Kalydeco 13.4 mg granules in sachet
- Licence status
- Active substances
- Ivacaftor
- Dosage Form
- Granules
- Licence number
- EU/1/12/782/010-011
- 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
- 25/04/2024