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Irish Medicines Database · HPRA register

Orkambi 200 mg/125 mg film-coated tablets

Authorisation EU/1/15/1059/001 · Vertex Pharmaceuticals (Ireland) Limited

← All medicines
Orkambi 200 mg/125 mg film-coated tablets
Licence EU/1/15/1059/001 · Unknown
Licence holder
Vertex Pharmaceuticals (Ireland) Limited (all products →)
Active substances
Lumacaftor, Ivacaftor
Dosage form
Film-coated tablet
Route of administration
Oral use
ATC codes
R07AX, R07AX30
First authorised
19/11/2015
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.