EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 52009XC0731(08)
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 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 June 2009 to 30 June 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 June 2009 to 30 June 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
OJ C 178, 31.7.2009, p. 15–23
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
31.7.2009 |
EN |
Official Journal of the European Union |
C 178/15 |
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009
(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 178/12
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
||||
10.6.2009 |
Renvela |
Sevelamer (carbonate) |
|
EU/1/09/521/001-003 EU/1/09/521/004-007 |
Film-coated tablet Powder for oral suspension |
V03AE02 |
12.6.2009 |
||||
12.6.2009 |
PANTOLOC Control |
Pantoprazole |
|
EU/1/09/519/001-004 |
Gastro-resistant tablet |
A02BC02 |
16.6.2009 |
||||
12.6.2009 |
PANTOZOL Control |
Pantoprazole |
|
EU/1/09/517/001-004 |
Gastro-resistant tablet |
A02BC02 |
16.6.2009 |
||||
12.6.2009 |
PANTECTA Control |
Pantoprazole |
|
EU/1/09/518/001-004 |
Gastro-resistant tablet |
A02BC02 |
16.6.2009 |
||||
12.6.2009 |
CONTROLOC Control |
Pantoprazole |
|
EU/1/09/515/001-004 |
Gastro-resistant tablet |
A02BC02 |
16.6.2009 |
||||
12.6.2009 |
SOMAC Control |
Pantoprazole |
|
EU/1/09/516/001-004 |
Gastro-resistant tablet |
A02BC02 |
16.6.2009 |
||||
24.6.2009 |
IRESSA |
Gefitinib |
|
EU/1/09/526/001 |
Film-coated tablet |
L01XE02 |
26.6.2009 |
||||
29.6.2009 |
Repaglinide Teva |
Repaglinide |
|
EU/1/09/530/001-015 |
Tablet |
A10BX02 |
1.7.2009 |
||||
30.6.2009 |
Victoza |
Liraglutide |
|
EU/1/09/529/001-005 |
Solution for injection in pre-filled pen |
A10BX07 |
2.7.2009 |
— Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
||||||||
2.6.2009 |
Avamys |
|
EU/1/07/434/001-003 |
5.6.2009 |
||||||||
2.6.2009 |
Alisade |
|
EU/1/08/474/001-003 |
5.6.2009 |
||||||||
2.6.2009 |
Ketek |
|
EU/1/01/191/001-005 |
5.6.2009 |
||||||||
2.6.2009 |
Stocrin |
|
EU/1/99/111/001-005 EU/1/99/111/008-011 |
5.6.2009 |
||||||||
2.6.2009 |
Velmetia |
|
EU/1/08/456/001-016 |
5.6.2009 |
||||||||
2.6.2009 |
Ferriprox |
|
EU/1/99/108/001-003 |
4.6.2009 |
||||||||
2.6.2009 |
Januvia |
|
EU/1/07/383/001-018 |
5.6.2009 |
||||||||
2.6.2009 |
Janumet |
|
EU/1/08/455/001-016 |
5.6.2009 |
||||||||
2.6.2009 |
Silgard |
|
EU/1/06/358/001-021 |
4.6.2009 |
||||||||
2.6.2009 |
Sustiva |
|
EU/1/99/110/001-005 EU/1/99/110/008-010 |
5.6.2009 |
||||||||
2.6.2009 |
Efficib |
|
EU/1/08/457/001-016 |
5.6.2009 |
||||||||
4.6.2009 |
Avandamet |
|
EU/1/03/258/001-022 |
8.6.2009 |
||||||||
4.6.2009 |
Ovitrelle |
|
EU/1/00/165/001-007 |
8.6.2009 |
||||||||
8.6.2009 |
Tasigna |
|
EU/1/07/422/001-004 |
10.6.2009 |
||||||||
8.6.2009 |
Ziagen |
|
EU/1/99/112/001-002 |
10.6.2009 |
||||||||
8.6.2009 |
Pergoveris |
|
EU/1/07/396/001-003 |
10.6.2009 |
||||||||
8.6.2009 |
Baraclude |
|
EU/1/06/343/001-007 |
10.6.2009 |
||||||||
8.6.2009 |
REYATAZ |
|
EU/1/03/267/001-010 |
10.6.2009 |
||||||||
8.6.2009 |
Abilify |
|
EU/1/04/276/001-020 EU/1/04/276/024-036 |
10.6.2009 |
||||||||
8.6.2009 |
Kivexa |
|
EU/1/04/298/001-003 |
10.6.2009 |
