HEMLIBRA (Roche Products Pty Ltd)
Product name
HEMLIBRA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
122 working days (255)
Active ingredients
emicizumab
Registration type
EOI
Indication
HEMLIBRA (solution for injection vial) is now 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 or without 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