Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 31 January 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-02-26
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_2021067EN.01000501.xml










26.2.2021   


EN


Official Journal of the European Union


C 67/5






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 31 January 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 67/02)
—   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




7.1.2021


ELZONRIS


tagraxofusp







Stemline Therapeutics B.V.




Prins Bernhardplein 200, 1097 JB Amsterdam, Noord-Holland, Nederland






EU/1/20/1504


Concentrate for solution for infusion


L01XX67


13.1.2021




7.1.2021


Roclanda


Latanoprost/netarsudil







Aerie Pharmaceuticals Ireland Ltd




Athlone Business and Technology Park, Dublin Road, Garrycastle, Athlone, Co Westmeath, N37 DW40, Ireland






EU/1/20/1502


Eye drops, solution


S01EE51


8.1.2021




7.1.2021


Xofluza


baloxavir marboxil







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/20/1500


Film-coated tablet


J05AX25


8.1.2021




11.1.2021


Onbevzi


bevacizumab







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/20/1499


Concentrate for solution for infusion


L01XC07


13.1.2021




14.1.2021


Ervebo


Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live)







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/19/1392


Solution for injection


J07BX02


19.1.2021




18.1.2021


Enhertu


trastuzumab deruxtecan







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


Powder for concentrate for solution for infusion


L01XC41


20.1.2021




—   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




7.1.2021


Gamifant







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






—


8.1.2021




—   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




7.1.2021


Dukoral







Valneva Sweden AB




105 21 Stockholm, Sverige






EU/1/03/263


8.1.2021




7.1.2021


Emgality







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/18/1330


8.1.2021




7.1.2021


Holoclar







Holostem Terapie Avanzate S.r.l.




Via Glauco Gottardi 100, Modena, MO 41125, Italia






EU/1/14/987


8.1.2021




7.1.2021


Incresync







Takeda Pharma A/S




Dybendal Alle 10, 2630 Taastrup, Danmark






EU/1/13/842


11.1.2021




7.1.2021


Mayzent







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/19/1414


8.1.2021




7.1.2021


Ofev







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/979


8.1.2021




7.1.2021


Ondexxya







Alexion Europe SAS




103-105 Rue Anatole France, 92300 Levallois-Perret, France






EU/1/18/1345


21.1.2021




7.1.2021


Temybric Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/19/1378


25.1.2021




7.1.2021


Truvada







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/04/305


8.1.2021




7.1.2021


Vipdomet







Takeda Pharma A/S




Dybendal Alle 10, 2630 Taastrup, Danmark






EU/1/13/843


12.1.2021




7.1.2021


Vipidia







Takeda Pharma A/S




Dybendal Alle 10, 2630 Taastrup, Danmark






EU/1/13/844


12.1.2021




7.1.2021


YERVOY







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland






EU/1/11/698


10.1.2021




8.1.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


8.1.2021




11.1.2021


Bydureon







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/11/696


13.1.2021




11.1.2021


Byetta







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/06/362


13.1.2021




11.1.2021


CRYSVITA







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/17/1262


25.1.2021




11.1.2021


Dovprela







Mylan IRE Healthcare Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Ireland






EU/1/20/1437


12.1.2021




11.1.2021


Dupixent







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/17/1229


12.1.2021




11.1.2021


Eliquis







Bristol-Myers Squibb/Pfizer EEIG




Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland






EU/1/11/691


13.1.2021




11.1.2021


Esmya







Gedeon Richter Plc.




Gyömrői út 19-21., 1103 Budapest, Magyarország






EU/1/12/750


13.1.2021




11.1.2021


HBVAXPRO







MSD VACCINS




162 avenue Jean Jaurès, 69007 Lyon, France






EU/1/01/183


13.1.2021




11.1.2021


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


13.1.2021




11.1.2021


Invokana







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/884


12.1.2021




11.1.2021


Naglazyme







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork P43 R298, Ireland






EU/1/05/324


12.1.2021




11.1.2021


Neupro







UCB Pharma S.A.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België






EU/1/05/331


25.1.2021




11.1.2021


Ocaliva







Intercept Pharma International Limited




Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland






EU/1/16/1139


13.1.2021




11.1.2021


Ocrevus







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/17/1231


12.1.2021




11.1.2021


Pradaxa







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/08/442


12.1.2021




11.1.2021


Silapo







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/07/432


12.1.2021




11.1.2021


Sirturo







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/901


12.1.2021




11.1.2021


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/08/494


13.1.2021




11.1.2021


Tenofovir disoproxil Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1129


13.1.2021




11.1.2021


Tivicay







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/13/892


13.1.2021




11.1.2021


Ulipristal Acetate Gedeon Richter







Gedeon Richter Plc.




