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

News 08/02/2013

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.


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

Start of referral procedures

Combined hormonal contraceptives

Article-31 referral: Combined hormonal contraceptives


PDF icon Referral notification
PDF icon PRAC list of questions
PDF icon Timetable for the procedure
PDF icon 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
PDF icon WC500138654_en.pdf


Press release: European Medicines Agency starts safety review of Diane 35 and its generics


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