Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2020 to 31 January 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 66/01)

— Issuing of a marketing authorization (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 authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 9.1.2020 Clopidogrel/Acetylsalicylic acid Mylan clopidogrel/acetylsalicylic acid Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/19/1395 Film-coated tablet B01AC30 13.1.2020 9.1.2020 Deferasirox Accord deferasirox Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/19/1412 Film-coated tablet V03AC03 13.1.2020 9.1.2020 Isturisa osilodrostat Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/19/1407 Film-coated tablet H02CA02 13.1.2020 9.1.2020 TAVLESSE fostamatinib Rigel Pharmaceuticals B.V. Avenue Ceramique 223, 6621 KX Maastricht, Nederland EU/1/19/1405 Film-coated tablet B02BX09 13.1.2020 13.1.2020 Mayzent siponimod Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/19/1414 Film-coated tablet L04AA42 15.1.2020 16.1.2020 Polivy polatuzumab vedotin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/19/1388 Powder for concentrate for solution for infusion L01XC37 20.1.2020 16.1.2020 Sunosi solriamfetol Jazz Pharmaceuticals Ireland Ltd 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland EU/1/19/1408 Film-coated tablet N06BA14 20.1.2020

— Modification of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 9.1.2020 Akynzeo Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland EU/1/15/1001 13.1.2020 9.1.2020 Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Slunná 16, 61700 Brno, Česká republika EU/1/09/541 13.1.2020 9.1.2020 Cymbalta Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/296 13.1.2020 9.1.2020 Elebrato Ellipta GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1237 13.1.2020 9.1.2020 Kigabeq ORPHELIA Pharma SAS 85 boulevard Saint-Michel, 75005 Paris, France EU/1/18/1302 13.1.2020 9.1.2020 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/901 13.1.2020 9.1.2020 Sivextro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/991 13.1.2020 9.1.2020 Taxotere Sanofi Mature IP 54 Rue de la Boetie, 75008, Paris, FRANCE EU/1/95/002 13.1.2020 9.1.2020 Tecfidera Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/13/837 13.1.2020 13.1.2020 Abasaglar Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/944 15.1.2020 13.1.2020 Caprelsa Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/11/749 15.1.2020 13.1.2020 Darunavir Krka d.d. Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1248 15.1.2020 13.1.2020 Dexdor Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/11/718 15.1.2020 13.1.2020 Hizentra CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/11/687 15.1.2020 13.1.2020 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/00/152 15.1.2020 13.1.2020 Invokana Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/884 15.1.2020 13.1.2020 Orbactiv Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/15/989 15.1.2020 13.1.2020 Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1129 15.1.2020 13.1.2020 Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1127 15.1.2020 13.1.2020 Vaxelis MCM Vaccine B.V. Robert Boyleweg 4, 2333 CG Leiden, Nederland EU/1/15/1079 16.1.2020 13.1.2020 Yescarta Kite Pharma EU B.V. Science Park 408, 1098 XH Amsterdam, Nederland EU/1/18/1299 15.1.2020 13.1.2020 Zepatier Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/16/1119 15.1.2020 16.1.2020 Gardasil 9 MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/15/1007 20.1.2020 16.1.2020 Humalog Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/96/007 20.1.2020 16.1.2020 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134 20.1.2020 16.1.2020 Lemtrada Sanofi Belgium Leonardo Da Vincilaan 19, B-1831 Diegem, België EU/1/13/869 20.1.2020 16.1.2020 Liprolog Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/01/195 20.1.2020 16.1.2020 Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/988 20.1.2020 16.1.2020 Prolia Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/10/618 20.1.2020 16.1.2020 Semglee Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1270 20.1.2020 16.1.2020 Toujeo Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133 20.1.2020 16.1.2020 Viread Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/01/200 20.1.2020 16.1.2020 Zirabev Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/18/1344 20.2.2020 17.1.2020 Verzenios Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/18/1307 21.1.2020 20.1.2020 Darzalex Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/16/1101 22.1.2020 20.1.2020 Eurartesim Alfasigma S.p.A. Via Ragazzi del ‘99, n.5, 40133 Bologna, Italia EU/1/11/716 22.1.2020 20.1.2020 Fertavid Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/09/510 22.1.2020 20.1.2020 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 22.1.2020 20.1.2020 Stelara Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/08/494 22.1.2020 20.1.2020 YERVOY Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/698 22.1.2020 23.1.2020 Bydureon AstraZeneca AB 151 85 Södertälje, Sverige EU/1/11/696 27.1.2020 23.1.2020 Cyramza Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/957 27.1.2020 23.1.2020 Hemlibra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/18/1271 28.1.2020 23.1.2020 Ketoconazole HRA HRA Pharma Rare Diseases 200 avenue de Paris, 92320 Chatillon, France EU/1/14/965 27.1.2020 23.1.2020 Menveo GSK Vaccines S.r.l. Via Fiorentina 1, 53100 Siena, Italia EU/1/10/614 27.1.2020 23.1.2020 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/901 27.1.2020 23.1.2020 Xeristar Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/297 27.1.2020 23.1.2020 Zynquista Navigant Germany GmbH Albrechtstrasse 10c, 10117 Berlin, Deutschland EU/1/19/1363 27.1.2020 27.1.2020 Delstrigo Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1333 29.1.2020 27.1.2020 Erleada Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/18/1342 29.1.2020 27.1.2020 Rubraca Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House – Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland EU/1/17/1250 29.1.2020 31.1.2020 Otezla Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/14/981 4.2.2020 31.1.2020 Panretin Eisai GmbH Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland EU/1/00/149 4.2.2020 31.1.2020 Xeljanz Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1178 4.2.2020 31.1.2020 Zejula GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1235 4.2.2020

