PRAC news – December 2013
The Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicine’s Agency (EMA) gave new recommendations for the EU Member States on its meeting held in December 2013, concerning the safe use of medicines.
The PRAC 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.
The PRAC also 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.
Detailed information is available under the following link below.