Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2020 to 31 October 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 409/01)

— 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 27.10.2020 ARIKAYCE liposomal amikacin Insmed Netherlands B.V. Stadsplateau 7, 3521 AZ Utrecht, Nederland EU/1/20/1469 Nebuliser dispersion J01GB06 28.10.2020 28.10.2020 Adakveo crizanlizumab Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1476 Concentrate for solution for infusion B06AX01 29.10.2020

— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

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 28.10.2020 Turalio Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland — 29.10.2020

— 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 9.10.2020 Briviact UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/15/1073 12.10.2020 9.10.2020 Celsentri ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/07/418 14.10.2020 9.10.2020 Cuprior Orphalan 226 Boulevard Voltaire, 75011 Paris, France EU/1/17/1199 12.10.2020 9.10.2020 Doptelet Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/19/1373 16.10.2020 9.10.2020 Elonva Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/09/609 12.10.2020 9.10.2020 Laventair Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/899 14.10.2020 9.10.2020 Moventig Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/14/962 14.10.2020 9.10.2020 Nexavar Bayer AG D-51368 Leverkusen, Deutschland EU/1/06/342 12.10.2020 9.10.2020 Pemetrexed Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/15/1071 13.10.2020 9.10.2020 Ritemvia Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1207 12.10.2020 9.10.2020 Rixathon Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1185 12.10.2020 9.10.2020 Riximyo Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1184 13.10.2020 9.10.2020 Sialanar Proveca Pharma Limited Marine House, Clanwilliam Place, Dublin 2, Ireland EU/1/16/1135 15.10.2020 9.10.2020 Skilarence Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/17/1201 13.10.2020 9.10.2020 Spherox CO.DON AG Warthestraße 21, 14513 Teltow, Deutschland EU/1/17/1181 14.10.2020 9.10.2020 Viekirax AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/982 14.10.2020 9.10.2020 Zeposia Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/20/1442 12.10.2020 15.10.2020 Forxiga AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/795 19.10.2020 15.10.2020 Glyxambi Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/16/1146 20.10.2020 15.10.2020 IntronA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/99/127 16.10.2020 15.10.2020 Iscover Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/98/070 16.10.2020 15.10.2020 NovoEight Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/13/888 19.10.2020 15.10.2020 Noxafil Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/05/320 16.10.2020 15.10.2020 Rebif Merck Europe B.V. Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland EU/1/98/063 18.10.2020 15.10.2020 Truxima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/16/1167 16.10.2020 15.10.2020 ZALTRAP Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/12/814 16.10.2020 15.10.2020 Zessly Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1280 19.10.2020 16.10.2020 NovoSeven Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/96/006 19.10.2020 16.10.2020 Prometax Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/092 19.10.2020 19.10.2020 ALPROLIX Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/16/1098 20.10.2020 19.10.2020 Caelyx pegylated liposomal Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/96/011 20.10.2020 19.10.2020 Empliciti Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/16/1088 20.10.2020 19.10.2020 Eucreas Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/425 20.10.2020 19.10.2020 Exelon Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/066 20.10.2020 19.10.2020 Ifirmasta KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480 20.10.2020 19.10.2020 Invanz Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/02/216 21.10.2020 19.10.2020 Kisqali Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1221 20.10.2020 19.10.2020 Myocet liposomal Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/00/141 20.10.2020 19.10.2020 Olumiant Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1170 21.10.2020 19.10.2020 Poteligeo Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/18/1335 26.10.2020 19.10.2020 Tandemact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/366 25.10.2020 19.10.2020 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/09/605 20.10.2020 19.10.2020 Temozolomide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/10/615 20.10.2020 22.10.2020 Flucelvax Tetra Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands EU/1/18/1326 23.10.2020 22.10.2020 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 26.10.2020 22.10.2020 Mircera Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/07/400 24.10.2020 22.10.2020 Orfadin Swedish Orphan Biovitrum International AB 112 76 Stockholm, Sverige EU/1/04/303 26.10.2020 22.10.2020 Ribavirin Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/10/634 26.10.2020 22.10.2020 Stivarga Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/858 26.10.2020 22.10.2020 Sutent Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/06/347 26.10.2020 22.10.2020 Zelboraf Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/12/751 24.10.2020 22.10.2020 Zoledronic acid Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/12/800 23.10.2020 27.10.2020 ABILIFY MAINTENA Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland EU/1/13/882 28.10.2020 27.10.2020 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München, Deutschland EU/1/13/875 28.10.2020 27.10.2020 Faslodex AstraZeneca AB 151 85 Södertälje, Sverige EU/1/03/269 29.10.2020 27.10.2020 Gliolan medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/07/413 9.11.2020 27.10.2020 Kaletra AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/01/172 28.10.2020 27.10.2020 KANJINTI Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/18/1281 28.10.2020 27.10.2020 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 30.10.2020 27.10.2020 Xofigo Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/873 28.10.2020 27.10.2020 Zejula GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1235 28.10.2020 27.10.2020 Zirabev Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/18/1344 28.10.2020 28.10.2020 Biktarvy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/18/1289 2.11.2020 28.10.2020 Ifirmacombi KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/673 5.11.2020 28.10.2020 Udenyca ERA Consulting GmbH Lange Straße 70, 29664 Walsrode, Deutschland EU/1/18/1303 29.10.2020

— 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 27.10.2020 Ribavirin Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/10/634 28.10.2020

— 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 14.10.2020 EQUIOXX Audevard 42-46 rue Médéric, 92110 Clichy, France EU/2/08/083 15.10.2020 30.10.2020 Credelio Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/17/206 3.11.2020

— Withdrawal of a marketing authorisation (Article 38 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 29.10.2020 Zulvac 8 Bovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/105 2.11.2020

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.