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/ethinylestradiol (2mg/0.035mg) containing medicinal products

Article 107i referral: Cyproterone/ethinylestradiol (2mg/0.035mg) containing medicinal products

 

Referral notification
PRAC list of questions to be addressed by the stakeholders
Stakeholders’ submission form
Timetable for the procedure
Annex I

 

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

 

Posted on the EMA website on 11 February 2013