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FIRAZYR (Shire Australia Pty Ltd)
Product name
FIRAZYR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
217 working days (255)
Active ingredients
icatibant (as acetate)
Registration type
EOI
Indication
FIRAZYR (solution for injection) is now indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase-inhibitor deficiency.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.