PRAC meeting highlights 25-28 September 2023
25/09/2023
Medicines for human use
Pharmacovigilance risk assessment committee (PRAC)
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring safety issues for human medicines.
The current PRAC highlights from the September 2023 meeting describes new safety information for Omega-3-acid ethyl estersthe and the risk of atrial fibrillation (irregular, rapid contraction of the heart) as a common side effect.