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

Human medicines European public assessment report (EPAR): Darzalex, daratumumab, Date of authorisation: 20/05/2016, Revision: 26, Status: Authorised

Human medicines European public assessment report (EPAR): Imbruvica, ibrutinib, Date of authorisation: 21/10/2014, Revision: 36, 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)

List of signals discussed at PRAC since September 2012

PRAC recommendations on signals adopted at the 29 September - 2 October 2025 PRAC meeting