Medicine passport

Orkambi 200 mg/125 mg 200 mg + 125 mg

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

Active substance
Ivacaftor + Lumacaftor
Strength
200 mg + 125 mg
Form
filmomhulde tablet
ATC code
R07AX30
Registered in
Netherlands · Vertex Pharmaceuticals (Ireland) Limited
Prescription
Prescription only
RVG
EU/1/15/1059

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
Orkambi200 mg + 125 mg · Tablet, Film CoatedPrescription onlyVertex Pharmaceuticals Incorporated51167-809

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

Spain 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
ORKAMBI200 mg/125 mg · comprimido recubierto con películaPrescription onlyVertex Pharmaceuticals (Ireland) Limited1151059001

Source: CIMA — Centro de Información online de Medicamentos (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)) · 2026-09-30 · Fuente: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), CIMA.

France 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
ORKAMBI200 mg + 125 mg · comprimé pelliculéPrescription onlyVERTEX PHARMACEUTICALS (IRELAND)66352529

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.

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/orkambi-200-mg-125-mg-200-mg-125-mg-filmomhulde-tablet