Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2020 to 31 March 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 135/01)

— Issuing 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 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 2.3.2020 Givlaari givosiran Alnylam Netherlands B.V. Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland EU/1/20/1428 Solution for injection Pending 4.3.2020 24.3.2020 Azacitidine Betapharm Azacitidine betapharm Arzneimittel GmbH Kobelweg 95, 86156 Augsburg, Deutschland EU/1/19/1416 Powder for suspension for injection L01BC07 25.3.2020 24.3.2020 Liumjev Insulin lispro Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/20/1422 Solution for injection A10AB04 26.3.2020 27.3.2020 Azacitidine Mylan Azacitidine Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1426 Powder for suspension for injection L01BC07 30.3.2020 27.3.2020 NUBEQA darolutamide Bayer AG D-51368 Leverkusen, Deutschland EU/1/20/1432 Film-coated tablet L02BB06 30.3.2020 27.3.2020 Nustendi bempedoic acid/ezetimibe FGK Representative Service GmbH Heimeranstraße 35, 80339 München, Deutschland EU/1/20/1424 Film-coated tablet Pending 31.3.2020 27.3.2020 Staquis crisaborole Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/19/1421 Ointment D11AH06 1.4.2020

— 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 3.3.2020 Mabthera Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/98/067 5.3.2020 3.3.2020 Maviret AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/17/1213 5.3.2020 9.3.2020 Alkindi Diurnal Europe B.V. Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland EU/1/17/1260 11.3.2020 9.3.2020 Ameluz Biofrontera Bioscience GmbH Hemmelrather Weg 201, 51377 Leverkusen, Deutschland EU/1/11/740 11.3.2020 9.3.2020 BiResp Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/921 11.3.2020 9.3.2020 Cervarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/07/419 11.3.2020 9.3.2020 Duloxetine Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1028 11.3.2020 9.3.2020 DuoResp Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/920 11.3.2020 9.3.2020 Fortacin Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/13/881 11.3.2020 9.3.2020 IKERVIS Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi EU/1/15/990 11.3.2020 9.3.2020 Imvanex Bavarian Nordic A/S Hejreskovvej 10a, 3490 Kvistgaard, Danmark EU/1/13/855 11.3.2020 9.3.2020 Integrilin GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/99/109 11.3.2020 9.3.2020 Iressa AstraZeneca AB 151 85 Södertälje, Sverige EU/1/09/526 11.3.2020 9.3.2020 Kineret Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/02/203 11.3.2020 9.3.2020 Lojuxta Amryt Pharmaceuticals DAC 90 Harcourt Street, Dublin 2, Ireland EU/1/13/851 11.3.2020 9.3.2020 Luxturna Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1331 11.3.2020 9.3.2020 Nyxoid Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland EU/1/17/1238 11.3.2020 9.3.2020 Oncaspar Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/15/1070 11.3.2020 9.3.2020 Onpattro Alnylam Netherlands B.V. Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland EU/1/18/1320 11.3.2020 9.3.2020 Ozurdex Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/10/638 11.3.2020 9.3.2020 Pelmeg Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland EU/1/18/1328 11.3.2020 9.3.2020 Pregabalin Pfizer Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/14/916 11.3.2020 9.3.2020 Qtern AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1108 11.3.2020 9.3.2020 Rezolsta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/967 11.3.2020 9.3.2020 Ristaben Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/10/621 18.3.2020 9.3.2020 Selincro H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/12/815 11.3.2020 9.3.2020 Suliqua Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/16/1157 11.3.2020 9.3.2020 TAKHZYRO Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/18/1340 11.3.2020 9.3.2020 Terrosa Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/16/1159 11.3.2020 9.3.2020 Tesavel Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/435 11.3.2020 9.3.2020 Trajenta Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/11/707 11.3.2020 9.3.2020 Tybost Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/872 11.3.2020 9.3.2020 Ulunar Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/917 11.3.2020 9.3.2020 Venclyxto AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/16/1138 11.3.2020 9.3.2020 XALKORI Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/12/793 11.3.2020 9.3.2020 Xelevia Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/382 11.3.2020 9.3.2020 Xoterna Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/863 11.3.2020 10.3.2020 Epivir ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/96/015 12.3.2020 10.3.2020 Ixiaro Valneva Austria GmbH Campus Vienna Biocenter 3, 1030 Wien, Österreich EU/1/08/501 12.3.2020 10.3.2020 Pemetrexed Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1037 12.3.2020 10.3.2020 Ranexa Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Luxembourg EU/1/08/462 12.3.2020 16.3.2020 Akynzeo Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland EU/1/15/1001 18.3.2020 16.3.2020 Olazax Disperzi Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b, 14078 Praha 4, Česká republika EU/1/09/592 18.3.2020 16.3.2020 Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1089 18.3.2020 16.3.2020 Waylivra Akcea Therapeutics Ireland Limited Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland EU/1/19/1360 18.3.2020 24.3.2020 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/12/792 25.3.2020 24.3.2020 Epclusa Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1116 25.3.2020 24.3.2020 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 30.3.2020 24.3.2020 Rapiscan GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge EU/1/10/643 26.3.2020 24.3.2020 Shingrix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/18/1272 25.3.2020 24.3.2020 Voriconazole Hikma Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal EU/1/15/1004 26.3.2020 27.3.2020 Alofisel Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/17/1261 6.4.2020 27.3.2020 EVOTAZ Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1025 6.4.2020 27.3.2020 Halimatoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1288 5.4.2020 27.3.2020 Hefiya Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1287 6.4.2020 27.3.2020 Hyrimoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1286 5.4.2020 27.3.2020 Lenalidomide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/18/1316 31.3.2020 27.3.2020 Ozempic Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/17/1251 31.3.2020 27.3.2020 SomaKit TOC Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France EU/1/16/1141 6.4.2020 27.3.2020 Vaborem Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Luxembourg EU/1/18/1334 30.3.2020

— Suspension of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 25.3.2020 Esmya Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/12/750 27.3.2020

— 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 4.3.2020 Rabitec IDT Biologika GmbH Am Pharmapark, 06861 Dessau-Rosslau, Deutschland EU/2/17/219 6.3.2020 4.3.2020 Respiporc Flu3 Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/09/103 6.3.2020 9.3.2020 Activyl Tick Plus Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/11/137 11.3.2020 9.3.2020 Clomicalm Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/98/007 11.3.2020 9.3.2020 ECOPORC SHIGA Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/13/149 11.3.2020 24.3.2020 Activyl Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/10/118 25.3.2020 27.3.2020 CLYNAV Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/16/197 31.3.2020 27.3.2020 MS-H vaccine Pharmsure Veterinary Products Europe Ltd 4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland EU/2/11/126 31.3.2020

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.