Agenda of the PRAC meeting 27 - 30 October 2025

EMEA-002712-PIP01-19-M01

EMEA-002287-PIP01-17-M03

Human medicines European public assessment report (EPAR): Fanskya, Mozafancogene autotemcel, Status: Application withdrawn

Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Date of authorisation: 12/09/2013, Revision: 27, Status: Authorised

PSUSA/00010631/202412

Human medicines European public assessment report (EPAR): Adtralza, tralokinumab, Date of authorisation: 17/06/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Date of authorisation: 07/01/2021, Revision: 8, Status: Authorised

Substance, product, organisation and referential (SPOR) master data

HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 October 2025, 10:00 (CEST) to 9 October 2025, 16:10 (CEST)