Orphan designation: (S)-1-(4-(1-(3,4,5-trimethoxyphenyl)-1H-imidazol-4-ylamino)thieno[2,3-d]pyrimidin-2-yl)pyrrolidine-2-carboxamide Treatment of fibrodysplasia ossificans progressiva, 18/07/2022 Withdrawn

Referral: Levamisole-containing medicinal products, levamisole, associated names: Decaris,Levamisol Arena Article 31 referrals CMDh final position, 13/05/2026

Human medicines European public assessment report (EPAR): Lucentis, ranibizumab, Date of authorisation: 22/01/2007, Revision: 48, Status: Authorised

Tecovirimat SIGA

Ontozry

Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Date of authorisation: 01/07/2013, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR): EndolucinBeta, lutetium (177Lu) chloride, Date of authorisation: 06/07/2016, Revision: 11, Status: Authorised

Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)

Timetable: Initial (full) marketing authorisation application accelerated assessment timetables

Timetable: Initial (Full) marketing authorisation application - ATMP