Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 December 2013

News 06/12/2013

PRAC initiates further review of Iclusig

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has started a further in-depth review of the benefits and risks of the leukaemia medicine Iclusig, particularly the risk of blood clots or blockages in the arteries or veins that is associated with the medicine.

The Agency had recommended in November 2013 a number of measures to help minimise this risk, however an additional review was considered necessary to further investigate issues related to this risk and to assess the need for further changes to how the medicine is used.

PRAC recommendation on Kogenate Bayer and Helixate NexGen

The PRAC concluded that the benefits of Kogenate Bayer and Helixate NexGen, which are second-generation factor VIII products, continue to outweigh the risks in previously untreated patients with the bleeding disorder haemophilia A.

Request for re-examination of the PRAC recommendation on diacerein-containing medicines

Some marketing-authorisation holders for diacerein-containing medicines have requested a re-examination of the PRAC's November 2013 recommendation to suspend these medicines. Upon receipt of the scientific grounds of the requests, the PRAC will re-examine its recommendation and issue a final recommendation.

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


PDF icon Agenda - PRAC draft agenda of meeting 2-5 December 2013

Start of referral procedure

Iclusig (ponatinib)

Article-20 procedure: Iclusig (ponatinib)

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

Recommendation by PRAC

Kogenate Bayer and Helixate NexGen (octocog alfa)

Article-20 procedure: Kogenate Bayer and Helixate NexGen (octocog alfa)

PDF icon Summary of PRAC recommendation

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