Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2021 to 28 February 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 105/01)

— 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 4.2.2021 Rukobia fostemsavir ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/20/1518 Prolonged-release tablet J05AX29 5.2.2021 5.2.2021 Kixelle Insulin aspart Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1506 Solution for injection A10AB05 8.2.2021 8.2.2021 Inrebic fedratinib Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/20/1514 Capsule, hard L01XE57 9.2.2021 8.2.2021 Lumoxiti moxetumomab pasudotox AstraZeneca AB 151 85 Södertälje, Sverige EU/1/20/1522 Powder for concentrate and solution for solution for infusion L01XC34 9.2.2021 11.2.2021 Lenalidomide Krka lenalidomide KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/20/1520 Capsule, hard L04AX04 15.2.2021 11.2.2021 Lenalidomide Krka d.d. lenalidomide KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/20/1521 Capsule, hard L04AX04 2.3.2021 11.2.2021 Lenalidomide Krka d.d. Novo mesto lenalidomide KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/20/1519 Capsule, hard L04AX04 12.2.2021 11.2.2021 Ogluo glucagon Xeris Pharmaceuticals Ireland Limited 8th Floor Block East, Iveagh Court, Harcourt Road, Dublin 2, Ireland EU/1/20/1523 Solution for injection in a pre-filled syringe Solution for injection in pre-filled pen H04AA01 17.2.2021 11.2.2021 Retsevmo selpercatinib Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/20/1527 Capsule, hard L01EX22 12.2.2021 11.2.2021 Sunitinib Accord sunitinib Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/20/1511 Capsule, hard L01XE04 12.2.2021 11.2.2021 TUKYSA tucatinib Seagen B.V. Evert van de Beekstraat 1-140, 1118CL Schiphol, Nederland EU/1/20/1526 Film-coated tablet L01EH03 12.2.2021 11.2.2021 Yuflyma adalimumab Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/20/1513 Solution for injection L04AB04 12.2.2021 18.2.2021 Heplisav B hepatitis B surface antigen Dynavax GmbH Eichsfelder Strasse 11, D-40595 Düsseldorf, Deutschland EU/1/20/1503 Solution for injection J07BC01 19.2.2021

