Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2019 to 31 August 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 334/01)

— 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 1.7.2019 Dovato dolutegravir/lamivudine ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/19/1370 Film-coated tablet J05AR25 3.7.2019 1.7.2019 Xromi hydroxycarbamide Nova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland EU/1/19/1366 Oral solution L01XX05 3.7.2019 2.7.2019 Ultomiris Ravulizumab Alexion Europe SAS 103-105 Rue Anatole France, 92300 Levallois-Perret, France EU/1/19/1371 Concentrate for solution for infusion L04AA 5.7.2019 25.7.2019 Cufence trientine dihydrochloride Univar BV Schouwburgplein 30-34, 3012 CL Rotterdam, Nederland EU/1/19/1365 Capsule, hard A16AX12 29.7.2019 25.7.2019 LysaKare arginine/lysine Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France EU/1/19/1381 Solution for infusion V03AF11 29.7.2019 25.7.2019 Posaconazole Accord posaconazole Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, España EU/1/19/1379 Gastro-resistant tablet J02AC04 30.7.2019 25.7.2019 Posaconazole AHCL posaconazole Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/19/1380 Oral suspension J02AC04 29.7.2019 2.8.2019 Azacitidine Celgene azacitidine Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/19/1382 Powder for suspension for injection L01BC07 6.8.2019 23.8.2019 Giapreza angiotensin II acetate La Jolla Pharmaceutical II B.V. Herengracht 500, 1017 CB Amsterdam, Nederland EU/1/19/1384 Concentrate for solution for infusion C01CX09 27.8.2019 26.8.2019 Lacosamide UCB lacosamide UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/19/1383 Film-coated tablet Solution for infusion Syrup N03AX18 28.8.2019

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 11.7.2019 Cabazitaxel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland — 15.7.2019 8.8.2019 Doxolipad TLC Biopharmaceuticals B.V. J.H. Oortweg 19, 2333CH Leiden, Netherlands — 12.8.2019

