Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022 (Decisions taken pursuant to Article 34 of Directive 2001/83/...

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1), Article 38 of Directive 2001/82/EC (2) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3)) (2022/C 457/02) — Issuing, maintenance or modification of a national marketing authorisation Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) 28.10.2022 Nomegestrol and Chlormadinone nomegestrol or chlormadinone (1) OJ L 311, 28.11.2001, p. 67. (2) OJ L 311, 28.11.2001, p. 1. (3) OJ L 4, 7.1.2019, p. 43. Holder(s) of the marketing authorisation Member State concerned Date of notification See Annex See Annex 31.10.2022 ANNEX List of nationally authorised medicinal products Nationally authorised medicinal products containing nomegestrol C 457/10 EN Official Journal of the European Union 30.11.2022 Member State in EEA Marketing Authorisation Holder Product Name INN/Active Substance + Strength Pharmaceutical Form Route of Administration Belgium Ceres Pharma Nv Nogest Nomegestrol Acetate 5 mg Tablet Tablet Oral Use Belgium Stragen Nordic A/S Nomegestrol Stragen Nomegestrol Acetate 5 mg Tablet Tablet Oral Use Belgium Theramex Ireland Limited Lutenyl Nomegestrol Acetate 5 mg Tablet Tablet Oral Use Belgium Theramex Ireland Limited Naemis Estradiol Hemihydrate 1,55 mg Tablet...