Symkevi
What Symkevi is used for
Symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A-G, S945L, S977F, R1070W, D1152H, 2789+5G-A, 3272 26A-G, and 3849+10kbC-T.
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
- Symkevi
- Active substance
- tezacaftor;ivacaftor
- Disease area
- Cystic Fibrosis
- Medicine group
- Other respiratory system products
- ATC code
- R07AX31
- Marketing authorisation holder
- Vertex Pharmaceuticals (Ireland) Limited
- Authorised in the EU since
- 2018
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 Symkevi used for?
Symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A-G, S945L, S977F, R1070W, D1152H, 2789+5G-A, 3272 26A-G, and 3849+10kbC-T.
What is the active substance in Symkevi?
Symkevi contains tezacaftor;ivacaftor.
Who makes Symkevi?
The EU marketing authorisation holder is Vertex Pharmaceuticals (Ireland) Limited.
Is Symkevi an orphan medicine?
Yes. Symkevi 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.
← All specialty medicines, EU