PRAC News – June 2016
During its June meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) did not initiate or conclude a safety referral. It discussed four ongoing referrals.
In the Article-20 referral procedures PRAC continued its assessment of canagliflozin as well as direct-acting antivirals for treatment of hepatitis C, whereas in the referral procedure for the medicinal product Zydelig it adopted a list of outstanding issues to be addressed by the marketing authorisation holders.
In the Article-31 referral procedure for gadolinium-containing contrast agents, PRAC adopted a list of outstanding issues to be addressed by the marketing authorisation holders.
More information on the June 2016 PRAC meeting can be found here.