PRAC News – October 2015
During its October meeting, the Pharmacovigilance and Risk Assessment Committee (PRAC) discussed three ongoing referrals in the EU. The PRAC did not initiate or conclude a safety referral.
The review under Article 20 of SGLT2 inhibitors which are medicines known used to treat type 2 diabetes, the PRAC adopted a list of outstanding issues for marketing authorisation holders and has updated the referral timetable.
The review under Article 20 of the Human Papilloma Virus (HPV) vaccines, the PRAC adopted a list of questions to the scientific advisory group.
The review under Article 20 of Tsysabri, the PRAC continued its assessment.
Further information on the PRAC October 2015 Meeting is accessible here.