Kaftrio
What Kaftrio is used for
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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Kaftrio
- Active substance
- ivacaftor;tezacaftor;elexacaftor
- Disease area
- Cystic Fibrosis
- Medicine group
- Other respiratory system products
- ATC code
- R07AX32
- Marketing authorisation holder
- Vertex Pharmaceuticals (Ireland) Limited
- Authorised in the EU since
- 2020
Official information
In the USA
Same active substance: Alyftrek
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Kaftrio used for?
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.
What is the active substance in Kaftrio?
Kaftrio contains ivacaftor;tezacaftor;elexacaftor.
Who makes Kaftrio?
The EU marketing authorisation holder is Vertex Pharmaceuticals (Ireland) Limited.
Is Kaftrio an orphan medicine?
Yes. Kaftrio is designated an orphan medicine in the EU, for a rare disease (Cystic Fibrosis).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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