Agenda of the PRAC meeting 27 - 30 October 2025
Submitted by Anonymous (not verified) on 27 October 2025 - 16:27
Agenda of the PRAC meeting 27 - 30 October 2025
EMEA-002712-PIP01-19-M01
Submitted by Anonymous (not verified) on 27 October 2025 - 16:25
EMEA-002712-PIP01-19-M01
EMEA-002287-PIP01-17-M03
Submitted by Anonymous (not verified) on 27 October 2025 - 16:20
EMEA-002287-PIP01-17-M03
Human medicines European public assessment report (EPAR): Fanskya, Mozafancogene autotemcel, Status: Application withdrawn
Submitted by Anonymous (not verified) on 27 October 2025 - 16:12
Human medicines European public assessment report (EPAR): Fanskya, Mozafancogene autotemcel, Status: Application withdrawn
PSUSA/00010631/202412
Submitted by Anonymous (not verified) on 27 October 2025 - 14:35
PSUSA/00010631/202412
Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Date of authorisation: 07/01/2021, Revision: 8, Status: Authorised
Submitted by Anonymous (not verified) on 27 October 2025 - 14:00
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
Submitted by Anonymous (not verified) on 27 October 2025 - 9:55
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)
Submitted by Anonymous (not verified) on 27 October 2025 - 7:31
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
Submitted by Anonymous (not verified) on 27 October 2025 - 7:23
List of signals discussed at PRAC since September 2012
PRAC recommendations on signals adopted at the 29 September - 2 October 2025 PRAC meeting
Submitted by Anonymous (not verified) on 27 October 2025 - 7:18
PRAC recommendations on signals adopted at the 29 September - 2 October 2025 PRAC meeting