Official Journal of the European Union

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.