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PRAC meeting highlights 26-29 September 2022

26/09/2022
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 2022 meeting describes new measures for terlipressin-containing medicines in the treatment of hepatorenal syndrome, outlines warnings for serious renal and gastrointestinal harms associated with use of codeine with ibuprofen combination medicines, and ducments new risk minimisation measures for Imbruvica (ibrutinib).