Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2020 to 30 November 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 453/01)

— 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 5.11.2020 Calquence acalabrutinib AstraZeneca AB 151 85 Södertälje, Sverige EU/1/20/1479 Capsule, hard L01XE 6.11.2020 16.11.2020 EXPAREL liposomal bupivacaine Pacira Ireland Ltd Unit 13, Classon House, Dundrum Business Park, Dundrum, Dublin 14, D14W9Y3, Ireland EU/1/20/1489 Prolonged-release dispersion for injection N01BB01 20.11.2020 16.11.2020 PHELINUN melphalan ADIENNE S.r.l.S.U. Via Galileo Galilei 19, 20867 Caponago (MB), Italia EU/1/20/1487 Powder and solvent for concentrate for solution for infusion L01AA03 17.11.2020 16.11.2020 Rivaroxaban Accord rivaroxaban Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/20/1488 Film-coated tablet B01AF01 17.11.2020 16.11.2020 Supemtek quadrivalent influenza vaccine (recombinant, prepared in cell culture) Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/20/1484 Solution for injection J07BB02 17.11.2020 18.11.2020 MenQuadfi Meningococcal group A, C, W and Y conjugate vaccine Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/20/1483 Solution for injection J07AH08 20.11.2020 18.11.2020 Nyvepria pegfilgrastim Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/20/1486 Solution for injection L03AA13 19.11.2020 18.11.2020 Obiltoxaximab SFL obiltoxaximab SFL Pharmaceuticals Deutschland GmbH Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland EU/1/20/1485 Concentrate for solution for infusion J06BB22 19.11.2020 19.11.2020 Oxlumo lumasiran Alnylam Netherlands B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland EU/1/20/1496 Solution for injection A16AX 23.11.2020 24.11.2020 Trecondi treosulfan medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/18/1351 Powder for solution for infusion L01AB02 26.11.2020

