Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2021 to 30 April 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 204/01)

— 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 21.4.2021 Abevmy bevacizumab Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1515 Concentrate for solution for infusion L01XC07 22.4.2021 21.4.2021 JEMPERLI dostarlimab GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/21/1538 Concentrate for solution for infusion L01XC40 22.4.2021 21.4.2021 Lextemy bevacizumab Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1516 Concentrate for solution for infusion L01XC07 22.4.2021 26.4.2021 Abiraterone Accord abiraterone acetate Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/20/1512 Film-coated tablet Tablet L02BX03 30.4.2021 30.4.2021 Orladeyo berotralstat Biocryst Ireland Limited Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland EU/1/21/1544 Capsule, hard B06AC 4.5.2021 30.4.2021 Sibnayal potassium citrate/potassium hydrogen carbonate ADVICENNE 22, rue de la Paix, 75002 Paris, France EU/1/20/1517 Prolonged-release granules A12BA30 3.5.2021

— 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 7.4.2021 Effentora Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/441 8.4.2021 7.4.2021 Instanyl Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/09/531 8.4.2021 7.4.2021 Trimbow Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/17/1208 8.4.2021 8.4.2021 Vaxzevria AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 8.4.2021 13.4.2021 Aerinaze N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/07/399 16.4.2021 13.4.2021 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München, Deutschland EU/1/13/875 14.4.2021 13.4.2021 Neoclarityn N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/00/161 22.4.2021 13.4.2021 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 14.4.2021 13.4.2021 Orgalutran N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/00/130 16.4.2021 13.4.2021 Vantavo N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/09/572 16.4.2021 14.4.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 14.4.2021 15.4.2021 Natpar Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/15/1078 16.4.2021 15.4.2021 Sarclisa Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/20/1435 16.4.2021 15.4.2021 Xromi Nova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland EU/1/19/1366 16.4.2021 16.4.2021 Cholestagel CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24, 17489 Greifswald, Deutschland EU/1/03/268 27.4.2021 16.4.2021 Dynastat Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/02/209 19.4.2021 16.4.2021 Entecavir Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1227 26.4.2021 16.4.2021 Epidyolex GW Pharma (International) B.V. Databankweg 26, 3821AL Amersfoort, Nederland EU/1/19/1389 20.4.2021 16.4.2021 EVOTAZ Bristol-Myers Squibb/Pfizer EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/15/1025 19.4.2021 16.4.2021 Imvanex Bavarian Nordic A/S Philip Heymans Allé 3, DK-2900 Hellerup, Danmark EU/1/13/855 27.4.2021 16.4.2021 Kyprolis Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1060 20.4.2021 16.4.2021 Macimorelin Consilient Health Consilient Health Ltd 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland EU/1/18/1337 26.4.2021 16.4.2021 Maviret AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/17/1213 20.4.2021 16.4.2021 Pegasys Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/02/221 26.4.2021 16.4.2021 Pelgraz Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/18/1313 20.4.2021 16.4.2021 Pemetrexed Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1034 19.4.2021 16.4.2021 SANCUSO Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/12/766 26.4.2021 16.4.2021 Taxotere Sanofi Mature IP 54 rue La Boétie, 75008, Paris, France EU/1/95/002 29.4.2021 16.4.2021 Xaluprine Nova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland EU/1/11/727 19.4.2021 16.4.2021 Xerava PAION Deutschland GmbH Heussstraße 25, 52078 Aachen, Deutschland EU/1/18/1312 19.4.2021 21.4.2021 Adrovance N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/06/364 26.4.2021 21.4.2021 Avamys GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/07/434 28.4.2021 21.4.2021 CABOMETYX Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/16/1136 22.4.2021 21.4.2021 Fosavance N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/05/310 26.4.2021 21.4.2021 Fycompa Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/12/776 22.4.2021 21.4.2021 INCRELEX Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/07/402 22.4.2021 21.4.2021 Insulin aspart Sanofi Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/20/1447 22.4.2021 21.4.2021 Lyumjev Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/20/1422 22.4.2021 21.4.2021 Macimorelin Consilient Health Consilient Health Ltd 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland EU/1/18/1337 23.4.2021 21.4.2021 Mvasi Amgen Technology (Ireland) UC Pottery Road, Dun Laoghaire, Co. Dublin, Ireland EU/1/17/1246 26.2.2021 21.4.2021 Mvasi Amgen Technology (Ireland) UC Pottery Road, Dun Laoghaire, Co. Dublin, Ireland EU/1/17/1246 22.4.2021 21.4.2021 NUBEQA Bayer AG D-51368 Leverkusen, Deutschland EU/1/20/1432 22.4.2021 21.4.2021 Ontruzant Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/17/1241 23.4.2021 21.4.2021 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 26.4.2021 21.4.2021 Oslif Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/586 22.4.2021 21.4.2021 Pemetrexed Fresenius Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/16/1115 23.4.2021 21.4.2021 Qtern AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1108 22.4.2021 21.4.2021 Ritonavir Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1242 23.4.2021 21.4.2021 RoActemra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/08/492 23.4.2021 21.4.2021 Slenyto RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux, 75002 Paris, France EU/1/18/1318 28.4.2021 21.4.2021 Stocrin Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/99/111 26.4.2021 21.4.2021 Tegsedi Akcea Therapeutics Ireland Ltd Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland EU/1/18/1296 22.4.2021 21.4.2021 Trogarzo Theratechnologies Europe Limited 4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland EU/1/19/1359 26.4.2021 21.4.2021 Valdoxan Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France EU/1/08/499 22.4.2021 21.4.2021 Vosevi Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/17/1223 22.4.2021 22.4.2021 COVID-19 Vaccine Janssen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1525 22.4.2021 26.4.2021 Aerius Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/00/160 30.4.2021 26.4.2021 Atazanavir Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1091 27.4.2021 26.4.2021 Kaftrio Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/20/1468 5.5.2021 26.4.2021 Kalydeco Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/12/782 5.5.2021 26.4.2021 Levetiracetam Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/13/889 28.4.2021 26.4.2021 Saxenda Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/15/992 5.5.2021 28.4.2021 Bortezomib Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/16/1114 29.4.2021 30.4.2021 Benlysta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/11/700 4.5.2021 30.4.2021 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419 4.5.2021 30.4.2021 Dasselta KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/739 4.5.2021 30.4.2021 Desloratadine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/732 3.5.2021 30.4.2021 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/930 4.5.2021 30.4.2021 Kigabeq ORPHELIA Pharma SAS 85 boulevard Saint-Michel, 75005 Paris, France EU/1/18/1302 4.5.2021 30.4.2021 Mylotarg Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/18/1277 4.5.2021 30.4.2021 NULOJIX Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/694 4.5.2021 30.4.2021 Remsima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/13/853 3.5.2021 30.4.2021 Sprycel Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/06/363 4.5.2021 30.4.2021 Strimvelis Orchard Therapeutics (Netherlands) B.V. Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland EU/1/16/1097 4.5.2021 30.4.2021 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 3.5.2021 30.4.2021 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/13/846 3.5.2021

