Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2021 to 31 July 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 346/02)

— 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 16.7.2021 Bylvay odevixibat Albireo AB Arvid Wallgrens Backe 20, 413 46 Gothenburg, Sverige EU/1/21/1566 Capsule, hard A05AX05 19.7.2021 16.7.2021 Icatibant Accord icatibant Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/21/1567 Solution for injection B06AC02 20.7.2021 16.7.2021 Imcivree setmelanotide Rhythm Pharmaceuticals Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland EU/1/21/1564 Solution for injection in a vial A08AA12 19.7.2021 16.7.2021 Klisyri tirbanibulin Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/21/1558 Ointment D06BX03 19.7.2021 16.7.2021 Ryeqo relugolix/estradiol/norethisterone acetate Gedeon Richter Plc. Gyömrői út 19-21, 1103 Budapest, Magyarország EU/1/21/1565 Film-coated tablet H01CC54 20.7.2021 16.7.2021 Skysona elivaldogene autotemcel bluebird bio (Netherlands) B.V. Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland EU/1/21/1563 Dispersion for infusion Pending 19.7.2021 16.7.2021 Verquvo vericiguat Bayer AG D-51368 Leverkusen, Deutschland EU/1/21/1561 Film-coated tablet C01DX22 20.7.2021

— 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 1.7.2021 alli GlaxoSmithKline Dungarvan Limited Knockbrack, Dungarvan, Co. Waterford, Ireland EU/1/07/401 12.7.2021 1.7.2021 Bexsero GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 12.7.2021 1.7.2021 Erivedge Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/848 5.7.2021 1.7.2021 Synagis AstraZeneca AB 151 85 Södertälje, Sverige EU/1/99/117 1.7.2021 1.7.2021 Vaxzevria AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 1.7.2021 5.7.2021 Busulfan Fresenius Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/14/951 8.7.2021 5.7.2021 Icandra Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/484 6.7.2021 5.7.2021 Ilumetri Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/18/1323 6.7.2021 5.7.2021 Lamzede Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/17/1258 7.7.2021 5.7.2021 Nilemdo Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/20/1425 16.7.2021 5.7.2021 Nuwiq Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/14/936 6.7.2021 5.7.2021 Rasilez HCT Noden Pharma DAC D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland EU/1/08/491 6.7.2021 5.7.2021 Trydonis Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/18/1274 6.7.2021 5.7.2021 Voriconazole Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/13/835 6.7.2021 5.7.2021 Zomarist Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/483 6.7.2021 9.7.2021 Anagrelide Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1256 16.7.2021 9.7.2021 Clopidogrel Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/08/465 12.7.2021 9.7.2021 COVID-19 Vaccine Janssen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1525 9.7.2021 9.7.2021 Imraldi Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/17/1216 14.7.2021 9.7.2021 Levetiracetam Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/13/889 13.7.2021 9.7.2021 ProQuad MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/05/323 12.7.2021 9.7.2021 Qutenza Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland EU/1/09/524 19.7.2021 9.7.2021 Steglatro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1267 12.7.2021 9.7.2021 Zynteglo bluebird bio (Netherlands) B.V. Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland EU/1/19/1367 18.7.2021 13.7.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 13.7.2021 13.7.2021 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30, 28010 Madrid, España EU/1/20/1507 13.7.2021 16.7.2021 Bevespi Aerosphere AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1339 19.7.2021 16.7.2021 Bridion Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/466 26.7.2021 16.7.2021 Brintellix H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/13/891 20.7.2021 16.7.2021 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 22.7.2021 16.7.2021 Emgality Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/18/1330 20.7.2021 16.7.2021 Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1148 24.7.2021 16.7.2021 Evicel Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, 1831 Diegem, België EU/1/08/473 2.8.2021 16.7.2021 IBRANCE Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/16/1147 20.7.2021 16.7.2021 Idefirix Hansa Biopharma AB P.O. Box 785, 220 07 Lund, Sverige EU/1/20/1471 21.7.2021 16.7.2021 Irbesartan Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/06/376 24.7.2021 16.7.2021 Onivyde pegylated liposomal Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/16/1130 19.7.2021 16.7.2021 Rapamune Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/01/171 20.7.2021 16.7.2021 Rekovelle Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark EU/1/16/1150 20.7.2021 16.7.2021 Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1127 24.7.2021 16.7.2021 Thalidomide Celgene Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/08/443 20.7.2021 16.7.2021 Vectibix Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/07/423 2.8.2021 16.7.2021 XALKORI Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/12/793 20.7.2021 16.7.2021 Zejula GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1235 19.7.2021 19.7.2021 Beovu Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/19/1417 20.7.2021 19.7.2021 Vaxzevria AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 19.7.2021 23.7.2021 Actos CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24, 17489 Greifswald, Deutschland EU/1/00/150 28.7.2021 23.7.2021 Afinitor Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/538 26.7.2021 23.7.2021 AUBAGIO Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/13/838 26.7.2021 23.7.2021 AYVAKYT Blueprint Medicines (Netherlands) B.V. Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland EU/1/20/1473 5.8.2021 23.7.2021 Beromun BELPHARMA s.a. 2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg EU/1/99/097 27.7.2021 23.7.2021 Bortezomib Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/15/1019 28.7.2021 23.7.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 23.7.2021 23.7.2021 COVID-19 Vaccine Janssen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1525 23.7.2021 23.7.2021 Edistride AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1052 26.7.2021 23.7.2021 Eylea Bayer AG D-51368 Leverkusen, Deutschland EU/1/12/797 27.7.2021 23.7.2021 Fluenz Tetra AstraZeneca AB 151 85 Södertälje, Sverige EU/1/13/887 26.7.2021 23.7.2021 Ibandronic Acid Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/642 26.7.2021 23.7.2021 Ilaris Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/564 26.7.2021 23.7.2021 Ivemend Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/437 26.7.2021 23.7.2021 Lamivudine Teva Pharma B.V. Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/596 26.7.2021 23.7.2021 Mekinist Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/931 26.7.2021 23.7.2021 Senshio Shionogi B.V. Kingsfordweg 151, 1043 GR Amsterdam, Nederland EU/1/14/978 27.7.2021 23.7.2021 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30, 28010 Madrid, España EU/1/20/1507 23.7.2021 28.7.2021 Deferiprone Lipomed Lipomed GmbH Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland EU/1/18/1310 29.7.2021 28.7.2021 Insulin lispro Sanofi Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1203 29.7.2021 28.7.2021 Jakavi Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/773 29.7.2021 28.7.2021 Lorviqua Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/19/1355 29.7.2021 28.7.2021 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 29.7.2021

— 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 19.7.2021 Glidipion Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/12/756 20.7.2021 23.7.2021 Lumoxiti AstraZeneca AB 151 85 Södertälje, Sverige EU/1/20/1522 1.8.2021

— 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 13.7.2021 Bonqat pregabalin Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/2/21/273 Oral solution QN03AX16 14.7.2021

— 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 13.7.2021 Clomicalm VIRBAC 1ère avenue 2065 m LID, 06516 Carros, France EU/2/98/007 16.7.2021 13.7.2021 Naxcel Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/05/053 15.7.2021 20.7.2021 Arti-Cell Forte Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/18/228 22.7.2021 26.7.2021 Arti-Cell Forte Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/18/228 27.7.2021 30.7.2021 Loxicom Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate, Monaghan, Ireland EU/2/08/090 3.8.2021

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.