— Withdrawal of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 13.1.2020 Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Slunná 16, 61700 Brno, Česká republika EU/1/09/541 15.1.2020 23.1.2020 Fertavid Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/09/510 27.1.2020 23.1.2020 Varuby TESARO Bio Netherlands B.V. Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht, Nederland EU/1/17/1180 27.1.2020

— Suspension of a marketing authorization (Article 20 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 authorization Number of the entry in the Community Register Date of notification 17.1.2020 Picato LEO Laboratories Ltd 285 Cashel Road, Crumlin, Dublin 12, Ireland EU/1/12/796 21.1.2020

— Issuing of a marketing authorization (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 authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 15.1.2020 Stelfonta tigilanol tiglate QBiotics Netherlands B.V. Prinses Margrietplantsoen 33, 2595 AM Den Haag, Nederland EU/2/19/248 Solution for injection QL01XX91 17.1.2020 28.1.2020 Aservo EquiHaler ciclesonide Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/19/249 Inhalation solution QR03BA08 30.1.2020

— Modification of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 15.1.2020 BTVPUR Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/2/10/113 17.1.2020 15.1.2020 Coliprotec F4 Prevtec Microbia GmbH Geyerspergerstr 27, 80689 München, Deutschland EU/2/14/180 17.1.2020 15.1.2020 Nobilis IB 4-91 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/98/006 17.1.2020 15.1.2020 Pirsue Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/00/027 17.1.2020 15.1.2020 ProteqFlu Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/03/037 17.1.2020 15.1.2020 ProteqFlu-Te Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/03/038 17.1.2020 15.1.2020 Proteq West Nile Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/2/11/129 17.1.2020 15.1.2020 Purevax Rabies Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/2/10/117 17.1.2020 15.1.2020 Semintra Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/146 17.1.2020 15.1.2020 Zulvac SBV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/178 17.1.2020 20.1.2020 Onsior Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/08/089 22.1.2020 27.1.2020 ERAVAC Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/16/199 29.1.2020 27.1.2020 Kexxtone Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/12/145 29.1.2020

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.