Medicine passport

Kalydeco 13 13,4 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
13,4 mg
Form
granulaat
ATC code
R07AX02
Registered in
Netherlands · Vertex Pharmaceuticals (Ireland) Limited
Prescription
Prescription only
RVG
EU/1/12/782

Source: Geneesmiddeleninformatiebank · 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
Kalydeco13.4 mg · GranulePrescription onlyVertex Pharmaceuticals Incorporated51167-770

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
KALYDECO13,4 mg · granulésPrescription onlyVERTEX PHARMACEUTICALS (EUROPE) LIMITED67851912

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.

Switzerland 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Kalydeco 13.4 mg13.4 mg · Prescription onlyVertex Pharmaceuticals (CH) GmbH66169

Source: Zugelassene Packungen Humanarzneimittel (Swissmedic) · 2026-09-30

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/nl/en/medicines/kalydeco-13-13-4-mg-granulaat