Official Journal of the European Union

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.