FABHALTA (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
FABHALTA
Date registered
Evaluation commenced
Decision date
Approval time
142 (255 working days)
Active ingredients
iptacopan
Registration type
EOI
Indication
FABHALTA is indicated for the treatment of adult patients with:
- complement 3 glomerulopathy (C3G)
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.