HEPCLUDEX (Gilead Sciences Pty Ltd)
Product name
HEPCLUDEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
160 (255 working days)
Active ingredients
bulevirtide acetate
Registration type
NCE/ NBE
Indication
HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.