Revised SPC: Kaftrio 75 mg 50 mg 100 mg (ivacaftor, tezacaftor, elexacaftor) film-coated tablets

The SPC has been updated to note this regimen is now licensed for the treatment of CF in all patients aged ≥12 years, who have ≥1 F508del mutation in CFTR gene. Information from the Phase III study 445-104 has been added to various sections.

Source:

electronic Medicines compendium