Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2021 to 31 March 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 160/01)

— 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 26.3.2021 Alymsys bevacizumab Mabxience Research SL C/ Manuel Pombo Angulo 28 — 3a y 4a Planta, 28050 Madrid, España EU/1/20/1509 Concentrate for solution for infusion L01XC07 30.3.2021 26.3.2021 BroPair Spiromax salmeterol / fluticasone propionate Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/21/1534 Inhalation powder R03AK06 30.3.2021 26.3.2021 Byfavo remimazolam PAION Netherlands B.V. Vogt 21, 6422 RK Heerlen, Nederland EU/1/20/1505 Powder for solution for injection N05CD14 29.3.2021 26.3.2021 Evrysdi risdiplam Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/21/1531 Powder for oral solution M09AX10 29.3.2021 26.3.2021 Kesimpta ofatumumab Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland EU/1/21/1532 Solution for injection Pending 29.3.2021 26.3.2021 NEXPOVIO selinexor Karyopharm Europe GmbH Franziska-Bilek-Weg 9, 80339 München, Deutschland EU/1/21/1537 Film-coated tablet L01XX66 29.3.2021 26.3.2021 Ontozry cenobamate Arvelle Therapeutics Netherlands B.V. Johannes Vermeerplein 9, 1071 DV Amsterdam, Nederland EU/1/21/1530 Film-coated tablet Tablet N03AX25 30.3.2021 26.3.2021 Oyavas bevacizumab STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/20/1510 Concentrate for solution for infusion L01XC07 30.3.2021 26.3.2021 Pemazyre pemigatinib Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/21/1535 Tablet L01EX20 29.3.2021 26.3.2021 Seffalair Spiromax salmeterol / fluticasone propionate Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/21/1533 Inhalation powder R03AK06 30.3.2021 26.3.2021 Thiotepa Riemser thiotepa RIEMSER Pharma GmbH An der Wiek 7, 17493 Greifswald-Insel Riems, Germany EU/1/21/1536 Powder for concentrate for solution for infusion L01AC01 29.3.2021 26.3.2021 Vazkepa icosapent ethyl Amarin Pharmaceuticals Ireland Limited 88 Harcourt Street, Dublin 2, D02DK18, Ireland EU/1/20/1524 Capsule, soft C10AX 29.3.2021 31.3.2021 Sogroya somapacitan Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/20/1501 Solution for injection in pre-filled pen H01AC07 6.4.2021

