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

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08/02/2013

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

 

Referral notification
PRAC list of questions
Timetable for the procedure
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
Annex I

 

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

 

Related information

Related information

Contact point:

Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu