Tezacaftor
Active ingredient
Sold as Symkevi · SYMDEKO
- Drug class
- -
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 4
Overview
Tezacaftor is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 2 | May 22, 2026 |
| EU European Union | EMA | 1 | December 8, 2025 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
2 products
Uses
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.
How to take
EUEuropean Union· EMA
1 product
Uses
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.
How to take
CACanada· Health Canada
1 product
Uses
SYMDEKO (tezacaftor/ivacaftor and ivacaftor) is indicated for the treatment of patients with cystic fibrosis (CF) aged 12 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, D110H, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.
1 Pediatrics Pediatrics (<12 years of age): No data in patients less than 12 years of age are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use in this age group. 2 Geriatrics Geriatrics (>65 years of age): Clinical trials of SYMDEKO did not include sufficient numbers of patients 65 years of age and over to determine whether they respond differently from younger patients.
Sources & citations
- [1]MHRA (UK) · PLGB223520003 · revised May 22, 2026
- [2]European Medicines Agency · EMEA/H/C/004682 · revised December 8, 2025
- [3]Health Canada (DPD) · 02478080 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.