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TRIKAFTA (Vertex Pharmaceuticals Australia Pty Ltd)

Product name
Date registered
Evaluation commenced
Decision date
Approval time
187 (255 working days)
Active ingredients
elexacaftor, ivacaftor, tezacaftor
Registration type

TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Registration process

Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.

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