JIVI (Bayer Australia Ltd)
Product name
JIVI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
165 (175 working days)
Active ingredients
damoctocog alfa pegol, water for injections
Registration type
NCE/NBE
Indication
Jivi, damoctocog alfa pegol, is a long-acting recombinant Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia A for:
- Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes
- On-demand treatment and control of bleeding episodes
- Per-operative management of bleeding (surgical prophylaxis)
Jivi does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand’s disease.