We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
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.