Meeting highlights from the PRAC meeting in September 2016


At its meeting held at the end of September 2016, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) adopted a list of outstanding issues to be addressed by the marketing-authorisation holders within the Article-31 referral procedure for gadolinium-containing contrast agents.

PRAC continued the review within two Article-20 procedures (review of SGLT2 inhibitors and direct-acting antivirals for treatment of hepatitis C) as well as within three Article-31 referral procedures (review of factor VIII medicines, review of retinoid medicines and review of modified- and prolonged-release paracetamol medicines).

The PRAC did not initiate or conclude a referral at this meeting.

More information on the September 2016 PRAC meeting can be found here.