||||
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11.4.2007 |
Panretin |
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EU/1/00/149/001 |
13.4.2007 |
||||||
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13.4.2007 |
|||||||||
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11.4.2007 |
TARGRETIN |
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EU/1/01/178/001 |
13.4.2007 |
||||||
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13.4.2007 |
|||||||||
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13.4.2007 |
Infanrix Penta |
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EU/1/00/153/001-010 |
17.4.2007 |
||||||
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13.4.2007 |
Infanrix Hexa |
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EU/1/00/152/001-018 |
17.4.2007 |
||||||
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13.4.2007 |
Foscan |
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EU/1/01/197/001-002 |
18.4.2007 |
||||||
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13.4.2007 |
Revatio |
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EU/1/05/318/001 |
17.4.2007 |
||||||
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13.4.2007 |
Glivec |
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EU/1/01/198/001-013 |
17.4.2007 |
||||||
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17.4.2007 |
Cystagon |
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EU/1/97/039/001-004 |
19.4.2007 |
||||||
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17.4.2007 |
Teslascan |
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EU/1/97/040/001-002 |
19.4.2007 |
||||||
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17.4.2007 |
Dynepo |
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EU/1/02/211/001-005 EU/1/02/211/010-012 |
19.4.2007 |
||||||
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20.4.2007 |
Quixidar |
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EU/1/02/207/001-020 |
24.4.2007 |
||||||
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20.4.2007 |
Arixtra |
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EU/1/02/206/001-020 |
24.4.2007 |
||||||
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20.4.2007 |
Omnitrope |
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EU/1/06/332/004-006 |
24.4.2007 |
||||||
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23.4.2007 |
Azomyr |
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EU/1/00/157/035-067 |
25.4.2007 |
||||||
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23.4.2007 |
Neoclarityn |
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EU/1/00/161/035-067 |
25.4.2007 |
||||||
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23.4.2007 |
Aerius |
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EU/1/00/160/037-069 |
25.4.2007 |
||||||
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23.4.2007 |
Temodal |
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EU/1/98/096/009-012 |
25.4.2007 |
||||||
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23.4.2007 |
Dynastat |
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EU/1/02/209/001-008 |
25.4.2007 |
||||||
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23.4.2007 |
M-M-RVAXPRO |
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EU/1/06/337/001-013 |
25.4.2007 |
||||||
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23.4.2007 |
Avastin |
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EU/1/04/300/001-002 |
25.4.2007 |
||||||
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23.4.2007 |
Kinzalkomb |
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EU/1/02/214/001-010 |
25.4.2007 |
||||||
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23.4.2007 |
MicardisPlus |
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EU/1/02/213/001-016 |
25.4.2007 |
||||||
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24.4.2007 |
Macugen |
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EU/1/05/325/001 |
26.4.2007 |
||||||
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24.4.2007 |
Kineret |
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EU/1/02/203/001-004 |
26.4.2007 |
||||||
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24.4.2007 |
Truvada |
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EU/1/04/305/001 |
26.4.2007 |
||||||
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24.4.2007 |
Herceptin |
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EU/1/00/145/001 |
26.4.2007 |
||||||
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24.4.2007 |
NovoMix |
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EU/1/00/142/004-005 EU/1/00/142/009-010 |
26.4.2007 |
||||||
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24.4.2007 |
Aldara |
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EU/1/98/080/001 |
26.4.2007 |
||||||
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24.4.2007 |
DaTSCAN |
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EU/1/00/135/001-002 |
26.4.2007 |
||||||
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25.4.2007 |
Bondenza |
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EU/1/03/266/001-006 |
30.4.2007 |
||||||
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25.4.2007 |
Bonviva |
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EU/1/03/265/001-006 |
30.4.2007 |
||||||
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25.4.2007 |
Xigris |
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EU/1/02/225/001-002 |
27.4.2007 |
||||||
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25.4.2007 |
Emtriva |
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EU/1/03/261/001-003 |
27.4.2007 |
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26.4.2007 |
Baraclude |
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EU/1/06/343/001-005 |
30.4.2007 |
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26.4.2007 |
Lysodren |
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EU/1/04/273/001 |
30.4.2007 |
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26.4.2007 |
Champix |
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EU/1/06/360/001-011 |
30.4.2007 |
||||||
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26.4.2007 |
REYATAZ |
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EU/1/03/267/001-007 |
30.4.2007 |
— 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 |
|||||
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13.4.2007 |
Slentrol |
Dirlotapide |
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EU/2/07/071/001-003 |
Oral solution |
QA08AB91 |
17.4.2007 |
— 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 |
||||
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20.4.2007 |
Metacam |
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EU/2/97/004/012-013 EU/2/97/004/026 |
24.4.2007 |
||||
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24.4.2007 |
Oxyglobin |
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EU/2/99/015/001 |
26.4.2007 |
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 |
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7, Westferry Circus |
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Canary Wharf |
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London E14 4HB |
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United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.