Kalydeco 50 mg granules in sachet

Licence status
Authorised: 16/11/2015
Active substances
Ivacaftor
Dosage Form
Granules in sachet
Licence number
EU/1/12/782/003
Licence holder
Vertex Pharmaceuticals (Ireland) Limited

Product documents

Licence information

ATC code
R07AX02 ivacaftor
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
16/11/2015