Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2025
Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2025 to 16 May 2025
PSUSA/00010605/202407
PSUSA/00010252/202406
PSUSA/00009236/202406
PSUSA/00000342/202407
Human medicines European public assessment report (EPAR): Bortezomib Fresenius Kabi, bortezomib, Date of authorisation: 14/11/2019, Revision: 7, Status: Authorised
Human medicines European public assessment report (EPAR): Docetaxel Accord, docetaxel, Date of authorisation: 22/05/2012, Revision: 19, Status: Authorised
EMEA-003174-PIP01-21-M01