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ANDEMBRY (CSL Behring Australia Pty Ltd)
Product name
ANDEMBRY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
179 (255 working days)
Active ingredients
garadacimab
Registration type
NCE/ NBE
Indication
ANDEMBRY® is indicated for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients aged 12 years and older with C1-INH HAE (C1-esterase inhibitor deficiency or dysfunction).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.