Orkambi
- Licence status
- 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.
- Route of supply
- 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
Stay updated: document advice
The information and documents on this page are subject to frequent updates. We recommend you do not retain saved or printed versions of them. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie