Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2020 to 31 July 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 285/01)

— 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 1.7.2020 Mvabea Ebola vaccine (MVA-BN-Filo [recombinant]) Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1445 Suspension for injection J07BX02 6.7.2020 1.7.2020 Zabdeno Ebola vaccine (Ad26.ZEBOV-GP [recombinant]) Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1444 Suspension for injection J07BX02 6.7.2020 3.7.2020 Enerzair Breezhaler indacaterol/glycopyrronium/mometasone furoate Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1438 Inhalation powder, hard capsule R03AL12 6.7.2020 3.7.2020 Veklury remdesivir Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1459 Concentrate for solution for infusion Powder for concentrate for solution for infusion Pending 3.7.2020 3.7.2020 Zimbus Breezhaler indacaterol/glycopyrronium/mometasone furoate Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1440 Inhalation powder, hard capsule R03AL12 6.7.2020 23.7.2020 Apixaban Accord apixaban Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/20/1458 Film-coated tablet B01AF02 27.7.2020 27.7.2020 Piqray alpelisib Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1455 Film-coated tablet L01XX65 28.7.2020 27.7.2020 Xenleta lefamulin Nabriva Therapeutics Ireland DAC Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland EU/1/20/1457 Film-coated tablet J01XX12 28.7.2020 27.7.2020 Zercepac trastuzumab Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/20/1456 Powder for concentrate for solution for infusion L01XC03 28.7.2020 31.7.2020 Hepcludex bulevirtide Myr GmbH Hessenring 89, 61348 Bad Homburg, Deutschland EU/1/20/1446 Powder for solution for injection J05AX28 5.8.2020 31.7.2020 Pretomanid FGK pretomanid FGK Representative Service GmbH Heimeranstraße 35, 80339 München, Deutschland EU/1/20/1437 Tablet Pending 4.8.2020 31.7.2020 Rozlytrek entrectinib Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/20/1460 Capsule, hard L01XE56 3.8.2020

— Issuing of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 6.7.2020 Hopveus D&A PHARMA 18 Rue Saint Matthieu, 78550 Houdan, France — 8.7.2020

