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).