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

Second European Medicines Agency (EMA) and COCIR bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 7 October 2024

Human medicines European public assessment report (EPAR): Emend, aprepitant, Date of authorisation: 11/11/2003, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR): Sylvant, siltuximab, Date of authorisation: 22/05/2014, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Venclyxto, venetoclax, Date of authorisation: 04/12/2016, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Ozurdex, dexamethasone, Date of authorisation: 26/07/2010, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 5, Status: Authorised