FYZANT (Juno Pharmaceuticals Pty Ltd)
Product name
FYZANT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
120 (255 working days)
Active ingredients
icatibant (as acetate)
Registration type
New generic medicine
Indication
FYZANT (solution for injection) is 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.