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Document 52012XC0831(04)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
OJ C 264, 31.8.2012, p. 1–8
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
31.8.2012 |
EN |
Official Journal of the European Union |
C 264/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
2012/C 264/01
— Issuing of a marketing authorization (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 authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||
20.7.2012 |
Bretaris Genuair |
aclidinium bromide |
|
EU/1/12/781/001-003 |
Inhalation powder |
R03BB05 |
25.7.2012 |
||
20.7.2012 |
Eklira Genuair |
aclidinium bromide |
|
EU/1/12/778/001-003 |
Inhalation powder |
R03BB05 |
25.7.2012 |
||
20.7.2012 |
Jentadueto |
linagliptin/metformin hydrochloride |
|
EU/1/12/780/001-028 |
Film-coated tablet |
A10BD11 |
25.7.2012 |
||
23.7.2012 |
Fycompa |
Perampanel |
|
EU/1/12/776/001-016 |
Film-coated tablet |
N03AX22 |
25.7.2012 |
||
23.7.2012 |
Kalydeco |
ivacaftor |
|
EU/1/12/782/001-002 |
Film-coated tablet |
Pending |
25.7.2012 |
— Modification of a marketing authorization (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 authorization |
Number of the entry in the Community Register |
Date of notification |
||
3.7.2012 |
Insuman |
|
EU/1/97/030/028-201 |
5.7.2012 |
||
3.7.2012 |
Kinzalkomb |
|
EU/1/02/214/001-015 |
5.7.2012 |
||
3.7.2012 |
MicardisPlus |
|
EU/1/02/213/001-023 |
5.7.2012 |
||
3.7.2012 |
Prevenar 13 |
|
EU/1/09/590/001-006 |
5.7.2012 |
||
4.7.2012 |
Arixtra |
|
EU/1/02/206/001-035 |
6.7.2012 |
||
4.7.2012 |
Iasibon |
|
EU/1/10/659/001-010 |
6.7.2012 |
||
4.7.2012 |
Potactasol |
|
EU/1/10/660/001-002 |
6.7.2012 |
||
6.7.2012 |
Ganfort |
|
EU/1/06/340/001-002 |
10.7.2012 |
||
6.7.2012 |
Olazax |
|
EU/1/09/597/001-005 |
10.7.2012 |
||
6.7.2012 |
Simulect |
|
EU/1/98/084/001-002 |
10.7.2012 |
||
6.7.2012 |
Trizivir |
|
EU/1/00/156/002-004 |
10.7.2012 |
||
12.7.2012 |
Edarbi |
|
EU/1/11/734/001-018 |
17.7.2012 |
||
12.7.2012 |
Ipreziv |
|
EU/1/11/735/001-018 |
17.7.2012 |
||
16.7.2012 |
Olanzapine Glenmark |
|
EU/1/09/587/001-017 |
18.7.2012 |
||
20.7.2012 |
Arzerra |
|
EU/1/10/625/001 EU/1/10/625/003 |
24.7.2012 |
||
20.7.2012 |
Avamys |
|
EU/1/07/434/001-003 |
24.7.2012 |
||
20.7.2012 |
BeneFIX |
|
EU/1/97/047/004-007 |
25.7.2012 |
||
20.7.2012 |
Celsentri |
|
EU/1/07/418/001-010 |
25.7.2012 |
||
20.7.2012 |
Cyanokit |
|
EU/1/07/420/001-002 |
25.7.2012 |
||
20.7.2012 |
InductOs |
|
EU/1/02/226/001 |
25.7.2012 |
||
20.7.2012 |
Intelence |
|
EU/1/08/468/001-002 |
24.7.2012 |
||
23.7.2012 |
Afinitor |
|
EU/1/09/538/001-008 |
25.7.2012 |
||
23.7.2012 |
Alimta |
|
EU/1/04/290/001-002 |
27.7.2012 |
||
23.7.2012 |
Bridion |
|
EU/1/08/466/001-002 |
25.7.2012 |
||
23.7.2012 |
Cayston |
|
EU/1/09/543/001-002 |
25.7.2012 |
||
