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HEPCLUDEX Gilead Sciences Pty Ltd

Product name
HEPCLUDEX
Accepted date
May-2023
Active ingredients
bulevirtide acetate
Proposed indication
For the treatment of chronic hepatitis delta virus.
Application type
A (new medicine)
Publication date
May-2023
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.

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