New product information wording – Extracts from PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC

PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC meeting

List of signals discussed at PRAC since September 2012

EMEA-003184-PIP01-22

Agenda - Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods

EMEA-003080-PIP03-22

Change management activities delivery plan

Workplan 2023-2025: HMA-EMA joint Big Data Steering Group

EMEA-002612-PIP02-22

Opinion/decision on a Paediatric investigation plan (PIP): Evusheld, tixagevimab,cilgavimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Infectious diseases, PIP number: P/0119/2023