Agenda - Medicine Shortages SPOC Working Party meeting 13-14 October 2026

Human medicines European public assessment report (EPAR): Saphnelo, anifrolumab, Date of authorisation: 14/02/2022, Revision: 12, Status: Authorised

Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI)

Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP

Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Date of authorisation: 04/01/2017, Revision: 13, Status: Authorised

CHMP PROM minutes for the meeting on 1 December 2025

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Date of authorisation: 16/01/2009, Revision: 54, Status: Authorised

Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Date of authorisation: 11/05/2016, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Remicade, infliximab, Date of authorisation: 13/08/1999, Revision: 70, Status: Authorised

Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Date of authorisation: 26/09/2019, Revision: 14, Status: Authorised