New indication for Kalydeco
Kalydeco (ivacaftor; Vertex) is now indicated for the treatment of patients with cystic fibrosis aged 18 years or older who have a R117H mutation in the CFTR gene. Further changes to the summary of product characteristics (SPC) reflect this addition. Additionally, the SPC has revised dosage information to reflect a new sachet presentation of the product.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200549
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