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ONPATTRO (Alnylam Australia Pty Ltd)
Product name
ONPATTRO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
157 (255 working days)
Active ingredients
patisiran
Registration type
NCE/NBE
Indication
ONPATTRO 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.