CIPLA ICATIBANT, ICATICIP, ICAZYR (Cipla Australia Pty Ltd)
Product name
CIPLA ICATIBANT, ICATICIP, ICAZYR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
164 working days (255)
Active ingredients
icatibant acetate
Registration type
New generic medicine
Indication
CIPLA ICATIBANT, ICATICIP, ICAZYR (solution for injection) are 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
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine