Medicine passport

KALYDECO 150 mg

The same active substance, strength and form as listed by each country’s medicines regulator. For showing a pharmacist abroad.

Active substance
Ivacaftor
Strength
150 mg
Form
comprimido recubierto con película
ATC code
R07AX02
Registered in
Spain · Vertex Pharmaceuticals (Ireland) Limited
Prescription
Prescription only
Nº Registro
112782002

Source: CIMA — Centro de Información online de Medicamentos · 2026-09-30

Not a prescription. Not a statement that these products are interchangeable. Products are matched on active substance, strength and kind of form only. Other ingredients, release, approved uses and the dose on the box can differ. A pharmacist or doctor decides whether one can replace another.

Listed in other countries

United States 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Kalydeco150 mg · Tablet, Film CoatedPrescription onlyVertex Pharmaceuticals Incorporated51167-200

Source: NDC Directory (US Food and Drug Administration) · 2026-09-13 · Source: US Food and Drug Administration, NDC Directory.

France 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
KALYDECO150 mg · comprimé pelliculéPrescription onlyVERTEX PHARMACEUTICALS (IRELAND)65036318

Source: Base de données publique des médicaments (ANSM / Ministère de la Santé) · 2026-09-30 · Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte.

Canada 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
KALYDECO150 mg · tabletPrescription onlyVertex Pharmaceuticals (Canada) Incorporated02397412

Source: Drug Product Database (Health Canada) · 2026-09-30 · Contains information licensed under the Open Government Licence – Canada.

Netherlands 7 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Ivacaftor Aurobindo 150 mg150 mg · filmomhulde tabletPrescription onlyAurobindo Pharma B.V.135043
Ivacaftor Intas 150 mg filmomhulde tabletten150 mg · filmomhulde tabletPrescription onlyIntas Third Party Sales 2005, S.L.133655
Ivacaftor STADA 150 mg150 mg · filmomhulde tabletPrescription onlyStada Arzneimittel AG134168
Ivacaftor SUN 150 mg filmomhulde tabletten150 mg · filmomhulde tabletPrescription onlySun Pharmaceutical Industries Europe B.V.133748
Ivacaftor Teva 150 mg150 mg · filmomhulde tabletPrescription onlyTeva B.V.135293
Ivafib 150 mg filmomhulde tabletten150 mg · filmomhulde tabletPrescription onlyG.L. Pharma GmbH135059

1 more names not shown. Source: Geneesmiddeleninformatiebank (College ter Beoordeling van Geneesmiddelen (CBG-MEB)) · 2026-09-30 · Bron: College ter Beoordeling van Geneesmiddelen (CBG). De Rijksoverheid is het niet automatisch eens met de inhoud van deze site.

Same active substance, but no match for this strength and form

Countries covered: United States, Bulgaria, European Union, Spain, France, Netherlands, Canada, Switzerland. A country missing from the list may still sell this medicine: Mediclarum reads only these registers.

Register data as of 2026-09-30. Mediclarum stores nothing about you for this page. https://www.mediclarum.com/es/en/medicines/kalydeco-150-mg-comprimido-recubierto-con-pelicula-cf2311