ICATIBANT MYLAN (Alphapharm Pty Ltd)
Product name
ICATIBANT MYLAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
158 (255 working days)
Active ingredients
icatibant
Registration type
New generic medicine
Indication
ICATIBANT MYLAN (solution for injection) is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults 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