ISSN 1977-091X |
||
Official Journal of the European Union |
C 199 |
|
English edition |
Information and Notices |
Volume 57 |
Notice No |
Contents |
page |
|
IV Notices |
|
|
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
|
|
European Commission |
|
2014/C 199/01 |
||
EN |
|
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
27.6.2014 |
EN |
Official Journal of the European Union |
C 199/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2014 to 31 May 2014
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
2014/C 199/01
— 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 |
||
2.5.2014 |
Revinty Ellipta |
fluticasone furoate/vilanterol trifenatate |
|
EU/1/14/929 |
Inhalation powder, pre-dispensed |
R03AK10 |
6.5.2014 |
||
8.5.2014 |
Anoro |
umeclidinium bromide/vilanterol trifenatate |
|
EU/1/14/898 |
Inhalation powder, pre-dispensed |
R03AL03 |
13.5.2014 |
||
8.5.2014 |
Laventair |
umeclidinium bromide/vilanterol trifenatate |
|
EU/1/14/899 |
Inhalation powder, pre-dispensed |
R03AL03 |
13.5.2014 |
||
14.5.2014 |
OLYSIO |
simeprevir |
|
EU/1/14/924 |
Capsule, hard |
J05AE14 |
16.5.2014 |
||
22.5.2014 |
Ebilfumin |
oseltamivir |
|
EU/1/14/915 |
Capsule, hard |
J05AH02 |
27.5.2014 |
||
22.5.2014 |
Entyvio |
vedolizumab |
|
EU/1/14/923 |
Powder for concentrate for solution for infusion |
L04AA33 |
27.5.2014 |
||
22.5.2014 |
Jardiance |
Empagliflozin |
|
EU/1/14/930 |
Film-coated tablet |
A10BX12 |
27.5.2014 |
||
22.5.2014 |
Sylvant |
siltuximab |
|
EU/1/14/928 |
Powder for concentrate for solution for infusion |
Pending |
27.5.2014 |
— 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 |
||
2.5.2014 |
Invirase |
|
EU/1/96/026 |
6.5.2014 |
||
6.5.2014 |
NutropinAq |
|
EU/1/00/164 |
9.5.2014 |
||
6.5.2014 |
Rivastigmine 1 A Pharma |
|
EU/1/09/585 |
8.5.2014 |
||
6.5.2014 |
Vyndaqel |
|
EU/1/11/717 |
8.5.2014 |
||
7.5.2014 |
Tresiba |
|
EU/1/12/807 |
9.5.2014 |
||
7.5.2014 |
Trobalt |
|
EU/1/11/681 |
9.5.2014 |
||
8.5.2014 |
Clopidogrel Teva Pharma |
|
EU/1/09/561 |
14.5.2014 |
||
8.5.2014 |
Zylagren |
|
EU/1/09/558 |
13.5.2014 |
||
14.5.2014 |
Clopidogrel Krka |
|
EU/1/09/556 |
16.5.2014 |
||
14.5.2014 |
InductOs |
|
EU/1/02/226 |
16.5.2014 |
||
14.5.2014 |
Isentress |
|
EU/1/07/436 |
16.5.2014 |
||
14.5.2014 |
Pandemic influenza vaccine H5N1 BAXTER |
|
EU/1/09/571 |
16.5.2014 |
||
14.5.2014 |
XALKORI |
|
EU/1/12/793 |
16.5.2014 |
||
14.5.2014 |
Zyllt |
|
EU/1/09/553 |
16.5.2014 |
||
16.5.2014 |
Afinitor |
|
EU/1/09/538 |
20.5.2014 |
||
16.5.2014 |
Cimzia |
|
EU/1/09/544 |
20.5.2014 |
||
16.5.2014 |
