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.


Start of referral procedures


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


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