Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2020 to 31 December 2020

(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2021/C 67/01)

— 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 17.12.2020 Palforzia defatted powder of Arachis hypogaea L., semen (peanuts) Aimmune Therapeutics Ireland Limited Block B, The Crescent Building, Northwood Crescent Northwood, Dublin 9, D09 C6X8 Ireland EU/1/20/1495 White to beige oral powder in capsules for opening or sachet. Pending 21.12.2020

— 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 3.8.2020 Urorec Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/608 14.8.2020 24.9.2020 Evoltra Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/06/334 15.10.2020 24.9.2020 Luminity Lantheus EU Limited Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland EU/1/06/361 12.10.2020 24.9.2020 Matever Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/11/711 25.9.2020 22.10.2020 Zavicefta Pfizer Ireland Pharmaceuticals Operations Support Group, Ringaskiddy, County Cork, Ireland EU/1/16/1109 19.11.2020 27.10.2020 Fabrazyme Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/01/188 13.11.2020 27.10.2020 TRISENOX Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/02/204 29.10.2020 5.11.2020 Elaprase Shire Human Genetic Therapies AB Vasagatan 7, 111 20 Stockholm, Sverige EU/1/06/365 12.2.2021 16.11.2020 Ondexxya Alexion Europe SAS 103-105 Rue Anatole France, 92300 Levallois-Perret, France EU/1/18/1345 4.12.2020 20.11.2020 Fampyra Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/11/699 4.12.2020 20.11.2020 Humira AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/03/256 23.11.2020 25.11.2020 Triumeq ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/14/940 7.12.2020 9.12.2020 Caprelsa Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/11/749 21.1.2021 14.12.2020 Efient Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/08/503 16.12.2020 14.12.2020 Hulio Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1319 15.12.2020 14.12.2020 Revolade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/612 13.12.2020 14.12.2020 Thyrogen Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/99/122 17.12.2020 14.12.2020 Tolucombi KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/13/821 17.12.2020 17.12.2020 Chenodeoxycholic acid Leadiant Leadiant GmbH Liebherrstr. 22, 80538 Munich, Deutschland EU/1/16/1110 15.1.2021 17.12.2020 Darunavir Krka KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1249 21.1.2021

— 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 30.10.2020 Meloxidolor Le Vet Beheer B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/13/148 3.11.2020 20.11.2020 Cepedex CP Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf, Deutschland EU/2/16/200 21.12.2020

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.