Orkambi 150 mg / 188 mg granules in sachet

Licence status
Authorised: 15/01/2019
Active substances
Ivacaftor, Lumacaftor
Dosage Form
Granules in sachet
Licence number
EU/1/15/1059/007
Licence holder
Vertex Pharmaceuticals (Ireland) Limited

Product documents

Licence information

ATC code
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
15/01/2019