||||||||
9.6.2009 |
GONAL-f |
|
EU/1/95/001/001 EU/1/95/001/003-005 EU/1/95/001/009 EU/1/95/001/012 EU/1/95/001/021-022 EU/1/95/001/025-028 EU/1/95/001/031-035 |
11.6.2009 |
||||||||
17.6.2009 |
Erbitux |
|
EU/1/04/281/001-005 |
19.6.2009 |
||||||||
17.6.2009 |
Lucentis |
|
EU/1/06/374/001 |
19.6.2009 |
||||||||
18.6.2009 |
Vivanza |
|
EU/1/03/249/001-012 |
22.6.2009 |
||||||||
18.6.2009 |
Vasovist |
|
EU/1/05/313/001-009 |
22.6.2009 |
||||||||
18.6.2009 |
Angiox |
|
EU/1/04/289/001-002 |
22.6.2009 |
||||||||
18.6.2009 |
Emtriva |
|
EU/1/03/261/001-002 |
22.6.2009 |
||||||||
22.6.2009 |
Aclasta |
|
EU/1/05/308/001-002 |
24.6.2009 |
||||||||
22.6.2009 |
Yondelis |
|
EU/1/07/417/001-002 |
24.6.2009 |
||||||||
22.6.2009 |
Levitra |
|
EU/1/03/248/001-012 |
25.6.2009 |
||||||||
23.6.2009 |
Ebixa |
|
EU/1/02/219/001-049 |
25.6.2009 |
||||||||
23.6.2009 |
Prezista |
|
EU/1/06/380/004-005 |
25.6.2009 |
||||||||
23.6.2009 |
Prezista |
|
EU/1/06/380/001-002 |
25.6.2009 |
||||||||
23.6.2009 |
Yondelis |
|
EU/1/07/417/001-002 |
25.6.2009 |
||||||||
23.6.2009 |
Aptivus |
|
EU/1/05/315/002 |
25.6.2009 |
||||||||
23.6.2009 |
Aptivus |
|
EU/1/05/315/001 |
25.6.2009 |
||||||||
24.6.2009 |
Ariclaim |
|
EU/1/04/283/008-012 |
26.6.2009 |
||||||||
24.6.2009 |
YENTREVE |
|
EU/1/04/280/001-008 |
26.6.2009 |
||||||||
24.6.2009 |
Xeristar |
|
EU/1/04/297/001-008 |
29.6.2009 |
||||||||
24.6.2009 |
Neupro |
|
EU/1/05/331/001-055 |
26.6.2009 |
||||||||
24.6.2009 |
Cymbalta |
|
EU/1/04/296/001-009 |
26.6.2009 |
||||||||
24.6.2009 |
Axura |
|
EU/1/02/218/001-029 |
26.6.2009 |
||||||||
29.6.2009 |
RotaTeq |
|
EU/1/06/348/001-002 |
2.7.2009 |
||||||||
29.6.2009 |
Yttriga |
|
EU/1/05/322/001 |
1.7.2009 |
||||||||
29.6.2009 |
Kepivance |
|
EU/1/05/314/001 |
2.7.2009 |
||||||||
29.6.2009 |
Effentora |
|
EU/1/08/441/001-010 |
1.7.2009 |
||||||||
30.6.2009 |
Cerezyme |
|
EU/1/97/053/001-005 |
2.7.2009 |
||||||||
30.6.2009 |
Hepsera |
|
EU/1/03/251/001-002 |
2.7.2009 |
||||||||
30.6.2009 |
Kineret |
|
EU/1/02/203/001-004 |
2.7.2009 |
||||||||
30.6.2009 |
Ariclaim |
|
EU/1/04/283/008-012 |
2.7.2009 |
||||||||
30.6.2009 |
BeneFIX |
|
EU/1/97/047/001-007 |
2.7.2009 |
— Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
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 |
|||||
9.6.2009 |
Raptiva |
|
EU/1/04/291/001-003 |
11.6.2009 |
— Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2) ): 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 |
|||||
17.6.2009 |
Leucogen |
|
|
EU/2/09/096/001-002 |
Suspension for injection |
QI06AA01 |
19.6.2009 |
|||||
25.6.2009 |
Leucofeligen FeLV/RCP |
|
|
EU/2/09/097/001-002 |
Lyophilisate and solvent for suspension for injection |
QI06AH07 |
29.6.2009 |
— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
||||||||||
4.6.2009 |
Rheumocam |
|
EU/2/07/078/001-004 |
8.6.2009 |
||||||||||
8.6.2009 |
Circovac |
|
EU/2/07/075/001-004 |
10.6.2009 |
||||||||||
22.6.2009 |
ProMeris |
|
EU/2/06/064/001-004 |
25.6.2009 |
||||||||||
30.6.2009 |
Posatex |
|
EU/2/08/081/001-003 |
2.7.2009 |
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 |
London |
E14 4HB |
UNITED KINGDOM |
(1) OJ L 136, 30.4.2004, p. 1.
(2) OJ L 136, 30.4.2004, p. 1.