Clopidogrel Teva |
|
EU/1/09/540 |
20.5.2014 |
||
16.5.2014 |
Clopidogrel Teva Pharma B.V. |
|
EU/1/10/649 |
20.5.2014 |
||
16.5.2014 |
Docetaxel Accord |
|
EU/1/12/769 |
20.5.2014 |
||
16.5.2014 |
Javlor |
|
EU/1/09/550 |
20.5.2014 |
||
16.5.2014 |
Vizarsin |
|
EU/1/09/551 |
20.5.2014 |
||
22.5.2014 |
Adjupanrix |
|
EU/1/09/578 |
27.5.2014 |
||
22.5.2014 |
Busilvex |
|
EU/1/03/254 |
27.5.2014 |
||
22.5.2014 |
Clopidogrel DURA |
|
EU/1/09/560 |
27.5.2014 |
||
22.5.2014 |
Clopidogrel Mylan |
|
EU/1/09/559 |
27.5.2014 |
||
22.5.2014 |
Clopidogrel ratiopharm GmbH |
|
EU/1/09/541 |
27.5.2014 |
||
22.5.2014 |
Clopidogrel TAD |
|
EU/1/09/555 |
27.5.2014 |
||
22.5.2014 |
Docetaxel Kabi |
|
EU/1/12/770 |
27.5.2014 |
||
22.5.2014 |
Fampyra |
|
EU/1/11/699 |
27.5.2014 |
||
22.5.2014 |
Grastofil |
|
EU/1/13/877 |
27.5.2014 |
||
22.5.2014 |
Iasibon |
|
EU/1/10/659 |
27.5.2014 |
||
22.5.2014 |
Ipreziv |
|
EU/1/11/735 |
27.5.2014 |
||
22.5.2014 |
Osseor |
|
EU/1/04/287 |
27.5.2014 |
||
22.5.2014 |
PegIntron |
|
EU/1/00/131 |
27.5.2014 |
||
22.5.2014 |
Prepandrix |
|
EU/1/08/453 |
27.5.2014 |
||
22.5.2014 |
Protelos |
|
EU/1/04/288 |
27.5.2014 |
||
22.5.2014 |
Selincro |
|
EU/1/12/815 |
27.5.2014 |
||
22.5.2014 |
Vaniqa |
|
EU/1/01/173 |
27.5.2014 |
||
22.5.2014 |
ViraferonPeg |
|
EU/1/00/132 |
27.5.2014 |
||
23.5.2014 |
Clopidogrel Acino |
|
EU/1/09/532 |
27.5.2014 |
||
23.5.2014 |
GILENYA |
|
EU/1/11/677 |
27.5.2014 |
||
23.5.2014 |
Invega |
|
EU/1/07/395 |
27.5.2014 |
||
23.5.2014 |
Mabthera |
|
EU/1/98/067 |
27.5.2014 |
||
23.5.2014 |
Nexavar |
|
EU/1/06/342 |
27.5.2014 |
||
23.5.2014 |
Suboxone |
|
EU/1/06/359 |
27.5.2014 |
— 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 |
||
16.5.2014 |
Preotact |
|
EU/1/06/339 |
20.5.2014 |
— 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 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 |
||
7.5.2014 |
Versican Plus DHPPi/L4 |
Versican Plus DHPPi/L4 |
|
EU/2/14/164 |
Lyophilisate and solvent for suspension for injection |
QI07AI02 |
9.5.2014 |
||
7.5.2014 |
Versican Plus DHPPi/L4R |
Versican Plus DHPPi/L4R |
|
EU/2/14/163 |
Lyophilisate and solvent for suspension for injection |
QI07AJ06 |
9.5.2014 |
— 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 |
||
7.5.2014 |
Recocam |
|
EU/2/11/133 |
8.5.2014 |
||
16.5.2014 |
Circovac |
|
EU/2/07/075 |
20.5.2014 |
— Withdrawal of a marketing authorization (Article 38 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 |
||
6.5.2014 |
Flexicam |
|
EU/2/06/058 |
8.5.2014 |
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.