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Kaftrio 75 mg / 50 mg / 100 mg granules in sachet

Licence status
Authorised: 22/11/2023
Active substances
Elexacaftor, TEZACAFTOR, Ivacaftor
Dosage Form
Granules in sachet
Licence number
EU/1/20/1468/004
Licence holder
Vertex Pharmaceuticals (Ireland) Limited

Licence information

ATC code
R07AX32 ivacaftor, tezacaftor and elexacaftor
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
22/11/2023