EMPAVELI (Apellis Australia Pty Ltd)
Product name
EMPAVELI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
243 (255 working days)
Active ingredients
pegcetacoplan
Registration type
NCE/NBE
Indication
EMPAVELI (solution for injection) is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.