— 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 21.4.2021 PegIntron Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/00/131 26.4.2021

— 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 14.4.2021 Credelio Plus lotilaner / milbemycin oxime Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/21/271 Chewable tablet QP54AB51 15.4.2021 20.4.2021 Ultifend ND IBD Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant) Ceva-Phylaxia Co. Ltd. Szállás u. 5, 1107 Budapest, Magyarország EU/2/21/272 Concentrate and solvent for suspension for injection Pending 22.4.2021

— 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 14.4.2021 Suprelorin VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France EU/2/07/072 19.4.2021 20.4.2021 Convenia Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/06/059 27.4.2021 20.4.2021 Cortavance VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France EU/2/06/069 26.4.2021 20.4.2021 Proteq West Nile Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/11/129 4.5.2021 20.4.2021 Sevohale Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/16/196 28.4.2021 20.4.2021 Zactran Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/08/082 22.4.2021 26.4.2021 Coliprotec F4/F18 Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/16/202 30.4.2021 26.4.2021 Credelio Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/17/206 28.4.2021 26.4.2021 Emdocam Emdoka bvba J. Lijsenstraat 16, 2321 Hoogstraten, België EU/2/11/128 27.4.2021 26.4.2021 Enteroporc Coli Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/20/268 28.4.2021 26.4.2021 Neptra Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/19/246 6.5.2021 26.4.2021 Stelfonta QBiotics Netherlands B.V. Prinses Margrietplantsoen 33, 2595 AM Den Haag, Nederland EU/2/19/248 27.4.2021 26.4.2021 Trocoxil Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/08/084 27.4.2021

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.