FABHALTA (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
FABHALTA
Date registered
Evaluation commenced
Decision date
Approval time
212 (255 working days)
Active ingredients
iptacopan
Registration type
NCE/ NBE
Indication
FABHALTA is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.