Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2018 to 31 December 2019 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-06-26
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2020213EN.01000101.xml










26.6.2020   


EN


Official Journal of the European Union


C 213/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2018 to 31 December 2019
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2020/C 213/01)
—   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




29.10.2018


Eporatio


ratiopharm GmbH
Graf-Arco-Straße 3, 89079 Ulm, Deutschland


EU/1/09/573


31.10.2018




29.10.2018


Viramune


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/97/055


31.10.2018




28.11.2018


Keppra


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/00/146


30.11.2018




28.11.2018


Pioglitazone Teva


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/12/757


30.11.2018




28.11.2018


Pioglitazone Teva Pharma


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/12/758


30.11.2018




28.11.2018


Spinraza


Biogen Netherlands B.V.
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland


EU/1/17/1188


30.11.2018




20.12.2018


Vimizim


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland


EU/1/14/914


24.1.2019




11.4.2019


Apidra


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/04/285


16.4.2019




15.4.2019


Orencia


Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland


EU/1/07/389


17.4.2019




6.6.2019


Glustin


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/00/151


11.6.2019




27.6.2019


Xeljanz


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/17/1178


1.7.2019




23.8.2019


NutropinAq


Ipsen Pharma
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France


EU/1/00/164


27.8.2019




23.9.2019


Zebinix


Bial — Portela & Ca, SA
À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal


EU/1/09/514


25.9.2019




29.10.2019


Inhixa


Techdow Pharma Netherlands B.V.
Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland


EU/1/16/1132


15.11.2019




22.11.2019


Flixabi


Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft, Nederland


EU/1/16/1106


26.11.2019




—   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




26.4.2019


ERYSENG


Laboratorios Hipra, S.A.
Avda. La Selva, 135, 17170 Amer (Girona), España


EU/2/14/166


30.4.2019




29.8.2019


BROADLINE


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/13/157


2.9.2019




29.8.2019


VarroMed


BeeVital GmbH
Wiesenbergstrasse 19,A- 5164, Seeham, Österreich


EU/2/16/203


2.9.2019




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




Domenico Scarlattilaan 6




1083 HS Amsterdam




NETHERLANDS






(1)  OJ L 136, 30.4.2004, p. 1.