Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 February 2013

8 February 2013

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) held its seventh meeting from 4 to 7 February 2013.

For an overview of all information available following the meeting of the PRAC, please see the table below.

The Agency publishes a new page following the PRAC meeting each month. The minutes of each PRAC meeting will be published during the week following the subsequent PRAC.

Agenda

Agenda - PRAC draft agenda of meeting 4-7 February 2013

Start of referral procedures

Combined hormonal contraceptives
Article-31 referral: Combined hormonal contraceptives   Combined hormonal contraceptives: Article-31 referral - Notification Combined hormonal contraceptives: Article-31 referral - PRAC list of questions Combined hormonal contraceptives: Article-31 referral - Timetable for the procedure Combined hormonal contraceptives Article-31 referral - Annex I

 

Cyproterone- and ethinylestradiol-containing medicines
Article-107i procedure: Cyproterone- and ethinylestradiol-containing medicines   Referral notification PRAC list of questions to be addressed by stakeholders Stakeholders' submission form Timetable for the procedure Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - Annex I   Press release: European Medicines Agency starts safety review of Diane 35 and its generics