Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2021 to 31 August 2021

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

(2021/C 394/01)

— 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 18.8.2021 Abecma idecabtagene vicleucel Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/21/1539 Dispersion for infusion L01 19.8.2021 18.8.2021 Byooviz ranibizumab Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/21/1572 Solution for injection S01LA04 1.9.2021 18.8.2021 Evrenzo roxadustat Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/21/1574 Film-coated tablet B03XA05 19.8.2021 18.8.2021 Fingolimod Mylan fingolimod Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/21/1573 Capsule, hard L04AA27 1.9.2021 20.8.2021 Abiraterone Mylan abiraterone acetate Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/21/1571 Film-coated tablet L02BX03 1.9.2021 20.8.2021 Bimzelx bimekizumab UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/21/1575 Solution for injection L04AC21 23.8.2021 26.8.2021 Minjuvi tafasitamab Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/21/1570 Powder for concentrate for solution for infusion L01FX12 1.9.2021 26.8.2021 Voxzogo vosoritide BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland EU/1/21/1577 Powder and solvent for solution for injection M05BX07 1.9.2021

— 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 2.8.2021 CANCIDAS Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/01/196 31.8.2021 2.8.2021 Emadine Immedica Pharma AB SE-113 29 Stockholm, Sverige EU/1/98/095 5.8.2021 2.8.2021 Hepcludex MYR GmbH Hessenring 89, 61348 Bad Homburg, Deutschland EU/1/20/1446 9.8.2021 2.8.2021 Tolura KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/10/632 16.8.2021 5.8.2021 Forxiga AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/795 6.8.2021 12.8.2021 AMGEVITA Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1164 13.8.2021 12.8.2021 Azacitidine Mylan Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1426 13.8.2021 12.8.2021 Combivir ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/98/058 13.8.2021 12.8.2021 Cometriq Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/13/890 13.8.2021 12.8.2021 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 13.8.2021 12.8.2021 Pegasys zr pharma& GmbH Hietzinger Hauptstrasse 37, 1130 Wien, Österreich EU/1/02/221 30.8.2021 12.8.2021 Taltz Eli Lilly and Company (Ireland) Limited Dunderrow, Kinsale, Co. Cork, Ireland EU/1/15/1085 30.8.2021 18.8.2021 Fiasp Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/16/1160 19.8.2021 18.8.2021 Givlaari Alnylam Netherlands B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland EU/1/20/1428 19.8.2021 18.8.2021 Noxafil Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/05/320 1.9.2021 18.8.2021 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/979 19.8.2021 18.8.2021 Ogivri Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/18/1341 31.8.2021 18.8.2021 Rybelsus Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/20/1430 19.8.2021 18.8.2021 Rydapt Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1218 19.8.2021 18.8.2021 Suboxone Indivior Europe Limited 27 Windsor Place, Dublin 2, D02 DK44, Ireland EU/1/06/359 19.8.2021 18.8.2021 TAVLESSE Instituto Grifols, S.A. Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa EU/1/19/1405 31.8.2021 18.8.2021 Truxima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/16/1167 19.8.2021 18.8.2021 VITRAKVI Bayer AG D-51368 Leverkusen, Deutschland EU/1/19/1385 20.8.2021 18.8.2021 Voriconazole Hikma Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal EU/1/15/1004 23.8.2021 18.8.2021 Xeljanz Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/17/1178 19.8.2021 18.8.2021 Zostavax MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/341 19.8.2021 20.8.2021 AFSTYLA CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/16/1158 24.8.2021 20.8.2021 Apidra Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/04/285 23.8.2021 20.8.2021 Blitzima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1205 23.8.2021 20.8.2021 Caelyx pegylated liposomal Baxter Holding B.V. Kobaltweg 49, 3542 CE Utrecht, Nederland EU/1/96/011 23.8.2021 20.8.2021 Copiktra Secura Bio Limited 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland EU/1/21/1542 23.8.2021 20.8.2021 Dovato ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/19/1370 23.8.2021 20.8.2021 Evra Gedeon Richter Plc. Gyömrői út 19-21, 1103 Budapest, Magyarország EU/1/02/223 23.8.2021 20.8.2021 Imatinib Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/13/825 23.8.2021 20.8.2021 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 23.8.2021 20.8.2021 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/97/030 23.8.2021 20.8.2021 Kivexa ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/04/298 23.8.2021 20.8.2021 Rinvoq AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/19/1404 23.8.2021 20.8.2021 Rixathon Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1185 23.8.2021 20.8.2021 Ruxience Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/20/1431 23.8.2021 20.8.2021 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 24.8.2021 20.8.2021 Trizivir ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/00/156 23.8.2021 20.8.2021 Veklury Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1459 26.8.2021 26.8.2021 Adakveo Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1476 27.8.2021 26.8.2021 Combivir ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/98/058 27.8.2021 26.8.2021 Efficib Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/457 27.8.2021 26.8.2021 Inhixa Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland EU/1/16/1132 27.8.2021 26.8.2021 Mabthera Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/98/067 27.8.2021 26.8.2021 Mekinist Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/931 27.8.2021 26.8.2021 Riximyo Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1184 30.8.2021 26.8.2021 SonoVue Bracco International B.V. Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland EU/1/01/177 30.8.2021 26.8.2021 Stivarga Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/858 2.9.2021 26.8.2021 Tafinlar Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/865 27.8.2021 26.8.2021 Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1129 27.8.2021 26.8.2021 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 27.8.2021 27.8.2021 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 30.8.2021 27.8.2021 Ristaben Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/10/621 7.9.2021

— 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 16.8.2021 FATROVAX RHD Rabbit haemorrhagic disease vaccine (inactivated, recombinant) FATRO S.p.A. Via Emilia 285, 40064 Ozzano dell’Emilia (BO), ITALIA EU/2/21/275 Suspension for injection QI08AA01 17.8.2021 16.8.2021 Strangvac Streptococcus equi vaccine (recombinant proteins) Intervacc AB Vastertorpsvagen 135, 129 44 Hagersten, Sverige EU/2/21/274 Suspension for injection Pending 17.8.2021 16.8.2021 Tessie tasipimidine Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/2/21/276 Oral solution QN05CM96 17.8.2021

— 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 16.8.2021 ERAVAC Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/16/199 25.8.2021 18.8.2021 NASYM Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/19/241 1.9.2021 18.8.2021 Sedadex Le Vet Beheer B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/16/198 1.9.2021 30.8.2021 ECOPORC SHIGA Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/13/149 31.8.2021

— Withdrawal of a marketing authorisation (Article 38 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 16.8.2021 Porcilis Pesti Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/99/016 19.8.2021

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.