23.7.2012 |
Epivir |
|
EU/1/96/015/001-005 |
27.7.2012 |
||
23.7.2012 |
Eucreas |
|
EU/1/07/425/001-018 |
25.7.2012 |
||
23.7.2012 |
Galvus |
|
EU/1/07/414/001-010 EU/1/07/414/018 |
27.7.2012 |
||
23.7.2012 |
Humira |
|
EU/1/03/256/001-010 |
27.7.2012 |
||
23.7.2012 |
Ketek |
|
EU/1/01/191/001-005 |
25.7.2012 |
||
23.7.2012 |
Lumigan |
|
EU/1/02/205/001-004 |
25.7.2012 |
||
23.7.2012 |
Oslif Breezhaler |
|
EU/1/09/586/001-010 |
25.7.2012 |
||
26.7.2012 |
Celvapan |
|
EU/1/08/506/001 |
30.7.2012 |
||
26.7.2012 |
Esmya |
|
EU/1/12/750/001 |
30.7.2012 |
||
26.7.2012 |
Evicel |
|
EU/1/08/473/001-003 |
30.7.2012 |
||
26.7.2012 |
Grepid |
|
EU/1/09/535/001-016 |
30.7.2012 |
||
26.7.2012 |
Onbrez Breezhaler |
|
EU/1/09/593/001-010 |
30.7.2012 |
||
26.7.2012 |
Pradaxa |
|
EU/1/08/442/001-016 |
30.7.2012 |
||
26.7.2012 |
Silapo |
|
EU/1/07/432/001-022 |
30.7.2012 |
||
26.7.2012 |
Votubia |
|
EU/1/11/710/001-007 |
30.7.2012 |
||
26.7.2012 |
Zalasta |
|
EU/1/07/415/001-056 |
30.7.2012 |
||
31.7.2012 |
Enbrel |
|
EU/1/99/126/001-022 |
3.8.2012 |
||
31.7.2012 |
Isentress |
|
EU/1/07/436/001-002 |
3.8.2012 |
||
31.7.2012 |
NovoRapid |
|
EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-015 EU/1/99/119/017-023 |
3.8.2012 |
||
31.7.2012 |
Tyverb |
|
EU/1/07/440/001-007 |
2.8.2012 |
||
31.7.2012 |
Victrelis |
|
EU/1/11/704/001-002 |
3.8.2012 |
— Withdrawal of a marketing authorization (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 authorization |
Number of the entry in the Community Register |
Date of notification |
||
4.7.2012 |
Sprimeo |
|
EU/1/07/407/001-040 |
6.7.2012 |
||
6.7.2012 |
Sprimeo HCT |
|
EU/1/11/683/001-080 |
10.7.2012 |
||
16.7.2012 |
Regranex |
|
EU/1/99/101/001 |
18.7.2012 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2) ): Accepted
Date of the Décision |
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 |
||
16.7.2012 |
Nobivac L4 |
— |
|
EU/2/12/143/001-005 |
Suspension for injection |
QI07AB01 |
18.7.2012 |
||
23.7.2012 |
Cardalis |
Benazepril hydrochloride, Spironolactone |
|
EU/2/12/142/001-006 |
Tablet |
QC09BA07 |
25.7.2012 |
— Modification of a marketing authorization (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 authorization |
Number of the entry in the Community Register |
Date of notification |
||
4.7.2012 |
Proteq West Nile |
|
EU/2/11/129/001-004 |
6.7.2012 |
||
6.7.2012 |
Vaxxitek HVT+ IBD |
|
EU/2/02/032/001-002 |
10.7.2012 |
||
12.7.2012 |
Ingelvac CircoFLEX |
|
EU/2/07/079/001-008 |
17.7.2012 |
||
12.7.2012 |
Novem |
|
EU/2/04/042/001-014 |
17.7.2012 |
||
20.7.2012 |
ProMeris |
|
EU/2/06/064/001-004 |
25.7.2012 |
||
20.7.2012 |
ProMeris Duo |
|
EU/2/06/065/001-010 |
25.7.2012 |
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 |
UK-LONDON E14 4H |
(1) OJ L 136, 30.4.2004, p. 1.
(2) OJ L 136, 30.4.2004, p. 1.