Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2019 to 31 March 2019

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )

(2019/C 153/01)

— 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 25.3.2019 Atazanavir Krka atazanavir Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/19/1353 Capsule, hard J05AE08 27.3.2019 28.3.2019 AJOVY fremanezumab Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/19/1358 Solution for injection Pending 1.4.2019 28.3.2019 Febuxostat Krka febuxostat Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/18/1347 Film-coated tablet M04AA03 1.4.2019

— 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 1.3.2019 Docetaxel Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/12/769 5.3.2019 1.3.2019 Herzuma Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1257 5.3.2019 1.3.2019 Lacosamide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/17/1230 5.3.2019 1.3.2019 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 5.3.2019 1.3.2019 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 5.3.2019 1.3.2019 Palonosetron Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/16/1104 5.3.2019 1.3.2019 Tegsedi Akcea Therapeutics Ireland Ltd Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland EU/1/18/1296 5.3.2019 5.3.2019 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 7.3.2019 5.3.2019 DaTSCAN GE Healthcare B.V. De Rondom 8, 5612 AP, Eindhoven, The Netherlands EU/1/00/135 7.3.2019 5.3.2019 Granpidam Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/16/1137 7.3.2019 5.3.2019 Instanyl Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/09/531 7.3.2019 5.3.2019 Kiovig Baxter AG Industriestraße 67, 1221 Wien, Österreich EU/1/05/329 7.3.2019 5.3.2019 Levetiracetam Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/11/713 7.3.2019 5.3.2019 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 7.3.2019 5.3.2019 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 7.3.2019 11.3.2019 Actrapid Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/230 13.3.2019 11.3.2019 Cresemba Basilea Pharmaceutica Deutschland GmbH Marie-Curie-Strasse 8, 79539 Loerrach, Baden-Wuerttemberg, Deutschland EU/1/15/1036 13.3.2019 11.3.2019 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1263 13.3.2019 11.3.2019 Ferriprox Apotex Europe B.V. Archimedesweg 2, 2333 CN Leiden, Nederland EU/1/99/108 13.3.2019 11.3.2019 Hemlibra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/18/1271 13.3.2019 11.3.2019 Herceptin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/00/145 13.3.2019 11.3.2019 INOmax Linde Healthcare AB SE-181 81 Lidingö, Sverige EU/1/01/194 13.3.2019 11.3.2019 Intrarosa Endoceutics S.A. Rue Belliard 40, 1040 Brussels, Belgium EU/1/17/1255 15.3.2019 11.3.2019 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 13.3.2019 11.3.2019 Luminity Lantheus EU Limited Atlantic Avenue, Westpark Business Campus, Shannon, Co. Clare, Ireland EU/1/06/361 13.3.2019 11.3.2019 Mabthera Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/98/067 13.3.2019 11.3.2019 Maviret AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/17/1213 13.3.2019 11.3.2019 Pelgraz Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/18/1313 15.3.2019 11.3.2019 Praluent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/15/1031 13.3.2019 11.3.2019 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 13.3.2019 11.3.2019 Qarziba EUSA Pharma (Netherlands) B.V. Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland EU/1/17/1191 13.3.2019 11.3.2019 Senshio Shionogi B.V. Kingsfordweg 151, 1043GR Amsterdam, Nederland EU/1/14/978 13.3.2019 11.3.2019 Slenyto RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux, 75002 Paris, France EU/1/18/1318 13.3.2019 11.3.2019 Stayveer Janssen Pharmaceutica N.V. Turnhoutseweg 30, 2340 Beerse, België EU/1/13/832 13.3.2019 11.3.2019 Varuby TESARO Bio Netherlands B.V. Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht, Nederland EU/1/17/1180 13.3.2019 11.3.2019 Zoledronic acid Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/13/834 15.3.2019 11.3.2019 Zykadia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/999 13.3.2019 13.3.2019 NovoMix Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/00/142 15.3.2019 13.3.2019 Ongentys Bial — Portela & Ca, SA À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal EU/1/15/1066 15.3.2019 13.3.2019 Reyataz Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/03/267 15.3.2019 13.3.2019 Rubraca Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland EU/1/17/1250 15.3.2019 20.3.2019 Edistride AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1052 22.3.2019 20.3.2019 Forxiga AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/795 22.3.2019 20.3.2019 SCENESSE Clinuvel Europe Limited 10 Earlsfort Terrace, Dublin 2, Ireland EU/1/14/969 22.3.2019 25.3.2019 ADYNOVI Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/17/1247 27.3.2019 25.3.2019 Baraclude Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/06/343 27.3.2019 25.3.2019 Clopidogrel Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/09/559 27.3.2019 25.3.2019 Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Slunná 16, 61700 Brno, Česká republika EU/1/09/541 27.3.2019 25.3.2019 Daklinza Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/14/939 27.3.2019 25.3.2019 Edarbi Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/11/734 27.3.2019 25.3.2019 Levemir Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/04/278 27.3.2019 25.3.2019 Lutathera Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France EU/1/17/1226 27.3.2019 25.3.2019 Nordimet Nordic Group B.V. Siriusdreef 22, 2132 WT Hoofddorp, Nederland EU/1/16/1124 27.3.2019 25.3.2019 Omidria Omeros Ireland Limited Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, Ireland EU/1/15/1018 27.3.2019 25.3.2019 Plegridy Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/14/934 27.3.2019 25.3.2019 Rotarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/05/330 27.3.2019 25.3.2019 Spinraza Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/17/1188 27.3.2019 25.3.2019 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 27.3.2019 25.3.2019 Zyllt Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/553 27.3.2019 28.3.2019 AMGEVITA Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1164 1.4.2019 28.3.2019 Bexsero GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 1.4.2019 28.3.2019 Clopidogrel Krka Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/556 1.4.2019 28.3.2019 Coagadex BPL Bioproducts Laboratory GmbH Dornhofstrasse 34, 63263 Neu-Isenburg, Deutschland EU/1/16/1087 29.3.2019 28.3.2019 Cometriq Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/13/890 1.4.2019 28.3.2019 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/17/1210 1.4.2019 28.3.2019 EndolucinBeta ITG Isotope Technologies Garching GmbH Lichtenbergstraße 1, 85748 Garching, Deutschland EU/1/16/1105 1.4.2019 28.3.2019 EVOTAZ Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1025 1.4.2019 28.3.2019 Galafold Amicus Therapeutics Europe Limited Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland EU/1/15/1082 1.4.2019 28.3.2019 Genvoya Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/15/1061 1.4.2019 28.3.2019 Glivec Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/198 1.4.2019 28.3.2019 Imatinib Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/808 1.4.2019 28.3.2019 Insulatard Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/233 1.4.2019 28.3.2019 Jylamvo Therakind (Europe) Limited 3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland EU/1/17/1172 1.4.2019 28.3.2019 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 1.4.2019 28.3.2019 Lamivudine/Zidovudine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/663 1.4.2019 28.3.2019 Mixtard Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/231 1.4.2019 28.3.2019 Nerlynx Puma Biotechnology B.V. Beechavenue 54, 1119 PW Schiphol-Rijk, Nederland EU/1/18/1311 29.3.2019 28.3.2019 NovoRapid Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/99/119 1.4.2019 28.3.2019 Opdivo Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/15/1014 1.4.2019 28.3.2019 Perjeta Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/813 1.4.2019 28.3.2019 Qutenza Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland EU/1/09/524 1.4.2019 28.3.2019 Segluromet Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1265 1.4.2019 28.3.2019 Sialanar Proveca Pharma Limited Marine House, Clanwilliam Place, Dublin 2, Ireland EU/1/16/1135 1.4.2019 28.3.2019 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363 1.4.2019 28.3.2019 Strensiq Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France EU/1/15/1015 1.4.2019 28.3.2019 Sustiva Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/99/110 1.4.2019 28.3.2019 VPRIV Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland EU/1/10/646 1.4.2019 28.3.2019 Xeloda Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/00/163 1.4.2019 29.3.2019 Jylamvo Therakind (Europe) Limited 3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland EU/1/17/1172 2.4.2019

