Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 04 July 2019

Indication(s)

Symkevi is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/004682
Orphan designation Yes
Date First Approved 31-10-2018
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Vertex Pharmaceuticals (Ireland) Limited