Revised SPC: Kalydeco (ivacaftor) 150 mg Film-coated Tablets

SPC updated to note this is licensed for use in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of CF in all patients aged ≥12 years, who have ≥1 F508del mutation in CFTR gene. Further efficacy data from Study 6 have also been added.

Source:

electronic Medicines compendium