Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 30 June 2021

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2021/C 346/01)

— 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 11.1.2021 Pylobactell Torbet Laboratories Ireland Limited 20 Holles Street, Dublin 2, Ireland EU/1/98/064 30.4.2021 22.1.2021 Cholib Mylan IRE Healthcare Ltd Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/13/866 30.4.2021 11.2.2021 Flixabi Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/16/1106 30.3.2021 18.2.2021 Renvela Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/09/521 22.2.2021 9.3.2021 Diacomit Biocodex 7 avenue Gallieni, 94250 Gentilly, France EU/1/06/367 5.4.2021 9.3.2021 Stelara Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/08/494 10.3.2021 26.3.2021 Grasustek Juta Pharma GmbH Gutenbergstr. 13, 24941, Flensburg, Deutschland EU/1/19/1375 29.4.2021 26.3.2021 Memantine Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/13/827 30.4.2021 26.3.2021 Ranexa Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Luxembourg EU/1/08/462 13.4.2021 26.3.2021 Tepadina ADIENNE S.r.l.S.U. Via Galileo Galilei 19, 20867 Caponago (MB), Italia EU/1/10/622 13.4.2021 26.3.2021 Xenical CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24, 17489 Greifswald, Deutschland EU/1/98/071 14.4.2021 31.3.2021 Jinarc Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland EU/1/15/1000 14.4.2021 21.4.2021 Azomyr N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/00/157 26.4.2021 21.4.2021 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/02/205 17.5.2021 21.4.2021 Mepact Takeda France SAS 112 avenue Kléber, 75116 Paris, France EU/1/08/502 18.5.2021 21.4.2021 Repatha Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1016 23.4.2021 21.4.2021 Samsca Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland EU/1/09/539 12.5.2021 30.4.2021 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498 21.6.2021 19.5.2021 Clopidogrel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/540 21.5.2021 19.5.2021 Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1133 1.6.2021 19.5.2021 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535 20.5.2021 27.5.2021 Siklos Addmedica 37 rue de Caumartin, 75009 Paris, France EU/1/07/397 7.6.2021

— Withdrawal of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 26.3.2021 Crixivan Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/96/024 29.3.2021

— Issuing 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 INN (International Non-Proprietary Name) Holder of the marketing authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 20.4.2021 Daxocox Enflicoxib Ecuphar NV Legeweg 157-i, 8020 Oostkamp, België EU/2/21/270 Tablet QM01AH95 21.4.2021

— 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 26.4.2021 Palladia Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/100 12.7.2021 9.6.2021 Equisolon Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/14/161 29.7.2021 22.6.2021 GUMBOHATCH Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/19/245 28.6.2021

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.