Reflection paper on investigation and assessment of cardiovascular safety of anticancer medicinal products

Opinion/decision on a Paediatric investigation plan (PIP): Kengrexal, cangrelor (tetrasodium), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Surgical and medical procedures, PIP number: EMA/PE/0000239079

Human medicines European public assessment report (EPAR): Opatanol, olopatadine, Date of authorisation: 16/05/2002, Revision: 26, Status: Authorised

Eighth European Medicines Agency (EMA) and Medicines for Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 15 December 2025, 15:00 (CET) to 15 December 2025, 17:00 (CET)

Fludarabine

Human medicines European public assessment report (EPAR): Erivedge, vismodegib, Date of authorisation: 12/07/2013, Date of refusal: 26/04/2013, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR): Bavencio, avelumab, Date of authorisation: 18/09/2017, Revision: 22, Status: Authorised

New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 July 2025 PRAC

First EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 November 2025, 09:00 (CET) to 5 November 2025, 17:00 (CET)

European Union example instances - E2B(R3) testing files