HEMLIBRA (Roche Products Pty Limited)
Product name
HEMLIBRA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
104 working days (255)
Active ingredients
emicizumab (rch)
Registration type
NCE/NBE
Indication
HEMLIBRA is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.