We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
EMPAVELI Swedish Orphan Biovitrum Pty Ltd
Product name
EMPAVELI
Sponsor
Accepted date
Jun-2025
Active ingredients
pegcetacoplan
Proposed indication
EMPAVELI is indicated for the treatment, in adults and adolescents aged 12 to 17 years, of the kidney diseases C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
Application type
C (new indication)
Publication date
Jun-2025
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available.