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

Human medicines European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm, dimethyl fumarate, Date of authorisation: 22/04/2024, Revision: 1, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Ervebo, Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations;Vaccines, PIP number: P/0495/2023