Orphan designation: Fosmanogepix Treatment of invasive candidiasis, 18/07/2022 Positive
Orphan designation: erlotinib Treatment of pachyonychia congenita, 18/07/2022 Positive
Orphan designation: Fosmanogepix Treatment of scedosporiosis, 20/03/2023 Positive
Orphan designation: Fosmanogepix Treatment of lomentosporiosis, 15/02/2023 Positive
Orphan designation: Fosmanogepix Treatment of mucormycosis, 15/02/2023 Positive
EMEA-003220-PIP01-22
Human medicines European public assessment report (EPAR): Evrysdi, risdiplam, Date of authorisation: 26/03/2021, Revision: 9, Status: Authorised
CHMP PROM minutes for the meeting on 15 July 2024
Human medicines European public assessment report (EPAR): Ilumetri, tildrakizumab, Date of authorisation: 17/09/2018, Revision: 13, Status: Authorised
Improving efficiency of approval process for new medicines in the EU