Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2013

News 17/05/2013

PRAC recommendation on Diane 35 and generics

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks in a specific patient group, provided that several measures are taken to minimise the risk of thromboembolism, including new contraindications and warnings.

The Committee adopted the recommendation following a thorough review in which it sought expert advice and considered feedback from healthcare professionals and users of these medicines.

The PRAC's recommendation will now be considered by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which will take a final position. The CMDh is a regulatory body that represents national medicines regulatory authorities of the European Union (EU) Member States.

Links to the summary of the PRAC recommendation and to a press release are available in the table below.

PRAC recommends withdrawal of oral almitrine-containing medicines

The PRAC concluded that the benefits of almitrine-containing medicines no longer outweigh their risks, and recommended that all marketing authorisations for these medicines should be withdrawn across the EU.

Two new referral procedures started in May 2013

The PRAC started a review of Protelos / Osseor, a medicine containing strontium ranelate used for treating osteoporosis. The review has been started following a recent routine evaluation of safety data showing an increased risk of serious heart problems, including heart attack, with the medicine.

A review of the combined use of renin-angiotensin-system (RAS)-acting agents was also started by the PRAC.

Other updates

The review of third- and fourth-generation combined hormonal contraceptives continues. An update from the PRAC is expected in July 2013.

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


PDF icon Agenda - PRAC draft agenda of meeting 13-16 May 2013

Start of referral procedures

Protelos / Osseor

Protelos / Osseor: Article-20 procedure


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


RAS-acting agents

RAS-acting agents: Article-31 referral


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


Recommendations by PRAC

Cyproterone / ethinylestradiol-containing medicines

Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure


Summary of PRAC recommendation
PDF icon Press release


Almitrine-containing medicines

Almitrine-containing medicines: Article-31 referral


PDF icon Summary of PRAC recommendation


Related content

How useful was this page?

Add your rating