CHMP recommends change to indication for Novoseven in haemophilia.- Novo Nordisk.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product NovoSeven (eptacog alfa (activated)) from Novo Nordisk. The CHMP adopted an extension to an existing indication as follows: NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX more than 5 Bethesda Units (BU) in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration; in patients with acquired haemophilia; in patients with congenital FVII deficiency; and in patients with Glanzmann�s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.