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)
Date: 2021-04-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2021160EN.01000101.xml










30.4.2021   


EN


Official Journal of the European Union


C 160/1






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.