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Document 52010XC0129(01)
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009 (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 authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009 (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 authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
SL C 22, 29.1.2010, p. 2–12
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
29.1.2010 |
EN |
Official Journal of the European Union |
C 22/2 |
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
2010/C 22/02
— Issuing of a marketing authorisation (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 authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||||||
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4.11.2009 |
Repaglinide Krka |
Repaglinide |
|
EU/1/09/579/001-018 |
Tablet |
A10B X02 |
6.11.2009 |
||||||
|
4.11.2009 |
Copalia HCT |
amlodipine besylate/valsartan/hydrochlorothiazide |
|
EU/1/09/575/001-060 |
Film-coated tablet |
C09DX01 |
6.11.2009 |
||||||
|
4.11.2009 |
Dafiro HCT |
amlodipine besylate/valsartan/hydrochlorothiazide |
|
EU/1/09/574/001-060 |
Film-coated tablet |
C09DX01 |
6.11.2009 |
||||||
|
26.11.2009 |
Multaq |
dronedarone |
|
EU/1/09/591/001-004 |
Film-coated tablet |
Not applicable |
1.12.2009 |
||||||
|
26.11.2009 |
Irbesartan/Hydrochlorothiazide Teva |
hydrochlorothiazide |
|
EU/1/09/583/001-072 |
Film-coated tablet |
C09D A04 |
1.12.2009 |
||||||
|
30.11.2009 |
Sildenafil Teva |
Sildenafil |
|
EU/1/09/584/001-018 |
Film-coated tablet |
G04BE03 |
2.12.2009 |
||||||
|
30.11.2009 |
Nevirapine Teva |
nevirapine |
|
EU/1/09/598/001-004 |
Tablet |
J05AG01 |
2.12.2009 |
||||||
|
30.11.2009 |
Hirobriz Breezhaler |
Indacaterol |
|
EU/1/09/594/001-010 |
Inhalation powder |
Not applicable |
2.12.2009 |
||||||
|
30.11.2009 |
Onbrez Breezhaler |
Indacaterol |
|
EU/1/09/593/001-010 |
Inhalation powder |
Not applicable |
2.12.2009 |
||||||
|
30.11.2009 |
Oslif Breezhaler |
Indacaterol |
|
EU/1/09/586/001-010 |
Inhalation powder |
Not applicable |
2.12.2009 |
||||||
|
30.11.2009 |
Zutectra |
Human Hepatitis B Immunoglobulin |
|
EU/1/09/600/001 |
Solution for injection |
J06BB04 |
2.12.2009 |
— Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||||||||
|
4.11.2009 |
Intelence |
|
EU/1/08/468/001 |
6.11.2009 |
||||||||
|
4.11.2009 |
Optisulin |
|
EU/1/00/133/001-032 |
6.11.2009 |
||||||||
|
4.11.2009 |
Lantus |
|
EU/1/00/134/001-037 |
6.11.2009 |
||||||||
|
4.11.2009 |
Ketek |
|
EU/1/01/191/001-005 |
6.11.2009 |
||||||||
|
4.11.2009 |
Osseor |
|
EU/1/04/287/001-006 |
6.11.2009 |
||||||||
|
4.11.2009 |
Protelos |
|
EU/1/04/288/001-006 |
6.11.2009 |
||||||||
|
5.11.2009 |
Abilify |
|
EU/1/04/276/001-020 EU/1/04/276/024-036 |
10.11.2009 |
||||||||
|
5.11.2009 |
Tyverb |
|
EU/1/07/440/001-002 |
9.11.2009 |
||||||||
|
5.11.2009 |
