GIVLAARI (Alnylam Australia Pty Ltd)
Product name
GIVLAARI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
157 (175 working days)
Active ingredients
givosiran sodium
Registration type
NCE/NBE
Indication
Givlaari is indicated for the treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.