EN Official Journal of the European Union C 28/11

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2016 to 31 December 2016

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2017/C 028/02)

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorization Member State concerned Date of notification 5.12.2016 Pharmaceutics International Inc — Art 31 Not applicable See annex I See annex I 7.12.2016 12.12.2016 Metformin — Art 31 metformin See annex II See annex II 12.12.2016

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I List of nationally authorised medicinal products Lutinus and associated names Member State in EU/EEA Product name Marketing authorisation holder INN Strength Pharmaceutical form Route of administration Bulgaria Lutinus Ferring Arzneimittel Gmbh Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Czech Republic Lutinus Ferring-Léčiva, a.s. Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Denmark Lutinus Ferring Lægemidler A/S Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Finland Lutinus Ferring Lääkkeet Oy Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Germany Lutinus Ferring Arzneimittel Gmbh Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Greece Lutinus Ferring Hellas Mepe Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Hungary Lutinus Ferring Magyarország Gyógyszerkereskedelmi Kft. Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Iceland Lutinus Ferring Lægemidler A/S Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Ireland Lutinus Ferring Ireland Ltd Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Netherlands Lutinus Ferring B.V. Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Norway Lutinus Ferring Legemidler As Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Poland Lutinus Ferring Gmbh Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Portugal Luferti Ferring Portuguesa — Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Romania Lutinus Ferring Gmbh Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Slovakia Lutinus Ferring Léciva A.S. Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Slovenia Lutinus Ferring Gmbh Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Spain Lutinus Ferring S.A.U. Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Sweden Lutinus Ferring Läkemedel Ab Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE United Kingdom Lutigest Ferring Pharmaceuticals Ltd Progesterone PROGESTERONE 100 MG TABLET VAGINAL TABLET VAGINAL USE Dutasteride Actavis and associated names Member State in EU/EEA Product name Marketing authorisation holder INN Strength Pharmaceutical form Route of administration Austria Dutasterid Actavis Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Bulgaria Caminard Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Croatia Caminard Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Czech Republic Dutasterid Actavis Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Denmark Dutasteride Actavis Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Estonia Dutasteride Actavis Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Iceland Dutasteride Actavis Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Ireland Dutasteride Actavis Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Latvia Dutasteride Actavis Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Lithuania Dutasteride Actavis Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Norway Dutasteride Actavis Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Poland Dudactiv Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Romania Dutasteridă Actavis Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE Slovenia Dutelas Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE United Kingdom Dutasteride Actavis Group Actavis Group Ptc Ehf. Dutasteride DUTASTERIDE 0,5 MG CAPSULE CAPSULE, SOFT ORAL USE SoliCol D3 Member State in EU/EEA Product name Marketing authorisation holder INN Strength Pharmaceutical form Route of administration United Kingdom SoliCol D3 Pharmaceutics (UK) Limited Colecalciferol COLECALCIFEROL 50,000 IU TABLET ORAL USE United Kingdom SoliCol D3 Pharmaceutics (UK) Limited Colecalciferol COLECALCIFEROL 20,000 IU TABLET ORAL USE