Orkambi 100 mg / 125 mg film-coated tablets

Licence status
Authorised: 08/01/2018
Active substances
Lumacaftor, Ivacaftor
Dosage Form
Film-coated tablet
Licence number
EU/1/15/1059/005
Licence holder
Vertex Pharmaceuticals (Ireland) Limited

Product documents

Licence information

ATC code
R07AX Other respiratory system products, R07AX30 ivacaftor and lumacaftor.
Legal supply status
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Conditions of Licence
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing availability
Unknown
Advertising conditions
Advertising to healthcare professionals only
Licence issued
08/01/2018