Gyömrői út 19-21., 1103 Budapest, Magyarország






EU/1/18/1309


13.1.2021




11.1.2021


Zonegran







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/04/307


13.1.2021




14.1.2021


Amlodipine/Valsartan Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1092


21.1.2021




14.1.2021


Dovprela







Mylan IRE Healthcare Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Ireland






EU/1/20/1437


15.1.2021




14.1.2021


NUCEIVA







Evolus Pharma Limited




70 Sir John Rogerson’s Quay, Dublin 2, Ireland






EU/1/19/1364


15.1.2021




14.1.2021


Odefsey







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1112


15.1.2021




14.1.2021


Renagel







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/99/123


21.1.2021




14.1.2021


Spinraza







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/17/1188


28.1.2021




14.1.2021


Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1127


16.1.2021




14.1.2021


Trimbow







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/17/1208


15.1.2021




14.1.2021


Viread







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/01/200


15.1.2021




14.1.2021


Vokanamet







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/918


18.1.2021




14.1.2021


Zykadia







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/15/999


15.1.2021




18.1.2021


Caelyx pegylated liposomal







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/96/011


19.1.2021




18.1.2021


Doptelet







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/19/1373


19.1.2021




18.1.2021


Hycamtin







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/96/027


20.1.2021




21.1.2021


Bavencio







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1214


22.1.2021




21.1.2021


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


25.1.2021




21.1.2021


Lutathera







Advanced Accelerator Applications




20 rue Diesel, 01630 Saint-Genis-Pouilly, France






EU/1/17/1226


22.1.2021




21.1.2021


Mimpara







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/04/292


25.1.2021




21.1.2021


Nordimet







Nordic Group B.V.




Siriusdreef 41, 2132 WT Hoofddorp, Nederland






EU/1/16/1124


30.1.2021




21.1.2021


Xarelto







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/08/472


22.1.2021




22.1.2021


Baraclude







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland






EU/1/06/343


26.1.2021




22.1.2021


Darunavir Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1140


1.2.2021




22.1.2021


Imraldi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/17/1216


26.1.2021




22.1.2021


Nplate







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/08/497


25.1.2021




22.1.2021


Ribavirin Teva Pharma BV







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/527


26.1.2021




22.1.2021


Rinvoq







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


25.1.2021




22.1.2021


Rydapt







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/17/1218


25.1.2021




22.1.2021


Trazimera







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België






EU/1/18/1295


25.1.2021




22.1.2021


Vizimpro







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België






EU/1/19/1354


25.1.2021




22.1.2021


Zinforo







Pfizer Ireland Pharmaceuticals




Operations Support Group, Ringaskiddy, County Cork, Ireland






EU/1/12/785


29.1.2021




22.1.2021


Zoledronic acid Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/12/771


27.1.2021




29.1.2021


Ambrisentan Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/19/1368


2.2.2021




29.1.2021


Atazanavir Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1091


1.2.2021




29.1.2021


Cubicin







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/05/328


2.2.2021




29.1.2021


Desloratadine Actavis







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/11/745


1.2.2021




29.1.2021


Ganfort







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, County Mayo, Ireland






EU/1/06/340


1.2.2021




29.1.2021


Iscover







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/070


1.2.2021




29.1.2021


Ivabradine Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1144


1.2.2021




29.1.2021


Leganto







UCB Pharma S.A.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België






EU/1/11/695


4.2.2021




29.1.2021


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


1.2.2021




29.1.2021


Levetiracetam ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/11/702


1.2.2021




29.1.2021


Menveo







GSK Vaccines S.r.l.




Via Fiorentina 1, 53100 Siena, Italia






EU/1/10/614


9.2.2021




29.1.2021


Neoclarityn







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/00/161


2.2.2021




29.1.2021


Plavix







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/069


1.2.2021




29.1.2021


Yargesa







Piramal Critical Care B.V.




Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland






EU/1/17/1176


2.2.2021




29.1.2021


Zepatier







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/16/1119


2.2.2021




—   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




11.1.2021


ViraferonPeg







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/00/132


15.1.2021




—   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




6.1.2021


Enteroporc Coli


Neonatal piglet colibacillosis vaccine (recombinant, inactivated)







IDT Biologika GmbH




Am Pharmapark, 06861 Dessau-Rosslau, Deutschland






EU/2/20/268


Suspension for injection


Pending


8.1.2021




6.1.2021


NexGard Combo


esafoxolaner/eprinomectin/praziquantel







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/267


Spot-on solution


QP54AA54


7.1.2021




—   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




14.1.2021


Profender







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/05/054


15.1.2021




21.1.2021


Procox







VETOQUINOL S.A.




Magny-Vernois, 70200 Lure, France






EU/2/11/123


22.1.2021




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.