Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2021 to 31 May 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-06-25
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_2021249EN.01000101.xml










25.6.2021   


EN


Official Journal of the European Union


C 249/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2021 to 31 May 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 249/01)
—   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




19.5.2021


Copiktra


duvelisib







Verastem Europe GmbH




Lange Strasse 70, Walsrode, Lower Saxony, 29664, Deutschland






EU/1/21/1542


Capsule, hard


L01EM04


21.5.2021




19.5.2021


Drovelis


drospirenone / estetrol







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/21/1547


Film-coated tablet


G03AA18


20.5.2021




19.5.2021


Lydisilka


drospirenone / estetrol







Estetra SRL




Rue Saint Georges 5-7, 4000 Liège, Belgique






EU/1/21/1548


Film-coated tablet


G03AA18


20.5.2021




19.5.2021


Ponvory


ponesimod







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1550


Film-coated tablet


L04AA


21.5.2021




27.5.2021


Efmody


hydrocortisone







Diurnal Europe B.V.




Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland






EU/1/21/1549


Modified-release capsule, hard


H02AB09


28.5.2021




—   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




6.5.2021


Daxas







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/10/636


10.5.2021




6.5.2021


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/17/1210


13.5.2021




6.5.2021


Zepatier







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/16/1119


9.5.2021




7.5.2021


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


7.5.2021




10.5.2021


Aerius







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/160


11.5.2021




10.5.2021


Alimta







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/04/290


12.5.2021




10.5.2021


Aprovel







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/97/046


11.5.2021




10.5.2021


Azacitidine Celgene







Celgene Europe B.V.




Winthontlaan 6 N, 3526 KV Utrecht, Nederland






EU/1/19/1382


17.5.2021




10.5.2021


Azomyr







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/157


11.5.2021




10.5.2021


Clopidogrel Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/09/559


11.5.2021




10.5.2021


Clopidogrel TAD







TAD Pharma GmbH




Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland






EU/1/09/555


17.5.2021




10.5.2021


CoAprovel







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/086


11.5.2021




10.5.2021


DUAVIVE







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/14/960


11.5.2021




10.5.2021


Imatinib Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/12/808


11.5.2021




10.5.2021


Karvea







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/97/049


11.5.2021




10.5.2021


Karvezide







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/085


11.5.2021




10.5.2021


LIBTAYO







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27 Ireland






EU/1/19/1376


11.5.2021




10.5.2021


Nodetrip







Esteve Pharmaceuticals S.A.




Passeig de la Zona Franca, 109, 08038 Barcelona, España






EU/1/04/297


12.5.2021




10.5.2021


Tybost







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/872


11.5.2021




10.5.2021


Tygacil







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/06/336


11.5.2021




10.5.2021


Zebinix







Bial — Portela & Ca, SA




À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal






EU/1/09/514


11.5.2021




10.5.2021


Zoely







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/11/690


20.5.2021




12.5.2021


Brineura







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, Ireland






EU/1/17/1192


18.5.2021




12.5.2021


Signifor







Recordati Rare Diseases




Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800 Puteaux, France






EU/1/12/753


17.5.2021




18.5.2021


Zolgensma







Novartis Gene Therapies EU Limited




Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland






EU/1/20/1443


19.5.2021




19.5.2021


Alkindi







Diurnal Europe B.V.




Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland






EU/1/17/1260


20.5.2021




19.5.2021


Amsparity







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/19/1415


21.5.2021




19.5.2021


Buvidal







Camurus AB




Ideon Science Park, 223 70 Lund, Sverige






EU/1/18/1336


20.5.2021




19.5.2021


Clopidogrel Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/556


24.5.2021




19.5.2021


Clopidogrel Krka d.d.







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/562


2.6.2021




19.5.2021


Diacomit







Biocodex




7 avenue Gallieni, 94250 Gentilly, France






EU/1/06/367


21.5.2021




19.5.2021


Entresto







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/15/1058


24.5.2021




19.5.2021


IBRANCE







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/16/1147


21.5.2021




19.5.2021


Lumeblue







Alfasigma S.p.A.




Via Ragazzi del '99, n.5, 40133 Bologna, Italia






EU/1/20/1470


21.5.2021




19.5.2021


Neparvis







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/16/1103


20.5.2021




19.5.2021


Qtern







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1108


21.5.2021




19.5.2021


Stribild







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/830


20.5.2021




19.5.2021


Telmisartan Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/610


21.5.2021




19.5.2021


Tysabri







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/06/346


21.5.2021




19.5.2021


Venclyxto







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/16/1138


27.5.2021




19.5.2021


Yuflyma







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/20/1513


21.5.2021




19.5.2021


Zyllt







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/553


24.5.2021




21.5.2021


BiResp Spiromax







Teva Pharma B.V.




Swensweg 5, 2031GA Haarlem, Nederland






EU/1/14/921


7.6.2021




21.5.2021


DuoResp Spiromax







Teva Pharma B.V.




Swensweg 5, 2031GA Haarlem, Nederland






EU/1/14/920


2.6.2021




21.5.2021


Evra







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/02/223


26.5.2021




21.5.2021


Glivec







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/01/198


26.5.2021




21.5.2021


Iscover







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/070


26.5.2021




21.5.2021


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


27.5.2021




21.5.2021


Lumeblue







Alfasigma S.p.A.




Via Ragazzi del '99, n.5, 40133 Bologna, Italia






EU/1/20/1470


25.5.2021




21.5.2021


Piqray







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/20/1455


26.5.2021




21.5.2021


Plavix







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/069


26.5.2021




21.5.2021


Quinsair







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/14/973


26.5.2021




21.5.2021


Rinvoq







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


26.5.2021




21.5.2021


Skyrizi







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1361


26.5.2021




21.5.2021


TAGRISSO







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1086


26.5.2021




21.5.2021


Talzenna







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/19/1377


26.5.2021




21.5.2021


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


25.5.2021




21.5.2021


Xelevia







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/382


27.5.2021




27.5.2021


Actelsar HCT







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/13/817


31.5.2021




27.5.2021


Akynzeo







Helsinn Birex Pharmaceuticals Ltd




Damastown, Mulhuddart, Dublin 15, Ireland






EU/1/15/1001


8.6.2021




27.5.2021


Giapreza







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/19/1384


1.6.2021




27.5.2021


Inhixa







Techdow Pharma Netherlands B.V.




Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland






EU/1/16/1132


8.6.2021




27.5.2021


Riximyo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1184


28.5.2021




27.5.2021


TESAVEL







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/435


31.5.2021




27.5.2021


Trajenta







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/11/707


7.6.2021




27.5.2021


Xeloda







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/00/163


31.5.2021




31.5.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


31.5.2021




—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected










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




3.5.2021


Elebrato Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1237


6.5.2021




3.5.2021


Temybric Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/19/1378


6.5.2021




3.5.2021


Trelegy Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1236


6.5.2021




—   Withdrawal of a marketing authorisation (Article 13 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




12.5.2021


Nodetrip







Esteve Pharmaceuticals S.A.




Passeig de la Zona Franca, 109, 08038 Barcelona, España






EU/1/04/297


17.5.2021




19.5.2021


Azacitidine Celgene







Celgene Europe B.V.




Winthontlaan 6 N, 3526 KV Utrecht, Nederland






EU/1/19/1382


21.5.2021




21.5.2021


Telmisartan Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/610


27.5.2021




—   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




4.5.2021


Metacam







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/97/004


5.5.2021




20.5.2021


Novem







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/042


25.5.2021




26.5.2021


Dexdomitor







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/02/033


31.5.2021




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.