Symkevi
·
- Prescription status not stated
- Breathing, airways, allergies and cough
- Active substance
- Tezacaftor;ivacaftor
- Made by
- Vertex Pharmaceuticals (Ireland) Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is 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.
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Vertex Pharmaceuticals (Ireland) Limited |
|---|---|
| Active substance | Tezacaftor;ivacaftor |
| Used in | Breathing, airways, allergies and cough |
| Classification | R07AX31 · Breathing, airways, allergies and cough |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Authorised on | 2018-10-31 |
| Last updated by the regulator | 2025-12-08 |
| EMA product number | EMEA/H/C/004682 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).