Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2020 to 31 August 2020

(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 367/01)

— 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 20.5.2020 Zeposia ozanimod Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/20/1442 Capsule, hard L04AA38 25.5.2020

— 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 17.4.2020 Natpar Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/15/1078 20.5.2020 23.4.2020 Cyanokit SERB S.A. Avenue Louise 480, 1050 Bruxelles, Belgique/Louizalaan 480, 1050 Brussel, België EU/1/07/420 12.5.2020 23.4.2020 Oncaspar Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/15/1070 13.5.2020 28.4.2020 Miglustat Gen.Orph Gen.Orph 185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France EU/1/17/1232 4.6.2002 28.4.2020 NeuroBloc Sloan Pharma S.a.r.l. 33 Rue de Puits Romain, 8070 Bertrange, Luxembourg EU/1/00/166 19.5.2020 28.4.2020 Privigen CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/08/446 20.5.2020 22.6.2020 Avonex Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/97/033 17.7.2020 25.6.2020 Emtricitabine/Tenofovir disoproxil Krka d.d. KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1182 20.7.2020 17.7.2020 Jentadueto Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/12/780 27.7.2020 17.7.2020 Zarzio Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/08/495 17.8.2020 27.7.2020 TOBI Podhaler Mylan IRE Healthcare Ltd Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/10/652 29.7.2020 31.7.2020 CABOMETYX Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/16/1136 6.8.2020 31.7.2020 Oprymea KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/469 13.8.2020 28.8.2020 Effentora Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/441 7.9.2020 28.8.2020 Olanzapine Glenmark Glenmark Arzneimittel GmbH Industriestr. 31, D — 82194 Gröbenzell, Deutschland EU/1/09/587 9.9.2020 28.8.2020 Olanzapine Glenmark Europe Glenmark Arzneimittel GmbH Industriestr. 31, D — 82194 Gröbenzell, Deutschland EU/1/09/588 9.9.2020

— Suspension of a marketing authorization (Article 20 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 25.3.2020 Ulipristal Acetate Gedeon Richter Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/18/1309 27.3.2020

— 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 24.4.2020 Suprelorin VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France EU/2/07/072 20.5.2020 24.6.2020 Novaquin Le Vet Beheer B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/15/186 20.7.2020 28.8.2020 Syvazul BTV LABORATORIOS SYVA, S.A.U. Av. Párroco Pablo Diez 49-57, 24010 León, España EU/2/18/231 7.9.2020

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.