— 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 3.11.2020 Edistride AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1052 4.11.2020 3.11.2020 Forxiga AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/795 4.11.2020 3.11.2020 Kalydeco Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/12/782 4.11.2020 3.11.2020 Lynparza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/959 4.11.2020 3.11.2020 Tegsedi Akcea Therapeutics Ireland Ltd Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland EU/1/18/1296 4.11.2020 3.11.2020 Tepadina ADIENNE S.r.l. Via Galileo Galilei 19, 20867 Caponago (MB), Italia EU/1/10/622 5.11.2020 5.11.2020 Cinqaero Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/16/1125 9.11.2020 5.11.2020 Giotrif Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/13/879 6.11.2020 5.11.2020 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 9.11.2020 5.11.2020 Puregon Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/96/008 9.11.2020 5.11.2020 RXULTI Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland EU/1/18/1294 9.11.2020 5.11.2020 Trumenba Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/17/1187 9.11.2020 5.11.2020 Visudyne CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24, 17489 Greifswald, Deutschland EU/1/00/140 9.11.2020 5.11.2020 YERVOY Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/698 9.11.2020 10.11.2020 Fycompa Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/12/776 11.11.2020 10.11.2020 Myozyme Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/06/333 30.11.2020 10.11.2020 Nexium Control GlaxoSmithKline Dungarvan Limited Dungarvan, Co. Waterford, Ireland EU/1/13/860 11.11.2020 10.11.2020 Trecondi medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/18/1351 11.11.2020 16.11.2020 Anoro Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/898 18.11.2020 16.11.2020 Clopidogrel Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/08/465 17.11.2020 16.11.2020 DuoPlavin Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/10/619 17.11.2020 16.11.2020 EDURANT Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/11/736 17.11.2020 16.11.2020 Esbriet Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/11/667 17.11.2020 16.11.2020 Gilenya Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/677 17.11.2020 16.11.2020 Instanyl Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/09/531 18.11.2020 16.11.2020 Lopinavir/Ritonavir Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1067 20.11.2020 16.11.2020 Obizur Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/15/1035 24.11.2020 16.11.2020 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 17.11.2020 16.11.2020 Recarbrio Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/19/1420 18.11.2020 16.11.2020 Revlimid Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/07/391 17.11.2020 16.11.2020 TachoSil Takeda Austria GmbH St.-Peter-Strasse 25, 4020 Linz, Österreich EU/1/04/277 18.11.2020 16.11.2020 Talmanco Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1153 20.11.2020 16.11.2020 Tasigna Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/422 17.11.2020 16.11.2020 Temodal Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/98/096 18.11.2020 16.11.2020 Temozolomide SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/697 19.11.2020 16.11.2020 Temozolomide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/606 19.11.2020 16.11.2020 Tivicay ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/13/892 17.11.2020 16.11.2020 Velphoro Vifor Fresenius Medical Care Renal Pharma France 100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France EU/1/14/943 19.11.2020 16.11.2020 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/918 18.11.2020 18.11.2020 AUBAGIO Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/13/838 19.11.2020 18.11.2020 Benepali Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/15/1074 23.11.2020 18.11.2020 Biktarvy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/18/1289 19.11.2020 18.11.2020 Brintellix H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/13/891 20.11.2020 18.11.2020 Cufence Univar Solutions B.V. Schouwburgplein 30, Rotterdam, 3012 CL, Nederland EU/1/19/1365 20.11.2020 18.11.2020 Dovato ViiV Healthcare B.V. Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands EU/1/19/1370 20.11.2020 18.11.2020 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1222 20.11.2020 18.11.2020 Firdapse SERB S.A. Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België EU/1/09/601 25.11.2020 18.11.2020 Hemangiol Pierre Fabre Dermatologie 45 place Abel Gance, 92100 Boulogne, France EU/1/14/919 18.11.2020 18.11.2020 Imlygic Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1064 20.11.2020 18.11.2020 Kisplyx Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/16/1128 23.11.2020 18.11.2020 Lenvima Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/15/1002 23.11.2020 18.11.2020 Myfenax Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/438 19.11.2020 18.11.2020 Nivestim Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/10/631 19.11.2020 18.11.2020 Orkambi Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/15/1059 19.11.2020 18.11.2020 Plavix Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/98/069 19.11.2020 18.11.2020 Pregabalin Pfizer Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/14/916 24.11.2020 18.11.2020 Synagis AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/99/117 19.11.2020 18.11.2020 Trulicity Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/956 1.12.2020 18.11.2020 Ultomiris Alexion Europe SAS 103-105 Rue Anatole France, 92300 Levallois-Perret, France EU/1/19/1371 19.11.2020 18.11.2020 VeraSeal Instituto Grifols, S.A. Can Guasc, 2 — Parets del Vallès, 08150 Barcelona, Espaňa EU/1/17/1239 3.12.2020 18.11.2020 Viramune Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/97/055 23.11.2020 19.11.2020 Kevzara Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1196 20.11.2020 20.11.2020 Bretaris Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/781 23.11.2020 20.11.2020 Cetrotide Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/99/100 23.11.2020 20.11.2020 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 23.11.2020 20.11.2020 Eklira Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/778 23.11.2020 20.11.2020 Enurev Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/789 23.11.2020 20.11.2020 Flixabi Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/16/1106 24.11.2020 20.11.2020 Kanuma Alexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-Perret, France EU/1/15/1033 23.11.2020 20.11.2020 Luxturna Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1331 23.11.2020 20.11.2020 Lyrica Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/04/279 7.12.2020 20.11.2020 Ninlaro Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/16/1094 24.11.2020 20.11.2020 Olumiant Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1170 23.11.2020 20.11.2020 Oncaspar Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/15/1070 24.11.2020 20.11.2020 Onpattro Alnylam Netherlands B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland EU/1/18/1320 24.11.2020 20.11.2020 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 23.11.2020 20.11.2020 Privigen CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/08/446 6.12.2020 20.11.2020 Rasagiline Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1090 24.11.2020 20.11.2020 Spherox CO.DON AG Warthestraße 21, 14513 Teltow, Deutschland EU/1/17/1181 23.11.2020 20.11.2020 Tremfya Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/17/1234 24.11.2020 24.11.2020 Comtan Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/98/081 26.11.2020 24.11.2020 Desloratadine ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/11/746 3.12.2020 24.11.2020 Gardasil 9 MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/15/1007 26.11.2020 24.11.2020 GONAL-f Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/95/001 25.11.2020 24.11.2020 Irbesartan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/576 25.11.2020 24.11.2020 Lacosamide UCB UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/19/1383 25.11.2020 24.11.2020 Ongentys Bial — Portela & Ca, SA À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal EU/1/15/1066 4.12.2020 24.11.2020 Strensiq Alexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-Perret, France EU/1/15/1015 25.11.2020 24.11.2020 Tecfidera Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/13/837 3.12.2020 25.11.2020 Briviact UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/15/1073 4.12.2020 25.11.2020 Dupixent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1229 26.11.2020 25.11.2020 Febuxostat Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1194 27.11.2020 25.11.2020 Feraccru Norgine B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland EU/1/15/1075 26.11.2020 25.11.2020 Kalydeco Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/12/782 26.11.2020 25.11.2020 Prevenar 13 Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/09/590 26.11.2020 25.11.2020 Symkevi Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/18/1306 26.11.2020 25.11.2020 Yescarta Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland EU/1/18/1299 26.11.2020

— 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 3.11.2020 Panretin Amdipharm Limited 3 Burlington Road, Dublin 4, D04 RD68, IRELAND EU/1/00/149 4.11.2020 5.11.2020 Sebivo Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/388 9.11.2020 20.11.2020 Alpivab BioCryst Ireland Limited Atlantic Avenue, Westpark Business Campus, Shannon, V14 YX01, Ireland EU/1/18/1269 24.11.2020 24.11.2020 Qutavina EuroGenerics Holdings BV Locatellikade 1, 1076AZ Amsterdam, Nederland EU/1/20/1463 26.11.2020

— 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 10.11.2020 Librela bedinvetmab Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/20/261 Solution for injection QN02BG91 11.11.2020 10.11.2020 OvuGel triptorelin acetate Vetoquinol S.A. Magny-Vernois, 70200 Lure, France EU/2/20/260 Vaginal gel QH01CA97 12.11.2020

— 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 4.11.2020 CYTOPOINT Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/205 5.11.2020 4.11.2020 ReproCyc ParvoFLEX Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/19/237 6.11.2020 10.11.2020 ProZinc Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/2/13/152 26.11.2020 20.11.2020 Innovax-ND-IBD Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/17/213 29.11.2020

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.