CHMP recommends approval of NovoSeven in haemophilia.- Novo Nordisk
The full indications for NovoSeven will therefore be 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 > 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; in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available. NovoSeven is indicated for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis.
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