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GIVLAARI (Alnylam Australia Pty Ltd)

Product name
GIVLAARI
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.

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