News and Educations

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.