Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2020 to 30 September 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 367/02)

— 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 17.9.2020 Arsenic trioxide medac arsenic trioxide medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/20/1475 Concentrate and solvent for solution for infusion L01XX27 18.9.2020 24.9.2020 AYVAKYT avapritinib Blueprint Medicines (Netherlands) B.V. Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland EU/1/20/1473 Film-coated tablet L01EX18 25.9.2020 24.9.2020 Equidacent bevacizumab Centus Biotherapeutics Europe Limited 6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland EU/1/20/1472 Concentrate for solution for infusion L01XC07 25.9.2020 24.9.2020 Fampridine Accord fampridine Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/20/1477 Prolonged-release tablet N07XX07 29.9.2020 24.9.2020 Jyseleca filgotinib Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1480 Film-coated tablet L04AA45 25.9.2020 24.9.2020 Zynrelef bupivacaine/meloxicam Heron Therapeutics, B.V. Herengracht 500, 1017 CB Amsterdam, Nederland EU/1/20/1478 Prolonged-release solution for injection Pending 25.9.2020

— 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 3.9.2020 HyQvia Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/13/840 5.9.2020 3.9.2020 Vimpat UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/08/470 4.9.2020 15.9.2020 ADCETRIS Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/12/794 16.9.2020 15.9.2020 CellCept Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/96/005 16.9.2020 15.9.2020 Ervebo Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/19/1392 16.9.2020 15.9.2020 Hepsera Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/03/251 16.9.2020 15.9.2020 Herzuma Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1257 16.9.2020 15.9.2020 JETREA Inceptua AB Gustavslundsv. 143, 16751 Bromma, Sverige EU/1/13/819 16.9.2020 15.9.2020 Levetiracetam Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/11/712 16.9.2020 15.9.2020 Levetiracetam Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland EU/1/11/713 16.9.2020 15.9.2020 Mvasi Amgen Technology (Ireland) UC Pottery Road, Dun Laoghaire, Co. Dublin, Ireland EU/1/17/1246 17.9.2020 15.9.2020 Prasugrel Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1273 16.9.2020 15.9.2020 Simbrinza Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/933 16.9.2020 15.9.2020 Stayveer Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/832 16.9.2020 15.9.2020 Thalidomide Celgene Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/08/443 16.9.2020 15.9.2020 Tremfya Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/17/1234 16.9.2020 17.9.2020 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 18.9.2020 17.9.2020 Dengvaxia Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/18/1338 18.9.2020 17.9.2020 Episalvan Amryt GMBH Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland EU/1/15/1069 29.9.2020 17.9.2020 Genvoya Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/15/1061 18.9.2020 17.9.2020 Hetlioz Vanda Pharmaceuticals Netherlands B.V., Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland EU/1/15/1008 19.9.2020 17.9.2020 Ivozall ORPHELIA Pharma SAS 85 boulevard Saint-Michel, 75005 Paris, France EU/1/19/1396 29.9.2020 17.9.2020 Kovaltry Bayer AG D-51368 Leverkusen, Deutschland EU/1/15/1076 21.9.2020 17.9.2020 Lumark IDB Holland B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland EU/1/15/1013 21.9.2020 17.9.2020 Tadalafil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/14/961 18.9.2020 17.9.2020 Tyverb Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/440 18.9.2020 17.9.2020 Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/12/779 21.9.2020 24.9.2020 Bavencio Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1214 25.9.2020 24.9.2020 Cinacalcet Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1054 28.9.2020 24.9.2020 Edistride AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1052 28.9.2020 24.9.2020 EndolucinBeta ITM Medical Isotopes GmbH Lichtenbergstraße 1, 85748 Garching, Deutschland EU/1/16/1105 28.9.2020 24.9.2020 Eylea Bayer AG D-51368 Leverkusen, Deutschland EU/1/12/797 25.9.2020 24.9.2020 Inbrija Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland EU/1/19/1390 5.10.2020 24.9.2020 Incruse Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/922 2.10.2020 24.9.2020 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 28.9.2020 24.9.2020 Levetiracetam Actavis Group Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland EU/1/11/738 29.10.2020 24.9.2020 Lymphoseek Navidea Biopharmaceuticals Europe Ltd. Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland EU/1/14/955 25.9.2020 24.9.2020 Lynparza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/959 28.9.2020 24.9.2020 Olazax Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/597 29.9.2020 24.9.2020 Plegridy Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/14/934 28.9.2020 24.9.2020 Revlimid Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/07/391 28.9.2020 24.9.2020 Saxenda Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/15/992 28.9.2020 24.9.2020 Spectrila medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/15/1072 25.9.2020 24.9.2020 Vaxelis MCM Vaccine B.V. Robert Boyleweg 4, 2333 CG Leiden, Nederland EU/1/15/1079 9.10.2020 24.9.2020 Victoza Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/09/529 28.9.2020 24.9.2020 Xermelo Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/17/1224 2.10.2020 24.9.2020 Yondelis Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España EU/1/07/417 28.9.2020 24.9.2020 Zalviso Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland EU/1/15/1042 5.10.2020 30.9.2020 Aripiprazole Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/15/1045 1.10.2020 30.9.2020 Blitzima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1205 1.10.2020 30.9.2020 CRYSVITA Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/17/1262 2.10.2020 30.9.2020 Eptifibatide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/15/1065 1.10.2020 30.9.2020 Erelzi Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1195 1.10.2020 30.9.2020 Extavia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/454 1.10.2020 30.9.2020 Exviera AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/983 2.10.2020 30.9.2020 Febuxostat Krka KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/18/1347 1.10.2020 30.9.2020 Fiasp Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/16/1160 1.10.2020 30.9.2020 Herceptin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/00/145 1.10.2020 30.9.2020 Icandra Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/484 1.10.2020 30.9.2020 Kyntheum Leo Pharma A/S Industriparken 55, 2750 Ballerup, Danmark EU/1/16/1155 2.10.2020 30.9.2020 Mepsevii Ultragenyx Germany GmbH Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland EU/1/18/1301 1.10.2020 30.9.2020 Neparvis Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/16/1103 1.10.2020 30.9.2020 Ozempic Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/17/1251 1.10.2020 30.9.2020 Pemetrexed Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/15/1057 2.10.2020 30.9.2020 ReFacto AF Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/99/103 1.10.2020 30.9.2020 Rolufta Ellipta GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1174 2.10.2020 30.9.2020 Simulect Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/084 1.10.2020 30.9.2020 Temozolomide HEXAL Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland EU/1/10/616 1.10.2020 30.9.2020 Temozolomide Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/10/617 1.10.2020 30.9.2020 Xigduo AstraZeneca AB 151 85 Södertälje, Sverige EU/1/13/900 1.10.2020 30.9.2020 Zomarist Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/483 1.10.2020

— 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 24.9.2020 Vepacel Ology Bioservices Ireland LTD Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland EU/1/12/752 2.10.2020

— 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 16.9.2020 Increxxa tulathromycin Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/20/258 Solution for injection QJ01FA94 17.9.2020 16.9.2020 Innovax-ND-ILT Marek's disease vaccine, Newcastle disease vaccine & infectious laryngotracheitis vaccine (live recombinant) Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/20/256 Concentrate and solvent for suspension for injection QI01AD17 17.9.2020 16.9.2020 Tulinovet tulathromycin V.M.D.n.v. Hoge Mauw 900, 2370 Arendonk, Belgïe EU/2/20/257 Solution for injection QJ01FA94 17.9.2020 18.9.2020 MHYOSPHERE PCV ID Mycoplasma hyopneumoniae and porcine circovirus vaccine (inactivated, recombinant) Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/20/259 Emulsion for injection QI09AL08 21.9.2020

— 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 8.9.2020 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/07/079 22.9.2020 16.9.2020 Osurnia Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/14/170 17.9.2020 16.9.2020 Suvaxyn Circo + MH RTU Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/15/190 17.9.2020 30.9.2020 Imrestor Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/15/193 1.10.2020 30.9.2020 Vectra Felis Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/14/165 1.10.2020

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.