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Document 52016XC1230(03)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2016 to 29 February 2016 (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 February 2016 to 29 February 2016 (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 February 2016 to 29 February 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
OJ C 490, 30.12.2016, p. 13–13
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
30.12.2016 |
EN |
Official Journal of the European Union |
C 490/13 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2016 to 29 February 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 490/03)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
|
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 |
|
11.2.2016 |
Solumarv |
Marvel Lifesciences Limited Congress House Lyon Road HA1 2EN Harrow United Kingdom |
— |
15.2.2016 |
— 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 |
|
11.2.2016 |
Tybost |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/872 |
7.3.2016 |
|
26.2.2016 |
Clopidogrel Zentiva |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/08/465 |
1.3.2016 |
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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European Medicines Agency |
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30 Churchill Place |
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Canary Wharf |
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London E14 5EU |
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United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.