— 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 29.3.2019 Arti-Cell Forte Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells Global Stem cell Technology (G.S.T.) NV Noorwegenstraat 4, 9940 Evergem, België EU/2/18/228 Suspension for injection Pending 2.4.2019

— 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 1.3.2019 Melosus CP-Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf, Deutschland EU/2/10/116 5.3.2019 1.3.2019 Prevomax Le Vet Beheer B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/17/211 5.3.2019 12.3.2019 Aivlosin ECO Animal Health Europe Limited 6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland EU/2/04/044 14.3.2019 12.3.2019 Reconcile Pegasus Laboratories Ireland Limited 10 McCurtain Hill, Clonakilty, County Cork, Ireland EU/2/08/080 14.3.2019 12.3.2019 Suprelorin VIRBAC S.A. 1ère Avenue - 2065 m — L.I.D., 06516 Carros Cedex, France EU/2/07/072 14.3.2019 14.3.2019 Fungitraxx Avimedical B.V. Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland EU/2/13/160 19.3.2019 14.3.2019 Loxicom Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate, Monaghan, Ireland EU/2/08/090 19.3.2019 27.3.2019 Activyl Tick Plus Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/11/137 29.3.2019 27.3.2019 Versican Plus DHPPi Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/169 29.3.2019 27.3.2019 Versican Plus Pi Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/168 29.3.2019

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 30 Churchill Place Canary Wharf London E14 5EU UNITED KINGDOM

(1) OJ L 136, 30.4.2004, p. 1.