— 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 1.2.2021 Rizmoic Shionogi B.V. Kingsfordweg 151, 1043 GR Amsterdam, Nederland EU/1/18/1291 11.2.2021 1.2.2021 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/05/330 4.2.2021 2.2.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 2.2.2021 4.2.2021 Clopidogrel ratiopharm Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/975 8.2.2021 4.2.2021 Gazyvaro Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/14/937 10.2.2021 4.2.2021 HALAVEN Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/11/678 5.2.2021 4.2.2021 IDELVION CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/16/1095 5.2.2021 4.2.2021 Juluca ViiV Healthcare B.V. Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands EU/1/18/1282 5.2.2021 4.2.2021 Kuvan BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/08/481 5.2.2021 4.2.2021 Mycamine Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/08/448 10.2.2021 4.2.2021 Reblozyl Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/20/1452 8.2.2021 4.2.2021 Spravato Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/19/1410 5.2.2021 4.2.2021 Sycrest Organon N.V. Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/10/640 23.2.2021 4.2.2021 TOOKAD Steba Biotech S.A 7 Place du Théâtre, 2613 Luxembourg, Luxembourg EU/1/17/1228 5.2.2021 4.2.2021 VEYVONDI Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/18/1298 5.2.2021 4.2.2021 Waylivra Akcea Therapeutics Ireland Limited Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland EU/1/19/1360 8.2.2021 4.2.2021 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/13/846 10.2.2021 8.2.2021 Clopidogrel BGR Laboratoires BIOGARAN 15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France EU/1/09/558 16.2.2021 8.2.2021 EndolucinBeta ITM Medical Isotopes GmbH Lichtenbergstraße 1, 85748 Garching, Deutschland EU/1/16/1105 9.2.2021 8.2.2021 Zavesca Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/02/238 9.2.2021 11.2.2021 ALPROLIX Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/16/1098 12.2.2021 11.2.2021 Bortezomib Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/16/1114 12.2.2021 11.2.2021 Bosulif Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/13/818 12.2.2021 11.2.2021 Clopidogrel Taw Pharma Taw Pharma (Ireland) Limited 104 Lower Baggot Street, Dublin 2, Ireland EU/1/09/568 26.2.2021 11.2.2021 Cometriq Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/13/890 9.3.2021 11.2.2021 Descovy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1099 17.2.2021 11.2.2021 Galafold Amicus Therapeutics Europe Limited Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland EU/1/15/1082 12.2.2021 11.2.2021 Neparvis Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/16/1103 12.2.2021 11.2.2021 Omnitrope Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/06/332 15.2.2021 11.2.2021 Xerava Tetraphase Pharmaceuticals Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland EU/1/18/1312 22.2.2021 11.2.2021 Zavicefta Pfizer Ireland Pharmaceuticals Operations Support Group, Ringaskiddy, County Cork, Ireland EU/1/16/1109 12.2.2021 12.2.2021 Amlodipine/Valsartan Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1092 23.2.2021 12.2.2021 Clopidogrel Taw Pharma Taw Pharma (Ireland) Limited 104 Lower Baggot Street, Dublin 2, Ireland EU/1/09/568 25.2.2021 12.2.2021 Copalia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/372 15.2.2021 12.2.2021 Dafiro Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/371 15.2.2021 12.2.2021 Exforge HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/569 15.2.2021 12.2.2021 Karvea Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/97/049 15.2.2021 12.2.2021 Karvezide Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/98/085 15.2.2021 12.2.2021 Palonosetron Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/16/1104 15.2.2021 17.2.2021 Opsumit Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/893 18.2.2021 18.2.2021 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 22.2.2021 18.2.2021 Bortezomib Fresenius Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/19/1397 22.2.2021 18.2.2021 Bortezomib SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/16/1102 22.2.2021 18.2.2021 CellCept Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/96/005 19.2.2021 18.2.2021 Emselex zr pharma& GmbH Hietzinger Hauptstrasse 37, 1130 Wien, Österreich EU/1/04/294 26.2.2021 18.2.2021 Ifirmacombi KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/673 22.2.2021 18.2.2021 Mabthera Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/98/067 19.2.2021 18.2.2021 Myclausen Passauer Pharma GmbH Eiderstedter Weg 3, 14129 Berlin, Deutschland EU/1/10/647 22.2.2021 18.2.2021 Nimenrix Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/12/767 19.2.2021 18.2.2021 NutropinAq Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/00/164 19.2.2021 18.2.2021 Ongentys Bial — Portela & Ca, SA À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal EU/1/15/1066 19.2.2021 18.2.2021 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/04/274 19.2.2021 19.2.2021 Aprovel Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/97/046 24.2.2021 19.2.2021 CoAprovel Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/98/086 24.2.2021 19.2.2021 Copalia HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/575 22.2.2021 19.2.2021 Dafiro HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/574 22.2.2021 19.2.2021 Entresto Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/1058 23.2.2021 19.2.2021 Envarsus Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/935 23.2.2021 19.2.2021 Exforge Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/370 22.2.2021 19.2.2021 Hefiya Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1287 22.2.2021 19.2.2021 Ifirmasta KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480 2.3.2021 19.2.2021 INOmax Linde Healthcare AB SE-181 81 Lidingö, Sverige EU/1/01/194 23.2.2021 19.2.2021 Irbesartan HCT Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/06/377 22.2.2021 19.2.2021 Irbesartan / Hydrochlorothiazide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/583 22.2.2021 19.2.2021 Irbesartan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/576 1.3.2021 19.2.2021 Irbesartan Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/06/376 22.2.2021 19.2.2021 Mycophenolate mofetil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/439 1.3.2021 19.2.2021 Myfenax Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/438 1.3.2021 19.2.2021 Neparvis Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/16/1103 22.2.2021 19.2.2021 Ondexxya Alexion Europe S.A.S. 103 Rue Anatole France, 92300 Levallois Perret, France EU/1/18/1345 24.2.2021 19.2.2021 Soliris Alexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-Perret, France EU/1/07/393 24.2.2021 19.2.2021 TAKHZYRO Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/18/1340 22.2.2021 19.2.2021 Tamiflu Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/02/222 22.2.2021 23.2.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 23.2.2021 25.2.2021 Buccolam Laboratorios Lesvi, S.L. Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España EU/1/11/709 26.2.2021 25.2.2021 Clopidogrel/Acetylsalicylic acid Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/19/1395 1.3.2021 26.2.2021 Pazenir ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/18/1317 1.3.2021 26.2.2021 Spravato Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/19/1410 1.3.2021 26.2.2021 Vaxchora Emergent Netherlands B.V. Strawinskylaan 411, 1077 XX Amsterdam, Nederland EU/1/20/1423 1.3.2021

— 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 4.2.2021 Udenyca ERA Consulting GmbH Lange Straße 70, 29664 Walsrode, Deutschland EU/1/18/1303 5.2.2021

— 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 17.2.2021 Solensia frunevetmab Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/20/269 Solution for injection Pending 18.2.2021

— 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 1.2.2021 Meloxoral Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/10/111 3.2.2021 9.2.2021 BTVPUR Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/10/113 18.2.2021 9.2.2021 Cerenia Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/06/062 11.2.2021 9.2.2021 Draxxin Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/03/041 11.2.2021 9.2.2021 Emdocam Emdoka bvba J. Lijsenstraat 16, 2321 Hoogstraten, België EU/2/11/128 11.2.2021 9.2.2021 LETIFEND Laboratorios LETI, S.L.unipersonal C/ Del Sol 5, Polígono Industrial Norte, Tres Cantos, 28760 Madrid, España EU/2/16/195 11.2.2021 9.2.2021 Nobivac Bb Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/02/034 12.2.2021 9.2.2021 Porcilis PCV M Hyo Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/14/175 19.2.2021 9.2.2021 Reconcile Pegasus Laboratories Ireland Limited 10 McCurtain Hill, Clonakilty, County Cork, P85 K230, Ireland EU/2/08/080 11.3.2021 12.2.2021 Evalon Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/16/194 17.2.2021 12.2.2021 Halagon Emdoka bvba J. Lijsenstraat 16, 2321 Hoogstraten, België EU/2/16/201 15.2.2021 26.2.2021 Enteroporc Coli AC Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/20/262 1.3.2021

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.