Pre-pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals |
|
EU/1/08/478/001 |
9.11.2009 |
||||||||
|
5.11.2009 |
Celsentri |
|
EU/1/07/418/001-010 |
9.11.2009 |
||||||||
|
5.11.2009 |
Invega |
|
EU/1/07/395/001-095 |
9.11.2009 |
||||||||
|
5.11.2009 |
Foscan |
|
EU/1/01/197/003-005 |
9.11.2009 |
||||||||
|
6.11.2009 |
Fosavance |
|
EU/1/05/310/001-009 |
10.11.2009 |
||||||||
|
9.11.2009 |
Januvia |
|
EU/1/07/383/001-018 |
11.11.2009 |
||||||||
|
11.11.2009 |
Celvapan |
|
EU/1/08/506/001 |
12.11.2009 |
||||||||
|
11.11.2009 |
Focetria |
|
EU/1/07/385/001-002 EU/1/07/385/004 |
12.11.2009 |
||||||||
|
11.11.2009 |
Pandemrix |
|
EU/1/08/452/001 |
12.11.2009 |
||||||||
|
11.11.2009 |
Insuman |
|
EU/1/97/030/028-195 |
13.11.2009 |
||||||||
|
11.11.2009 |
PegIntron |
Schering Plough Europe
|
EU/1/00/131/001-050 |
13.11.2009 |
||||||||
|
11.11.2009 |
Soliris |
|
EU/1/07/393/001 |
13.11.2009 |
||||||||
|
11.11.2009 |
Rebetol |
Schering Plough Europe
|
EU/1/99/107/001-005 |
13.11.2009 |
||||||||
|
12.11.2009 |
Intelence |
|
EU/1/08/468/001 |
17.11.2009 |
||||||||
|
12.11.2009 |
IntronA |
Schering Plough Europe
|
EU/1/99/127/001-044 |
17.11.2009 |
||||||||
|
12.11.2009 |
ViraferonPeg |
Schering Plough Europe
|
EU/1/00/132/001-050 |
17.11.2009 |
||||||||
|
19.11.2009 |
IntronA |
Schering Plough Europe
|
EU/1/99/127/031-039 |
23.11.2009 |
||||||||
|
19.11.2009 |
Clopidogrel Teva Pharma |
Teva Pharma B.V.
|
EU/1/09/561/001-009 |
23.11.2009 |
||||||||
|
20.11.2009 |
Circadin |
|
EU/1/07/392/001-002 |
18.12.2009 |
||||||||
|
20.11.2009 |
Bondronat |
|
EU/1/96/012/004 EU/1/96/012/009-013 |
24.11.2009 |
||||||||
|
20.11.2009 |
Ebixa |
|
EU/1/02/219/001-003 EU/1/02/219/005-049 |
24.11.2009 |
||||||||
|
20.11.2009 |
Mycamine |
|
EU/1/08/448/001-002 |
24.11.2009 |
||||||||
|
20.11.2009 |
NeoRecormon |
|
EU/1/97/031/019-046 |
24.11.2009 |
||||||||
|
20.11.2009 |
MabCampath |
|
EU/1/01/193/001-002 |
24.11.2009 |
||||||||
|
20.11.2009 |
Somavert |
|
EU/1/02/240/001-004 |
24.11.2009 |
||||||||
|
20.11.2009 |
Reyataz |
|
EU/1/03/267/001-010 |
24.11.2009 |
||||||||
|
20.11.2009 |
Xeristar |
|
EU/1/04/297/001-008 |
24.11.2009 |
||||||||
|
20.11.2009 |
Regranex |
|
EU/1/99/101/001 |
24.11.2009 |
||||||||
|
20.11.2009 |
Ziagen |
|
EU/1/99/112/001-002 |
24.11.2009 |
||||||||
|
20.11.2009 |
Cymbalta |
|
EU/1/04/296/001-009 |
24.11.2009 |
||||||||
|
20.11.2009 |
Angiox |
|
EU/1/04/289/001-002 |
24.11.2009 |
||||||||
|
20.11.2009 |
Agenerase |
|
EU/1/00/148/001-004 |
24.11.2009 |
||||||||
|
20.11.2009 |
RoActemra |
|
EU/1/08/492/001-006 |
24.11.2009 |
||||||||
|
23.11.2009 |
Nexavar |
|
EU/1/06/342/001 |
25.11.2009 |
||||||||
|
23.11.2009 |
Noxafil |
SP Europe
|
EU/1/05/320/001 |
25.11.2009 |
||||||||
|
23.11.2009 |
Pritor |
|
EU/1/98/089/001-022 |
25.11.2009 |
||||||||
|
23.11.2009 |
Aptivus |
|
EU/1/05/315/001-002 |
26.11.2009 |
