EMA European Union — centrally authorised medicines
Kaftrio Vertex Pharmaceuticals (Ireland) Limited · Authorised · authorised 21 Aug 2020 · ATC R07AX32
Therapeutic indication (EMA)
Kaftrio tablets are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Kaftrio granules are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| TRIKAFTA | 02517140 | 75 MG; 150 MG; 100 MG; 50 MG | TABLET · ORAL | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED |
| TRIKAFTA | 02526670 | 50 MG; 25 MG; 37.5 MG; 75 MG | TABLET · ORAL | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED |
| TRIKAFTA | 02542277 | 75 MG; 100 MG; 50 MG | GRANULES · ORAL | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED |
| TRIKAFTA | 02542285 | 40 MG; 60 MG; 59.5 MG; 80 MG | GRANULES · ORAL | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED |
WHO WHO Model List of Essential Medicines (2025)
- 7. Medicines for cystic fibrosis · core
Cystic fibrosis
Oral > Solid > tablet: 50 mg + 25 mg + 37.5 mg; 100 mg + 50 mg + 75 mg | Oral > Solid > granules: 80 mg + 40 mg + 60 mg in sachet; 100 mg + 50 mg + 75 mg in sachet
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.