— 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 1.7.2019 Benlysta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/11/700 3.7.2019 1.7.2019 Cetrotide Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/99/100 3.7.2019 1.7.2019 Comtan Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/081 3.7.2019 1.7.2019 Eliquis Bristol-Myers Squibb/Pfizer EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/11/691 3.7.2019 1.7.2019 Eviplera Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/11/737 3.7.2019 1.7.2019 Exviera AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/983 3.7.2019 1.7.2019 Fiasp Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/16/1160 3.7.2019 1.7.2019 Instanyl Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/09/531 3.7.2019 1.7.2019 Mimpara Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/04/292 3.7.2019 1.7.2019 Ravicti Immedica Pharma AB SE-113 29 Stockholm, Sverige EU/1/15/1062 3.7.2019 1.7.2019 Symtuza Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/17/1225 3.7.2019 1.7.2019 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 3.7.2019 4.7.2019 Dukoral Valneva Sweden AB 105 21 Stockholm, Sverige EU/1/03/263 8.7.2019 4.7.2019 IKERVIS Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi EU/1/15/990 8.7.2019 4.7.2019 Kaletra AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/01/172 8.7.2019 4.7.2019 Nerlynx Pierre Fabre Médicament 45, place Abel Gance, 92100 Boulogne-Billancourt, France EU/1/18/1311 9.7.2019 4.7.2019 Orphacol Laboratoires CTRS 63 rue de l’Est, 92100 Boulogne-Billancourt, France EU/1/13/870 8.7.2019 4.7.2019 Prolia Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/10/618 8.7.2019 4.7.2019 Verkazia Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi EU/1/17/1219 8.7.2019 4.7.2019 Zinforo Pfizer Ireland Pharmaceuticals Operations Support Group, Ringaskiddy, County Cork, Ireland EU/1/12/785 8.7.2019 8.7.2019 Emtricitabine/Tenofovir disoproxil Krka d.d. Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1182 10.7.2019 8.7.2019 Hefiya Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1287 10.7.2019 8.7.2019 Pazenir ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/18/1317 10.7.2019 8.7.2019 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 10.7.2019 8.7.2019 Tremfya Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/17/1234 10.7.2019 8.7.2019 Viekirax AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/982 10.7.2019 8.7.2019 Xultophy Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/14/947 10.7.2019 9.7.2019 Elocta Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/15/1046 11.7.2019 11.7.2019 Ammonaps Immedica Pharma AB SE-113 29 Stockholm, Sverige EU/1/99/120 15.7.2019 11.7.2019 Defitelio Gentium S.r.I. Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia EU/1/13/878 15.7.2019 11.7.2019 Gliolan medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/07/413 15.7.2019 11.7.2019 Halimatoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1288 15.7.2019 11.7.2019 Tasigna Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/422 15.7.2019 18.7.2019 Jentadueto Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/12/780 29.7.2019 18.7.2019 Myocet Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/00/141 22.7.2019 18.7.2019 Norvir AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/96/016 22.7.2019 18.7.2019 Xadago Zambon S.p.A. Via Lillo del Duca 10, 20091 Bresso (MI), Italia EU/1/14/984 22.7.2019 18.7.2019 Xyrem UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/05/312 22.7.2019 19.7.2019 Besponsa Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1200 23.7.2019 19.7.2019 Colobreathe Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/747 23.7.2019 19.7.2019 Edistride AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1052 23.7.2019 19.7.2019 Exjade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/356 23.7.2019 19.7.2019 HyQvia Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/13/840 23.7.2019 19.7.2019 Incruse Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/922 23.7.2019 19.7.2019 Lartruvo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1143 23.7.2019 19.7.2019 Truvada Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/04/305 23.7.2019 19.7.2019 Truxima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/16/1167 23.7.2019 25.7.2019 Abasaglar Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/944 29.7.2019 25.7.2019 Abraxane Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/07/428 29.7.2019 25.7.2019 Anoro Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/898 29.7.2019 25.7.2019 Blitzima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1205 29.7.2019 25.7.2019 Corbilta Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/13/859 29.7.2019 25.7.2019 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München, Deutschland EU/1/13/875 29.7.2019 25.7.2019 Edistride AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1052 29.7.2019 25.7.2019 Forxiga AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/795 29.7.2019 25.7.2019 Gardasil 9 MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/15/1007 29.7.2019 25.7.2019 Genvoya Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/15/1061 29.7.2019 25.7.2019 Hepsera Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/03/251 29.7.2019 25.7.2019 Herceptin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/00/145 29.7.2019 25.7.2019 KANJINTI Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/18/1281 29.7.2019 25.7.2019 Lixiana Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/15/993 29.7.2019 25.7.2019 Maviret AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/17/1213 29.7.2019 25.7.2019 NexoBrid MediWound Germany GmbH Eisenstraße 5, 65428 Ruesselsheim, Deutschland EU/1/12/803 29.7.2019 25.7.2019 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/979 29.7.2019 25.7.2019 Ontruzant Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/17/1241 29.7.2019 25.7.2019 Ritemvia Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1207 29.7.2019 25.7.2019 Rolufta Ellipta GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/17/1174 29.7.2019 25.7.2019 Roteas Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/16/1152 29.7.2019 25.7.2019 Telmisartan Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/719 29.7.2019 25.7.2019 Temozolomide SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/697 29.7.2019 25.7.2019 Translarna PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland EU/1/13/902 29.7.2019 25.7.2019 Uptravi Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/15/1083 29.7.2019 25.7.2019 Visudyne CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24, 17489 Greifswald, Deutschland EU/1/00/140 29.7.2019 25.7.2019 Vizamyl GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge EU/1/14/941 29.7.2019 25.7.2019 Xigduo AstraZeneca AB 151 85 Södertälje, Sverige EU/1/13/900 29.7.2019 25.7.2019 Zalmoxis MolMed S.p.A. Via Olgettina 58, 20132 Milano, Italia EU/1/16/1121 29.7.2019 25.7.2019 Zinforo Pfizer Ireland Pharmaceuticals Operations Support Group, Ringaskiddy, County Cork, Ireland EU/1/12/785 29.7.2019 25.7.2019 Zometa Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/176 29.7.2019 31.7.2019 Aclasta Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/05/308 2.8.2019 31.7.2019 Adenuric Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/447 5.8.2019 31.7.2019 Adjupanrix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/09/578 2.8.2019 31.7.2019 Duloxetine Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/972 2.8.2019 31.7.2019 Fiasp Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/16/1160 2.8.2019 31.7.2019 Flebogamma DIF Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa