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

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09/10/2015

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

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