Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 October 2015

9 October 2015

During its October meeting, the PRAC discussed three ongoing referrals. More information is included in the table below. The PRAC did not initiate or conclude a safety referral.

Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting in November 2015.

Agenda

Agenda - PRAC draft agenda of meeting 5-8 October 2015

Product	Procedure	Status	Update in October 2015
SGLT2 inhibitors	Article-20 procedure: SGLT2 inhibitors	Under evaluation	PRAC adopted a list of outstanding issues and has updated the referral timetable
Human papillomavirus (HPV) vaccines	Article-20 procedure: Human papillomavirus (HPV) vaccines	Under evaluation	PRAC adopted a list of questions to the scientific advisory group
Tysabri	Article-20 procedure: Tysabri	Under evaluation	PRAC continued its assessment