EU/1/07/404 2.8.2019 31.7.2019 Forxiga AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/795 2.8.2019 31.7.2019 Inovelon Eisai GmbH Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland EU/1/06/378 2.8.2019 31.7.2019 Invirase Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/96/026 2.8.2019 31.7.2019 Ketoconazole HRA Laboratoire HRA Pharma 200 avenue de Paris, 92320 Chatillon, France EU/1/14/965 2.8.2019 31.7.2019 Nucala GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/15/1043 2.8.2019 31.7.2019 Rezolsta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/967 2.8.2019 31.7.2019 Stalevo Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/03/260 2.8.2019 31.7.2019 Tadalafil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/14/961 2.8.2019 31.7.2019 Thalidomide Celgene Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/08/443 2.8.2019 31.7.2019 Trazimera Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/18/1295 2.8.2019 31.7.2019 Vargatef Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/954 2.8.2019 31.7.2019 Vimpat UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/08/470 2.8.2019 31.7.2019 Xydalba Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland EU/1/14/986 2.8.2019 1.8.2019 Cyramza Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/957 5.8.2019 1.8.2019 Dupixent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1229 5.8.2019 1.8.2019 Ebymect AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1051 5.8.2019 1.8.2019 Faslodex AstraZeneca AB 151 85 Södertälje, Sverige EU/1/03/269 5.8.2019 1.8.2019 Harvoni Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/14/958 6.8.2019 1.8.2019 Herzuma Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1257 6.8.2019 1.8.2019 Hirobriz Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/594 6.8.2019 1.8.2019 Laventair Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/899 6.8.2019 2.8.2019 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1222 6.8.2019 2.8.2019 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 6.8.2019 2.8.2019 JETREA Oxurion NV Gaston Geenslaan 1, 3001 Leuven, België EU/1/13/819 6.8.2019 2.8.2019 Praxbind Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/15/1056 7.8.2019 8.8.2019 InductOs Medtronic BioPharma B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland EU/1/02/226 12.8.2019 8.8.2019 Levodopa/Carbidopa/Entacapone Orion Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/11/706 12.8.2019 8.8.2019 Stivarga Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/858 12.8.2019 8.8.2019 Teysuno Nordic Group B.V. Siriusdreef 22, 2132 WT Hoofddorp, Nederland EU/1/11/669 12.8.2019 9.8.2019 Jivi Bayer AG D-51368 Leverkusen, Deutschland EU/1/18/1324 13.8.2019 9.8.2019 Travatan Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/199 13.8.2019 9.8.2019 Truberzi Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland EU/1/16/1126 13.8.2019 9.8.2019 Victoza Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/09/529 13.8.2019 14.8.2019 Oslif Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/586 19.8.2019 23.8.2019 Aimovig Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1293 27.8.2019 23.8.2019 Brimica Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/963 27.8.2019 23.8.2019 Cinacalcet Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1054 27.8.2019 23.8.2019 Cometriq Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/13/890 27.8.2019 23.8.2019 Duaklir Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/964 27.8.2019 23.8.2019 Elmiron bene-Arzneimittel GmbH Herterichstraße 1-3, 81479 München, Deutschland EU/1/17/1189 27.8.2019 23.8.2019 Empliciti Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/16/1088 27.8.2019 23.8.2019 Firdapse BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland EU/1/09/601 27.8.2019 23.8.2019 Flucelvax Tetra Seqirus Netherlands B.V. Paasheuvelweg 28, 1105BJ Amsterdam, Netherlands EU/1/18/1326 27.8.2019 23.8.2019 Fluenz Tetra AstraZeneca AB 151 85 Södertälje, Sverige EU/1/13/887 27.8.2019 23.8.2019 Nordimet Nordic Group B.V. Siriusdreef 22, 2132 WT Hoofddorp, Nederland EU/1/16/1124 27.8.2019 23.8.2019 Otezla Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/14/981 27.8.2019 23.8.2019 Ovitrelle Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/00/165 27.8.2019 23.8.2019 Renagel Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/99/123 27.8.2019 23.8.2019 Sevelamer carbonate Winthrop Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/14/952 27.8.2019 23.8.2019 Sovaldi Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/894 27.8.2019 23.8.2019 Spinraza Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/17/1188 27.8.2019 23.8.2019 Trulicity Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/956 27.8.2019 23.8.2019 Zerbaxa Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1032 27.8.2019 26.8.2019 Emadine Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/095 28.8.2019 26.8.2019 Imraldi Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/17/1216 28.8.2019 26.8.2019 Jylamvo Therakind (Europe) Limited 3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland EU/1/17/1172 28.8.2019 26.8.2019 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 28.8.2019 26.8.2019 Levitra Bayer AG D-51368 Leverkusen, Deutschland EU/1/03/248 28.8.2019 26.8.2019 Mycophenolate mofetil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/439 28.8.2019 26.8.2019 Nevanac Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/433 28.8.2019 26.8.2019 Onbrez Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/593 28.8.2019 26.8.2019 Prasugrel Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1273 28.8.2019 26.8.2019 PREVYMIS Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/17/1245 28.8.2019 26.8.2019 Renvela Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/09/521 28.8.2019 26.8.2019 Soliris Alexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-Perret, France EU/1/07/393 28.8.2019 26.8.2019 TAGRISSO AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1086 28.8.2019 26.8.2019 Tasmar Meda AB Pipers väg 2A, 170 09 Solna, Sverige EU/1/97/044 28.8.2019 26.8.2019 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 28.8.2019 26.8.2019 Vargatef Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/954 28.8.2019 26.8.2019 Vivanza Bayer AG D-51368 Leverkusen, Deutschland EU/1/03/249 28.8.2019 31.8.2019 Kisqali Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1221 2.8.2019

— 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 19.7.2019 EVICTO selamectin VIRBAC 1ère avenue – 2065m – LID, 06516 Carros, France EU/2/19/242 Spot-on solution QP54AA05 23.7.2019 29.7.2019 NASYM Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56 Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/19/241 Lyophilisate and solvent for suspension for injection or nasal spray QI02AD04 31.7.2019

— 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 1.7.2019 Osurnia Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/14/170 3.7.2019 4.7.2019 Bravecto Plus Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/18/224 9.7.2019 29.7.2019 Advocate Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/03/039 31.7.2019 9.8.2019 Vectormune ND CEVA-Phylaxia Co. Ltd Szállás u. 5, 1107 Budapest, Magyarország EU/2/15/188 13.8.2019 19.8.2019 NexGard Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/13/159 21.8.2019 19.8.2019 NEXGARD SPECTRA Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/14/177 21.8.2019 29.8.2019 Bovilis Blue-8 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/17/218 2.9.2019

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 Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands

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