Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de março de 2021 a 31 de março de 2021

[Publicado nos termos do artigo 13.o ou do artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho (1)]

(2021/C 160/01)

— Concessão de uma autorização de introdução no mercado [Artigo 13.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Autorizado

Data da decisão Nome do medicamento DCI (Denominação Comum Internacional) Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Forma farmacêutica Código ATC (código anatómico-terapêutico-químico) Data de notificação 26.3.2021 Alymsys bevacizumab Mabxience Research SL C/ Manuel Pombo Angulo 28 — 3a y 4a Planta, 28050 Madrid, España EU/1/20/1509 Concentrado para solução para perfusão L01XC07 30.3.2021 26.3.2021 BroPair Spiromax salmeterol/propionato de fluticasona Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/21/1534 Pó para inalação R03AK06 30.3.2021 26.3.2021 Byfavo remimazolam PAION Netherlands B.V. Vogt 21, 6422 RK Heerlen, Nederland EU/1/20/1505 Pó para solução injectável N05CD14 29.3.2021 26.3.2021 Evrysdi Risdiplam Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/21/1531 Pó para solução oral 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 Solução injectável Pending 29.3.2021 26.3.2021 NEXPOVIO selinexor Karyopharm Europe GmbH Franziska-Bilek-Weg 9, 80339 München, Deutschland EU/1/21/1537 Comprimido revestido por película L01XX66 29.3.2021 26.3.2021 Ontozry cenobamato Arvelle Therapeutics Netherlands B.V. Johannes Vermeerplein 9, 1071 DV Amsterdam, Nederland EU/1/21/1530 Comprimido Comprimido revestido por película N03AX25 30.3.2021 26.3.2021 Oyavas bevacizumab STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/20/1510 Concentrado para solução para perfusão L01XC07 30.3.2021 26.3.2021 Pemazyre pemigatinib Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/21/1535 Comprimido L01EX20 29.3.2021 26.3.2021 Seffalair Spiromax salmeterol/propionato de fluticasona Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/21/1533 Pó para inalação R03AK06 30.3.2021 26.3.2021 Thiotepa Riemser Tiotepa RIEMSER Pharma GmbH An der Wiek 7, 17493 Greifswald-Insel Riems, Germany EU/1/21/1536 Pó para concentrado para solução para perfusão L01AC01 29.3.2021 26.3.2021 Vazkepa eicosapente de etilo Amarin Pharmaceuticals Ireland Limited 88 Harcourt Street, Dublin 2, D02DK18, Ireland EU/1/20/1524 Cápsula mole C10AX 29.3.2021 31.3.2021 Sogroya somapacitano Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/20/1501 Solução para injecção em caneta pré-cheia H01AC07 6.4.2021

— Alteração de uma autorização de introdução no mercado [Artigo 13.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Autorizado

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 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 Emtricitabina / 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 Adulto GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/96/020 15.3.2021 10.3.2021 Twinrix Pediátrico 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 Vallensbaek 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 Bagsvaerd, 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

— Alteração de uma autorização de introdução no mercado [Artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Autorizado

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 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

— Retirada de uma autorização de introdução no mercado [Artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 22.3.2021 Acticam Ecuphar NV Legeweg 157-i, 8020 Oostkamp, België EU/2/08/088 24.3.2021

Os interessados podem solicitar o acesso ao relatório público dos medicamentos em questão e das decisões correspondentes junto de:

European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam NETHERLANDS

(1) JO L 136 de 30.4.2004, p. 1.