Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2020 to 31 August 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 318/01)

— 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 19.8.2020 Aybintio bevacizumab Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/20/1454 Concentrate for solution for infusion L01XC07 20.8.2020 19.8.2020 Bavencio avelumab Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1214 Concentrate for solution for infusion L01XC31 25.8.2020 19.8.2020 Gencebok caffeine citrate Gennisium Pharma Faculté Cochin — Paris Biotech Santé, 24 rue du Faubourg St Jacques, 75014 Paris, France EU/1/20/1465 Solution for infusion N06BC01 20.8.2020 19.8.2020 Methylthioninium chloride Cosmo methylthioninium chloride Cosmo Technologies Ltd Riverside II, Sir John Rogerson’s Quay, Dublin 2, Ireland EU/1/20/1470 Prolonged-release tablet V04CX 20.8.2020 21.8.2020 Kaftrio ivacaftor / tezacaftor / elexacaftor Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/20/1468 Film-coated tablet R07AX32 21.8.2020 25.8.2020 BLENREP belantamab mafodotin GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/20/1474 Powder for concentrate for solution for infusion L01XC39 26.8.2020 25.8.2020 Idefirix imlifidase Hansa Biopharma AB P.O. Box 785, 220 07 Lund, Sverige EU/1/20/1471 Powder for concentrate for solution for infusion L04AA 1.9.2020 27.8.2020 Livogiva teriparatide Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/20/1462 Solution for injection H05AA02 28.8.2020 27.8.2020 Qutavina teriparatide EuroGenerics Holdings BV Locatellikade 1, 1076AZ Amsterdam, Nederland EU/1/20/1463 Solution for injection H05AA02. 31.8.2020 28.8.2020 Cabazitaxel Accord cabazitaxel Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/20/1448 Concentrate for solution for infusion L01CD04 31.8.2020

