TAVNEOS (Vifor Pharma Pty Ltd)
Product name
TAVNEOS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
202 (255 working days)
Active ingredients
avacopan
Registration type
NCE/NBE
Indication
Tavneos, in combination with a rituximab or cyclophosphamide based regimen, is indicated for the treatment of adults with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.