ICATIBANT LUPIN, ICATIBANT LAPL, ICATIBANT GH (Generic Health Pty Ltd)
Product name
ICATIBANT LUPIN, ICATIBANT LAPL, ICATIBANT GH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
120 (255 working days)
Active ingredients
icatibant acetate
Registration type
New generic medicine
Indication
ICATIBANT LUPIN, ICATIBANT LAPL, ICATIBANT GH (solution for injection pre-filled syringe) 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.