— 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 6.8.2020 Panretin Amdipharm Limited 3 Burlington Road, Dublin 4, D04 RD68, IRELAND EU/1/00/149 7.8.2020 6.8.2020 Pramipexole Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/11/728 10.8.2020 6.8.2020 Raxone Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Straße 8, 79539 Lörrach, Deutschland EU/1/15/1020 12.8.2020 6.8.2020 Zavicefta Pfizer Ireland Pharmaceuticals Operations Support Group, Ringaskiddy, County Cork, Ireland EU/1/16/1109 11.8.2020 10.8.2020 Colobreathe Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/747 14.8.2020 10.8.2020 Fotivda EUSA Pharma (Netherlands) B.V. Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland EU/1/17/1215 3.9.2020 10.8.2020 Inflectra Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/13/854 11.8.2020 10.8.2020 Jylamvo Therakind (Europe) Limited 3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland EU/1/17/1172 24.8.2020 10.8.2020 Levetiracetam Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/701 17.8.2020 10.8.2020 Nucala GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/15/1043 14.8.2020 10.8.2020 Onivyde pegylated liposomal Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/16/1130 11.8.2020 10.8.2020 Pemetrexed Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/15/1057 10.8.2020 13.8.2020 Apealea Oasmia Pharmaceutical AB Vallongatan 1, 75228 Uppsala, Sverige EU/1/18/1292 24.8.2020 13.8.2020 Armisarte Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland EU/1/15/1063 22.8.2020 13.8.2020 Cresemba Basilea Pharmaceutica Deutschland GmbH Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland EU/1/15/1036 14.8.2020 13.8.2020 Duloxetine Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1028 17.8.2020 13.8.2020 Imatinib Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/13/845 17.8.2020 13.8.2020 Qtrilmet AstraZeneca AB 151 85 Södertälje, Sverige EU/1/19/1401 17.8.2020 13.8.2020 Twynsta Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/10/648 14.8.2020 17.8.2020 Circadin RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux, 75002 Paris, France EU/1/07/392 20.8.2020 19.8.2020 Elocta Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/15/1046 21.8.2020 19.8.2020 Emend Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/03/262 24.8.2020 19.8.2020 IDELVION CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/16/1095 24.8.2020 19.8.2020 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 24.8.2020 19.8.2020 Pemetrexed medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/15/1038 20.8.2020 19.8.2020 Pemetrexed Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1037 28.8.2020 19.8.2020 Praluent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/15/1031 20.8.2020 19.8.2020 Skilarence Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/17/1201 26.8.2020 19.8.2020 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 20.8.2020 21.8.2020 Kalydeco Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/12/782 21.8.2020 25.8.2020 Aimovig Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1293 3.9.2020 25.8.2020 Axumin Blue Earth Diagnostics Ireland Ltd 6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland EU/1/17/1186 26.8.2020 25.8.2020 Ebymect AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1051 1.9.2020 25.8.2020 Epclusa Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1116 26.8.2020 25.8.2020 Esperoct Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/19/1374 26.8.2020 25.8.2020 Latuda Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.p.A. Viale Amelia 70, 00181 Roma, Italia EU/1/14/913 4.9.2020 25.8.2020 Ninlaro Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/16/1094 1.9.2020 25.8.2020 Ravicti Immedica Pharma AB SE-113 29 Stockholm, Sverige EU/1/15/1062 26.8.2020 25.8.2020 RotaTeq MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/348 27.8.2020 25.8.2020 Shingrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/18/1272 26.8.2020 25.8.2020 Vemlidy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1154 26.8.2020 25.8.2020 VITRAKVI Bayer AG D-51368 Leverkusen, Deutschland EU/1/19/1385 26.8.2020 25.8.2020 Votubia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/710 25.8.2020 27.8.2020 Atriance Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/403 27.8.2020 27.8.2020 Betaferon Bayer AG D-51368 Leverkusen, Deutschland EU/1/95/003 28.8.2020 27.8.2020 Fortacin Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/13/881 3.9.2020 27.8.2020 Imatinib Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland EU/1/13/825 28.8.2020 27.8.2020 Imfinzi AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1322 31.8.2020 27.8.2020 NovoThirteen Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/12/775 28.8.2020 27.8.2020 Skyrizi AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/19/1361 28.8.2020 28.8.2020 Actraphane Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/229 31.8.2020 28.8.2020 Actrapid Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/230 31.8.2020 28.8.2020 Eurartesim Alfasigma S.p.A. Via Ragazzi del '99, n.5, 40133 Bologna, Italia EU/1/11/716 31.8.2020 28.8.2020 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 2.9.2020 28.8.2020 Olanzapine Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/08/475 31.8.2020 28.8.2020 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/06/380 1.9.2020 28.8.2020 Reyataz Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/03/267 31.8.2020 28.8.2020 Vyxeos liposomal Jazz Pharmaceuticals Ireland Ltd 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland EU/1/18/1308 31.8.2020 28.8.2020 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 31.8.2020

— 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 14.8.2020 Qtrilmet AstraZeneca AB 151 85 Södertälje, Sverige EU/1/19/1401 17.8.2020

— 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 5.8.2020 Econor Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/98/010 6.8.2020 5.8.2020 Halocur Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/99/013 10.8.2020 12.8.2020 ECOPORC SHIGA Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/13/149 14.8.2020 12.8.2020 Nobilis IB Primo QX Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/14/174 14.8.2020 12.8.2020 Respiporc Flu3 Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/09/103 31.8.2020 12.8.2020 RESPIPORC FLUpan H1N1 Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/17/209 31.8.2020 12.8.2020 Simparica Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/15/191 17.8.2020 18.8.2020 Suvaxyn PRRS MLV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/215 21.8.2020 20.8.2020 BLUEVAC BTV CZ Veterinaria, S.A. La Relva s/n — Torneiros, 36410 Porriño, España EU/2/11/122 26.8.2020 20.8.2020 Zycortal Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/15/189 26.8.2020 28.8.2020 VEPURED Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/17/214 1.9.2020

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.