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)
Date: 2020-11-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2020409EN.01000101.xml










27.11.2020   


EN


Official Journal of the European Union


C 409/1






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.