ESPEROCT (Novo Nordisk Pharmaceuticals Pty Ltd)
Product name
ESPEROCT
Date registered
Evaluation commenced
Decision date
Approval time
144 (175 working days
Active ingredients
turoctocog alfa pegol
Registration type
NCE/NBE
Indication
ESPEROCT, is a long-acting recombinant Factor VIII concentrate indicated for use in previously treated patients with haemophilia A for:
- Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes
- On-demand treatment and control of bleeding episodes
- Peri-operative management of bleeding (surgical prophylaxis)
ESPEROCT does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand’s disease.