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.
AMVUTTRA, (Medison Pharma Australia Pty Ltd)
Product name
AMVUTTRA,
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
134 (255 working days)
Active ingredients
vutrisiran sodium
Registration type
NCE/NBE
Indication
Amvuttra is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.