Notice for tezacaftor/ivacaftor (Vertex Pharmaceuticals Australia Pty Ltd)
Active ingredients
tezacaftor/ivacaftor
Date of review outcome
Lapse date
Type
Orphan drug
Dosage form(s)
Tablet, film-coated
Indication
For the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.