PRAC News - December 2015
During its December meeting, the PRAC discussed two ongoing referrals. The PRAC did not initiate or conclude a safety referral.
In the Article-20 referral procedure for Tysabri, a medicinal product for treatment of multiple sclerosis, PRAC discussed feedback from the Scientific Advisory Group (SAG) and adopted a list of outstanding issues for the marketing authorisation holder.
In the Article-31 referral procedure for medicinal products containing fusafungine, an antibiotic for local use, PRAC adopted a list of outstanding issues for the Scientific Advisory Group.
More information on the December 2015 PRAC meeting is accessible here.