ALHEMO (Novo Nordisk Pharmaceuticals Pty Ltd)
Product name
ALHEMO
Date registered
Evaluation commenced
Decision date
Approval time
141 (255 working days)
Active ingredients
concizumab
Registration type
NCE/NBE
Indication
Alhemo is indicated where prophylaxis is required to prevent or reduce the frequency of bleeding in patients at least 12 years of age who have haemophilia B (congenital factor IX [FIX] deficiency) with FIX 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.