Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2021 to 30 September 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 441/01)

— 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 16.9.2021 Cometriq cabozantinib Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/13/890 Capsule, hard L01EX07 22.9.2021 22.9.2021 Imatinib Koanaa imatinib Koanaa Healthcare GmbH Fehrgasse 7, 2401 Fischamend, Österreich EU/1/21/1568 Oral solution L01EA01 24.9.2021

— 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 1.9.2021 Deferasirox Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/19/1386 2.9.2021 1.9.2021 Herceptin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/00/145 29.9.2021 1.9.2021 Repaglinide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/11/743 2.9.2021 1.9.2021 Ultomiris Alexion Europe SAS 103-105 Rue Anatole France, 92300 Levallois-Perret, France EU/1/19/1371 2.9.2021 1.9.2021 ZINPLAVA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/16/1156 3.9.2021 3.9.2021 COVID-19 Vaccine Janssen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1525 6.9.2021 6.9.2021 Riluzole Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/12/768 7.9.2021 6.9.2021 Ristfor Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/10/620 7.9.2021 14.9.2021 Vaxzevria AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 14.9.2021 15.9.2021 Amlodipine/Valsartan Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/16/1092 17.9.2021 15.9.2021 Cystadrops Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/15/1049 28.9.2021 15.9.2021 Emtricitabine/Tenofovir disoproxil Krka KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/16/1151 16.9.2021 15.9.2021 Exjade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/356 16.9.2021 15.9.2021 Fulphila Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/18/1329 23.9.2021 15.9.2021 Janumet Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/455 17.9.2021 15.9.2021 Resolor Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/09/581 16.9.2021 15.9.2021 TachoSil Corza Medical GmbH Speditionsstraße 21, 40221 Düsseldorf, Deutschland EU/1/04/277 16.9.2021 15.9.2021 Tadalafil Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/14/961 23.9.2021 16.9.2021 ADCETRIS Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/12/794 20.9.2021 16.9.2021 Darunavir Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1140 17.9.2021 16.9.2021 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München, Deutschland EU/1/13/875 17.9.2021 16.9.2021 Elebrato Ellipta GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1237 17.9.2021 16.9.2021 Epivir ViiV Healthcare B.V. Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands EU/1/96/015 20.9.2021 16.9.2021 Exviera AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/983 20.9.2021 16.9.2021 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/00/152 21.9.2021 16.9.2021 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 17.9.2021 16.9.2021 Lenalidomide Mylan Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1490 23.9.2021 16.9.2021 Movymia STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/16/1161 17.9.2021 16.9.2021 Parsabiv Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1142 20.9.2021 16.9.2021 Revlimid Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/07/391 21.9.2021 16.9.2021 Rubraca Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland EU/1/17/1250 20.9.2021 16.9.2021 SomaKit TOC Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France EU/1/16/1141 20.9.2021 16.9.2021 Terrosa Gedeon Richter Plc. Gyömrői út 19-21, 1103 Budapest, Magyarország EU/1/16/1159 29.9.2021 16.9.2021 Trelegy Ellipta GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1236 17.9.2021 16.9.2021 Vosevi Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/17/1223 20.9.2021 16.9.2021 Zynteglo bluebird bio (Netherlands) B.V. Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland EU/1/19/1367 17.9.2021 22.9.2021 AJOVY Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/19/1358 23.9.2021 22.9.2021 Anagrelide Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/17/1256 29.9.2021 22.9.2021 Azilect Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/04/304 23.9.2021 22.9.2021 BeneFIX Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/97/047 23.9.2021 22.9.2021 Constella Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland EU/1/12/801 4.10.2021 22.9.2021 Defitelio Gentium S.r.I. Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia EU/1/13/878 5.10.2021 22.9.2021 Docetaxel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/611 24.9.2021 22.9.2021 Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1133 27.9.2021 22.9.2021 Febuxostat Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/17/1194 27.9.2021 22.9.2021 Hepcludex Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1446 23.9.2021 22.9.2021 Insulatard Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/233 23.9.2021 22.9.2021 Intuniv Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/15/1040 23.9.2021 22.9.2021 Mepsevii Ultragenyx Germany GmbH Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland EU/1/18/1301 23.9.2021 22.9.2021 Mixtard Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/231 26.9.2021 22.9.2021 NovoRapid Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/99/119 23.9.2021 22.9.2021 Protaphane Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/234 23.9.2021 22.9.2021 Telmisartan Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/10/639 23.9.2021 22.9.2021 Triumeq ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/14/940 23.9.2021 22.9.2021 Viekirax AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/982 23.9.2021 22.9.2021 Vihuma Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/16/1168 28.9.2021 22.9.2021 Volibris GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/08/451 23.9.2021 22.9.2021 Xultophy Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/14/947 23.9.2021 22.9.2021 Zoledronic acid Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/12/759 23.9.2021 22.9.2021 Zoledronic acid Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/12/786 5.10.2021 23.9.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 23.9.2021 23.9.2021 Grastofil Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/13/877 27.9.2021 23.9.2021 Levemir Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/04/278 26.9.2021 23.9.2021 Liprolog Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/01/195 27.9.2021 23.9.2021 Rasagiline ratiopharm Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/977 24.9.2021 23.9.2021 Rezolsta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/967 24.9.2021 23.9.2021 Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1 + 3, 82041 Oberhaching, Deutschland EU/1/09/585 27.9.2021 23.9.2021 Zoledronic acid Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/13/834 27.9.2021 29.9.2021 Adakveo Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1476 30.9.2021 29.9.2021 Ambrisentan Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/19/1368 1.10.2021 29.9.2021 Atazanavir Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/16/1091 30.9.2021 29.9.2021 Brilique AstraZeneca AB 151 85 Södertälje, Sverige EU/1/10/655 1.10.2021 29.9.2021 Cinacalcet Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/15/1054 1.10.2021 29.9.2021 COVID-19 Vaccine Janssen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1525 29.9.2021 29.9.2021 Duloxetine Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1010 30.9.2021 29.9.2021 Duloxetine Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1028 30.9.2021 29.9.2021 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/17/1222 30.9.2021 29.9.2021 Entacapone Orion Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/11/708 1.10.2021 29.9.2021 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 1.10.2021 29.9.2021 Ivabradine Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1144 30.9.2021 29.9.2021 Lamivudine / Zidovudine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/663 1.10.2021 29.9.2021 Nevirapine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/598 1.10.2021 29.9.2021 NovoSeven Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/96/006 1.10.2021 29.9.2021 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/06/380 4.10.2021 29.9.2021 Ryzodeg Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/12/806 1.10.2021 29.9.2021 Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/09/603 4.10.2021 29.9.2021 Sildenafil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/584 1.10.2021 29.9.2021 Symtuza Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/17/1225 30.9.2021 29.9.2021 TAKHZYRO Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/18/1340 30.9.2021 29.9.2021 Tresiba Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/12/807 1.10.2021 29.9.2021 Vemlidy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1154 30.9.2021 29.9.2021 Zalviso FGK Representative Service GmbH Heimeranstraße 35, 80339 München, Deutschland EU/1/15/1042 4.10.2021 29.9.2021 Zydelig Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/14/938 30.9.2021

— 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 16.9.2021 Halagon Emdoka bvba J. Lijsenstraat 16, 2321 Hoogstraten, België EU/2/16/201 17.9.2021 16.9.2021 Nobivac L4 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/12/143 18.9.2021 16.9.2021 Respiporc Flu3 Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/09/103 17.9.2021 28.9.2021 Inflacam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/11/134 4.10.2021 28.9.2021 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/07/078 4.10.2021

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.