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.