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Kaftrio

Active substance: ivacaftor, tezacaftor, elexacaftor

ivacaftor, tezacaftor, elexacaftor

Centralised EU authorisationActive

Marketing holder: Vertex Pharmaceuticals (Ireland) Limited

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Products containing ivacaftor in other countries

Showing products with this active substance, combinations included; the full composition is shown for each product.

CountryProducts
US 11
  • Kalydeco
    GRANULE · IVACAFTOR 13.4 mg/1
    51167-770
    Vertex Pharmaceuticals Incorporated
  • Kalydeco
    GRANULE · IVACAFTOR 50 mg/1
    51167-300
    Vertex Pharmaceuticals Incorporated
  • Kalydeco
    TABLET, FILM COATED · IVACAFTOR 150 mg/1
    51167-200
    Vertex Pharmaceuticals Incorporated
  • Kalydeco
    GRANULE · IVACAFTOR 5.8 mg/1
    51167-785
    Vertex Pharmaceuticals Incorporated
  • Kalydeco
    GRANULE · IVACAFTOR 75 mg/1
    51167-400
    Vertex Pharmaceuticals Incorporated
All products in this country (11)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-6d6d-75dc-bc9a-3dc2d4a7db3a,01a1208d-349f-73cc-ac9e-4b3179201d08,01a1208e-641c-74cc-a539-688a62fb860b,01a1208e-6426-754f-9879-db0948bd2584,01a12091-bdba-75b8-8f00-3f6ec295657b;count=6 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005269
Registration status
Active
ATC code
R07AX32
Sources
  • product · EMA · EMEA/H/C/005269 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005269 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005269 · Verified 2026-10-09
  • ingredients.1 · EMA · EMEA/H/C/005269 · Verified 2026-10-09
  • ingredients.2 · EMA · EMEA/H/C/005269 · Verified 2026-10-09