News and Educations

PRAC News - December 2015

04.12.2015

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.

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