Symkevi (tezacaftor;ivacaftor)
- Region
- 🇪🇺 EU
- Active substance
- tezacaftor;ivacaftor
- Company
- Vertex Pharmaceuticals (Ireland) Limited
- Status
- Authorised
- Therapeutic area
- Cystic Fibrosis
- CHMP opinion
- Wed 27 Jun 2018
- EU approval
- Wed 31 Oct 2018
- Designations
- Orphan
- Application
- EMEA/H/C/004682
- ATC
- R07AX31
- Official record
- www.ema.europa.eu
Indication
Symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (CF) aged 6 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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.