News and Educations

Meeting highlights from the PRAC meeting in January 2017


At its meeting held in January 2017, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) adopted a list of experts who will be consulted in the review within the Article-31 referral procedure for factor VIII medicines as well as a list of questions for the targeted meeting with patients and healthcare professionals (HCP) within the Article-31 referral procedure for retinoid medicines.
PRAC continued the review within Article-31 referral procedures for injectable medicines for treatment of allergic reactions that contain lactose from cows' milk, gadolinium-containing contrast agents and modified- and prolonged-release paracetamol medicines as well as the review within the Article-20 procedure for SGLT2 inhibitors.

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

The PRAC also focused on the broad spectrum of its responsibilities which cover all aspects of the risk management of the use of medicines.

More information on the PRAC January 2017 meeting can be found here.