— 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 3.7.2020 Brintellix H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/13/891 7.7.2020 3.7.2020 Capecitabine Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/12/762 6.7.2020 3.7.2020 Capecitabine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/761 6.7.2020 3.7.2020 Ecansya KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/12/763 6.7.2020 3.7.2020 Exforge Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/370 6.7.2020 3.7.2020 Harvoni Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/14/958 7.7.2020 3.7.2020 Hetlioz Vanda Pharmaceuticals Germany GmbH Französische Str. 12, c/o Satellite Office, 10117 Berlin, Deutschland EU/1/15/1008 6.7.2020 3.7.2020 Imatinib Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/808 6.7.2020 3.7.2020 Insulatard Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/233 6.7.2020 3.7.2020 Lemtrada Sanofi Belgium Leonardo Da Vincilaan 19, B-1831 Diegem, België EU/1/13/869 13.7.2020 3.7.2020 Lynparza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/959 7.7.2020 3.7.2020 Mixtard Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/231 6.7.2020 3.7.2020 Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/988 7.7.2020 3.7.2020 Pregabalin Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/15/1027 7.7.2020 3.7.2020 PREVYMIS Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/17/1245 7.7.2020 3.7.2020 Protaphane Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/234 6.7.2020 3.7.2020 Suboxone Indivior Europe Limited 27 Windsor Place, Dublin 2, Ireland EU/1/06/359 6.7.2020 3.7.2020 Teysuno Nordic Group B.V. Siriusdreef 41, 2132 WT Hoofddorp, Nederland EU/1/11/669 7.7.2020 3.7.2020 Xeloda Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/00/163 6.7.2020 6.7.2020 Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/12/802 7.7.2020 6.7.2020 Kolbam Retrophin Europe Limited Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/13/895 17.7.2020 6.7.2020 Picato LEO Laboratories Ltd 285 Cashel Road, Crumlin, Dublin 12, Ireland EU/1/12/796 8.7.2020 13.7.2020 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 15.7.2020 13.7.2020 BiResp Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/921 16.7.2020 13.7.2020 DuoResp Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/920 16.7.2020 13.7.2020 Kisqali Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1221 15.7.2020 13.7.2020 Lonquex Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/13/856 16.7.2020 13.7.2020 Mulpleo Shionogi B.V. Kingsfordweg 151, 1043 GR Amsterdam, Nederland EU/1/18/1348 17.7.2020 13.7.2020 Namuscla Lupin Europe GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland EU/1/18/1325 15.7.2020 13.7.2020 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/979 15.7.2020 13.7.2020 Tracleer Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/02/220 14.7.2020 16.7.2020 Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/12/802 22.7.2020 16.7.2020 Dukoral Valneva Sweden AB 105 21 Stockholm, Sverige EU/1/03/263 23.7.2020 16.7.2020 Toviaz Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/07/386 17.7.2020 17.7.2020 Capecitabine Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/12/762 23.7.2020 17.7.2020 Capecitabine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/761 21.7.2020 17.7.2020 Filgrastim Hexal Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland EU/1/08/496 23.7.2020 17.7.2020 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 22.7.2020 17.7.2020 Imlygic Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1064 27.7.2020 17.7.2020 Silodyx Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/607 27.7.2020 17.7.2020 Vihuma Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/16/1168 30.7.2020 23.7.2020 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 27.7.2020 23.7.2020 Bavencio Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1214 27.7.2020 23.7.2020 Besponsa Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1200 24.7.2020 23.7.2020 Ciambra Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Luxembourg EU/1/15/1055 27.7.2020 23.7.2020 Dectova GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/18/1349 28.7.2020 23.7.2020 Emtricitabine/Tenofovir disoproxil Krka KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/16/1151 30.7.2020 23.7.2020 Nordimet Nordic Group B.V. Siriusdreef 41, 2132 WT Hoofddorp, Nederland EU/1/16/1124 28.7.2020 23.7.2020 Omidria Omeros Ireland Limited Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, Ireland EU/1/15/1018 27.7.2020 23.7.2020 Translarna PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland EU/1/13/902 24.7.2020 23.7.2020 Vargatef Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/954 24.7.2020 23.7.2020 Votubia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/710 24.7.2020 23.7.2020 VPRIV Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/10/646 24.7.2020 24.7.2020 Remsima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/13/853 27.7.2020 27.7.2020 APTIVUS Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/05/315 28.7.2020 27.7.2020 Buccolam Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/709 29.7.2020 27.7.2020 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 5.8.2020 27.7.2020 Duzallo Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland EU/1/18/1300 28.7.2020 27.7.2020 Flucelvax Tetra Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands EU/1/18/1326 29.7.2020 27.7.2020 Fluenz Tetra AstraZeneca AB 151 85 Södertälje, Sverige EU/1/13/887 6.8.2020 27.7.2020 Iclusig Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/13/839 4.8.2020 27.7.2020 Imfinzi AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1322 29.7.2020 27.7.2020 Nerlynx Pierre Fabre Médicament 45, place Abel Gance, 92100 Boulogne-Billancourt, France EU/1/18/1311 28.7.2020 27.7.2020 Nuwiq Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/14/936 4.8.2020 27.7.2020 Orphacol Laboratoires CTRS 63 rue de l’Est, 92100 Boulogne-Billancourt, France EU/1/13/870 29.7.2020 27.7.2020 Praxbind Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/15/1056 28.7.2020 27.7.2020 Rilutek Sanofi Mature IP 54 rue La Boétie, 75008, Paris, France EU/1/96/010 28.7.2020 27.7.2020 Votrient Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/628 28.7.2020 31.7.2020 Cinryze Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/688 4.8.2020 31.7.2020 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 4.8.2020 31.7.2020 Evista SUBSTIPHARM 24 rue Erlanger, 75016 Paris, France EU/1/98/073 4.8.2020 31.7.2020 Exjade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/356 4.8.2020 31.7.2020 LIBTAYO Regeneron Ireland Designated Activity Company (DAC) Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland EU/1/19/1376 4.8.2020 31.7.2020 Olanzapine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/427 3.8.2020 31.7.2020 Qutenza Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland EU/1/09/524 4.8.2020 31.7.2020 Retacrit Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/07/431 4.8.2020 31.7.2020 Ruxience Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/20/1431 4.8.2020 31.7.2020 Xolair Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/05/319 4.8.2020

— 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 13.7.2020 Kolbam Retrophin Europe Limited Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/13/895 15.7.2020 16.7.2020 Zurampic Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland EU/1/15/1080 31.7.2020 31.7.2020 Duzallo Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland EU/1/18/1300 31.7.2020

— 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 20.7.2020 PREVEXXION RN Marek’s disease vaccine (live recombinant) Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/20/254 Concentrate and solvent for suspension for injection QI01AD03 23.7.2020 20.7.2020 PREVEXXION RN+HVT+IBD Infectious bursal disease and Marek’s disease vaccine (live recombinant) Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/20/255 Concentrate and solvent for suspension for injection QI01AD15 23.7.2020

— 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 1.7.2020 Leucofeligen FeLV/RCP VIRBAC 1ère avenue 2065 m LID, 06516 Carros, France EU/2/09/097 10.7.2020 1.7.2020 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/07/078 13.7.2020 1.7.2020 Zulvac 1 + 8 Bovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/139 2.7.2020 20.7.2020 FORTEKOR PLUS Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/15/185 23.7.2020 20.7.2020 Rabitec Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/17/219 23.7.2020 20.7.2020 Vectormune ND CEVA-Phylaxia Co. Ltd Szállás u. 5, 1107 Budapest, Magyarország EU/2/15/188 24.7.2020

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.