— 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 4.3.2021 Abraxane Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/07/428 5.3.2021 4.3.2021 Kymriah Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1297 5.3.2021 4.3.2021 Rubraca Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland EU/1/17/1250 8.3.2021 5.3.2021 Abraxane Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/07/428 8.3.2021 9.3.2021 Aclasta Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/05/308 10.3.2021 9.3.2021 Dificlir Tillotts Pharma GmbH Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland EU/1/11/733 12.3.2021 9.3.2021 Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1148 10.3.2021 9.3.2021 Fulphila Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1329 10.3.2021 9.3.2021 Hyrimoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1286 10.3.2021 9.3.2021 Kentera Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/03/270 12.3.2021 9.3.2021 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 12.3.2021 9.3.2021 Kinzalkomb Bayer AG D-51368 Leverkusen, Deutschland EU/1/02/214 11.3.2021 9.3.2021 Kivexa ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/04/298 10.3.2021 9.3.2021 Komboglyze AstraZeneca AB 151 85 Södertälje, Sverige EU/1/11/731 10.3.2021 9.3.2021 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 11.3.2021 9.3.2021 Lorviqua Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/19/1355 10.3.2021 9.3.2021 Onglyza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/09/545 10.3.2021 9.3.2021 PritorPlus Bayer AG D-51368 Leverkusen, Deutschland EU/1/02/215 11.3.2021 9.3.2021 Qtern AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1108 10.3.2021 9.3.2021 SonoVue Bracco International B.V. Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland EU/1/01/177 10.3.2021 9.3.2021 TAGRISSO AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1086 10.3.2021 9.3.2021 Telzir ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/04/282 10.3.2021 9.3.2021 Trizivir ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/00/156 10.3.2021 9.3.2021 Ziagen ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/99/112 10.3.2021 10.3.2021 Nexium Control GlaxoSmithKline Dungarvan Limited Dungarvan, Co. Waterford, Ireland EU/1/13/860 11.3.2021 10.3.2021 Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1089 11.3.2021 10.3.2021 Pravafenix LABORATOIRES SMB SA 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België EU/1/11/679 23.3.2021 10.3.2021 Pregabalin Zentiva k.s Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1166 13.3.2021 10.3.2021 Twinrix Adult GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/96/020 15.3.2021 10.3.2021 Twinrix Paediatric GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/97/029 15.3.2021 17.3.2021 Arixtra Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/02/206 19.3.2021 17.3.2021 Coagadex BPL Bioproducts Laboratory GmbH Dornhofstrasse 34, 63263 Neu-Isenburg, Deutschland EU/1/16/1087 19.3.2021 17.3.2021 Perjeta Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/813 18.3.2021 18.3.2021 Budesonide/Formoterol Teva Pharma B.V. Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/19/1403 22.3.2021 18.3.2021 Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/741 22.3.2021 18.3.2021 Synagis AstraZeneca AB 151 85 Södertälje, Sverige EU/1/99/117 22.3.2021 18.3.2021 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/04/274 19.3.2021 19.3.2021 COVID-19 Vaccine AstraZeneca AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 19.3.2021 22.3.2021 Advagraf Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/07/387 25.3.2021 22.3.2021 Ambirix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/02/224 23.3.2021 22.3.2021 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/12/792 24.3.2021 22.3.2021 Entyvio Takeda Pharma A/S Delta Park 45, 2665 Vallensbæk Strand, Danmark EU/1/14/923 24.3.2021 22.3.2021 Epclusa Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1116 23.3.2021 22.3.2021 Fulvestrant Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1253 23.3.2021 22.3.2021 Levitra Bayer AG D-51368 Leverkusen, Deutschland EU/1/03/248 23.3.2021 22.3.2021 Lysodren HRA Pharma Rare Diseases 200 avenue de Paris, 92320 Chatillon, France EU/1/04/273 24.3.2021 22.3.2021 MicardisPlus Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/02/213 23.3.2021 22.3.2021 M-M-RVAXPRO MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/337 24.3.2021 22.3.2021 Ozempic Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/17/1251 24.3.2021 22.3.2021 Respreeza CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/15/1006 6.4.2021 22.3.2021 Semglee Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1270 23.3.2021 22.3.2021 Simponi Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/09/546 29.3.2021 22.3.2021 Sivextro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/991 25.3.2021 22.3.2021 Vivanza Bayer AG D-51368 Leverkusen, Deutschland EU/1/03/249 23.3.2021 22.3.2021 Zubsolv Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/17/1233 23.3.2021 26.3.2021 BLINCYTO Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1047 30.3.2021 26.3.2021 CABOMETYX Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/16/1136 29.3.2021 26.3.2021 Epivir ViiV Healthcare B.V. Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands EU/1/96/015 29.3.2021 26.3.2021 IKERVIS Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi EU/1/15/990 31.3.2021 26.3.2021 Inbrija Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland EU/1/19/1390 29.3.2021 26.3.2021 Palynziq BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland EU/1/19/1362 30.3.2021 26.3.2021 Quofenix A. Menarini — Industrie Farmaceutiche Riunite — s.r.l. Via Sette Santi 3, 50131 Florence, Italia EU/1/19/1393 30.3.2021 26.3.2021 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/901 30.3.2021 26.3.2021 Tacforius Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/17/1244 30.3.2021 26.3.2021 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 30.3.2021 26.3.2021 Tysabri Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/06/346 30.3.2021 26.3.2021 Vfend Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/02/212 30.3.2021 26.3.2021 Zolgensma Novartis Gene Therapies EU Limited Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland EU/1/20/1443 31.3.2021 26.3.2021 Zometa Phoenix Labs Unlimited Company Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland EU/1/01/176 30.3.2021 31.3.2021 Doptelet Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/19/1373 6.4.2021 31.3.2021 Eliquis Bristol-Myers Squibb/Pfizer EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/11/691 6.4.2021 31.3.2021 Lorviqua Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/19/1355 6.4.2021 31.3.2021 PecFent Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/10/644 7.4.2021 31.3.2021 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 6.4.2021 31.3.2021 Verkazia Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi EU/1/17/1219 7.4.2021 31.3.2021 Zolgensma Novartis Gene Therapies EU Limited Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland EU/1/20/1443 6.4.2021

— 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 11.3.2021 Aftovaxpur Doe Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/13/153 15.3.2021 12.3.2021 Eurican Herpes 205 Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/01/029 24.3.2021 12.3.2021 Purevax RC Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/051 15.3.2021 12.3.2021 Purevax RCP Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/052 15.3.2021 12.3.2021 Purevax RCPCh Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/050 15.3.2021 12.3.2021 Purevax RCP FeLV Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/048 15.3.2021 18.3.2021 Contacera Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/144 24.3.2021 18.3.2021 FRONTPRO Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/19/240 24.3.2021 18.3.2021 Purevax FeLV Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/00/019 24.3.2021 18.3.2021 Purevax Rabies Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/10/117 24.3.2021 19.3.2021 Acticam Ecuphar NV Legeweg 157-i, 8020 Oostkamp, België EU/2/08/088 24.3.2021 26.3.2021 BROADLINE Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/13/157 29.3.2021 26.3.2021 Locatim Biokema Anstalt Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein EU/2/99/011 29.3.2021 26.3.2021 NexGard Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/13/159 29.3.2021 26.3.2021 NEXGARD SPECTRA Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/14/177 29.3.2021 26.3.2021 Oncept IL-2 Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/13/150 30.3.2021 26.3.2021 Veraflox Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/10/107 29.3.2021 29.3.2021 GALLIPRANT Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/17/221 31.3.2021 29.3.2021 Neocolipor Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/98/008 31.3.2021 29.3.2021 Previcox Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/045 30.3.2021 29.3.2021 SevoFlo Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/02/035 31.3.2021 31.3.2021 Advocate Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/03/039 7.4.2021 31.3.2021 Baycox Iron Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/19/239 8.4.2021 31.3.2021 ProteqFlu Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/03/037 9.4.2021 31.3.2021 ProteqFlu-Te Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/03/038 9.4.2021 31.3.2021 Vaxxitek HVT + IBD Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/02/032 9.4.2021

— 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 22.3.2021 Acticam Ecuphar NV Legeweg 157-i, 8020 Oostkamp, België EU/2/08/088 24.3.2021

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.