PRAC news – December 2013
PRAC started additional review of Iclusig
The Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicine’s Agency (EMA) has started an additional, in-depth review of benefits and risks associated with use of Iclusig in treating leukaemia. The review refers primarily to the risk of blood clots or blockages in the arteries or veins that is associated with the medicinal product.
In November 2013, a number of measures were recommended to help minimise the risk (in Croatian). However, an additional examination is considered necessary in order to investigate issues associated with this risk and to assess whether further changes in use of this medicine are needed.
You may find more information at the EMA webpages, or here.
PRAC adopted a recommendation for Kogenate Bayer and Helixate Nexgen
The PRAC concluded that the benefits of use of Kogenate Bayer and Helixate Nexgen, which are the second generation of factor VIII, continue to outweigh the risks in previously untreated patients with the bleeding disorder of haemophilia A.
More information may be found on the EMA webpages, or here.