News and Educations

PRAC News – August 2016


At its meeting held at the end of August and the beginning of September 2016, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) discussed the ongoing Article-31 referral procedure for retinoid medicines.

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 gadolinium-containing contrast agents 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 August 2016 PRAC meeting can be found here.