Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 December 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.
|Agenda - PRAC draft agenda of meeting 2-5 December 2013|
Start of referral procedure
Recommendation by PRAC
|Kogenate Bayer and Helixate NexGen (octocog alfa)|
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- Kogenate Bayer and Helixate NexGen
- Diacerein-containing medicines for oral administration
- Further review of Iclusig started (6/12/2013)
- PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously untreated patients (6/12/2013)
- Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 December 2013
- Acronyms and abbreviations used in PRAC minutes (22/07/2014)
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