||||||||
|
23.11.2009 |
Exjade |
|
EU/1/06/356/001-009 |
25.11.2009 |
||||||||
|
23.11.2009 |
Cervarix |
|
EU/1/07/419/001-012 |
25.11.2009 |
||||||||
|
23.11.2009 |
Trizivir |
|
EU/1/00/156/002-003 |
25.11.2009 |
||||||||
|
23.11.2009 |
Telzir |
|
EU/1/04/282/001-002 |
25.11.2009 |
||||||||
|
23.11.2009 |
Azilect |
|
EU/1/04/304/001-007 |
25.11.2009 |
||||||||
|
23.11.2009 |
Invega |
|
EU/1/07/395/001-095 |
25.11.2009 |
||||||||
|
23.11.2009 |
Puregon |
|
EU/1/96/008/001-041 |
25.11.2009 |
||||||||
|
23.11.2009 |
Kinzalmono |
|
EU/1/98/091/001-014 |
25.11.2009 |
||||||||
|
23.11.2009 |
Micardis |
|
EU/1/98/090/001-020 |
26.11.2009 |
||||||||
|
23.11.2009 |
Kaletra |
|
EU/1/01/172/001-007 |
25.11.2009 |
||||||||
|
24.11.2009 |
Synagis |
|
EU/1/99/117/001-002 |
26.11.2009 |
||||||||
|
24.11.2009 |
alli |
|
EU/1/07/401/007-010 |
26.11.2009 |
||||||||
|
25.11.2009 |
Kivexa |
|
EU/1/04/298/001-003 |
27.11.2009 |
||||||||
|
26.11.2009 |
Enbrel |
|
EU/1/99/126/001-021 |
1.12.2009 |
||||||||
|
26.11.2009 |
Enbrel |
|
EU/1/99/126/001-021 |
1.12.2009 |
||||||||
|
26.11.2009 |
Diacomit |
|
EU/1/06/367/001-012 |
1.12.2009 |
||||||||
|
26.11.2009 |
Intelence |
|
EU/1/08/468/001 |
1.12.2009 |
||||||||
|
26.11.2009 |
Abseamed |
|
EU/1/07/412/021-026 |
1.12.2009 |
||||||||
|
27.11.2009 |
Pandemrix |
|
EU/1/08/452/001 |
30.11.2009 |
||||||||
|
27.11.2009 |
Focetria |
|
EU/1/07/385/001-002 EU/1/07/385/004 |
30.11.2009 |
||||||||
|
30.11.2009 |
Velcade |
|
EU/1/04/274/001-002 |
2.12.2009 |
||||||||
|
30.11.2009 |
Champix |
|
EU/1/06/360/001-013 |
2.12.2009 |
||||||||
|
30.11.2009 |
Adcirca |
|
EU/1/08/476/001-006 |
2.12.2009 |
||||||||
|
30.11.2009 |
Docetaxel Winthrop |
|
EU/1/07/384/003-004 |
2.12.2009 |
||||||||
|
30.11.2009 |
Taxotere |
|
EU/1/95/002/003-004 |
2.12.2009 |
— Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004)
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||||||
|
11.11.2009 |
Irbesartan BMS |
|
EU/1/06/375/001-033 |
13.11.2009 |
||||||
|
11.11.2009 |
Irbesartan HCT BMS |
|
EU/1/06/369/001-028 |
13.11.2009 |
||||||
|
12.11.2009 |
Clopidogrel BMS |
|
EU/1/08/464/001-019 |
17.11.2009 |
||||||
|
26.11.2009 |
Paxene |
|
EU/1/99/113/001-004 |
10.12.2009 |
— Issuing of a marketing authorisation (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 authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||||
|
4.11.2009 |
Zolvix |
Monepantel |
|
EU/2/09/101/001-010 |
Oral solution |
QP52AX09 |
6.11.2009 |
— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||||||
|
18.11.2009 |
Dexdomitor |
|
EU/2/02/033/001-002 |
20.11.2009 |
||||||
|
19.11.2009 |
Improvac |
|
EU/2/09/095/001-003 |
23.11.2009 |
||||||
|
20.11.2009 |
Metacam |
|
EU/2/97/004/026 EU/2/97/004/033-034 |
24.11.2009 |
||||||
|
23.11.2009 |
Halocur |
|
EU/2/99/013/001-002 |
25.11.2009 |
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.