Orkambi

Active substance: Lumacaftor, ivacaftor

Lumacaftor, ivacaftor

Centralised EU authorisationActive

Marketing holder: Vertex Pharmaceuticals (Ireland) Limited

Verified 2026-10-09 · EMA

Composition

Products containing lumacaftor in other countries

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

Country	Products
US 5	ORKAMBI TABLET, FILM COATED · LUMACAFTOR 100 mg/1, IVACAFTOR 125 mg/1 51167-700 Vertex Pharmaceuticals Incorporated ORKAMBI TABLET, FILM COATED · LUMACAFTOR 200 mg/1, IVACAFTOR 125 mg/1 51167-809 Vertex Pharmaceuticals Incorporated ORKAMBI GRANULE · LUMACAFTOR 75 mg/1, IVACAFTOR 94 mg/1 51167-122 Vertex Pharmaceuticals Incorporated ORKAMBI GRANULE · LUMACAFTOR 100 mg/1, IVACAFTOR 125 mg/1 51167-900 Vertex Pharmaceuticals Incorporated ORKAMBI GRANULE · LUMACAFTOR 150 mg/1, IVACAFTOR 188 mg/1 51167-500 Vertex Pharmaceuticals Incorporated

Country

Products

US 5

ORKAMBI
TABLET, FILM COATED · LUMACAFTOR 100 mg/1, IVACAFTOR 125 mg/1
51167-700
Vertex Pharmaceuticals Incorporated
ORKAMBI
TABLET, FILM COATED · LUMACAFTOR 200 mg/1, IVACAFTOR 125 mg/1
51167-809
Vertex Pharmaceuticals Incorporated
ORKAMBI
GRANULE · LUMACAFTOR 75 mg/1, IVACAFTOR 94 mg/1
51167-122
Vertex Pharmaceuticals Incorporated
ORKAMBI
GRANULE · LUMACAFTOR 100 mg/1, IVACAFTOR 125 mg/1
51167-900
Vertex Pharmaceuticals Incorporated
ORKAMBI
GRANULE · LUMACAFTOR 150 mg/1, IVACAFTOR 188 mg/1
51167-500
Vertex Pharmaceuticals Incorporated

Registration

Sources