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)
Date: 2021-09-29
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_2021394EN.01000101.xml










29.9.2021   


EN


Official Journal of the European Union


C 394/1






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.