Official Journal of the European Union

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.