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

News 09/10/2015

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

PDF iconAgenda - 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

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