🇪🇺 TEZ in European Union

EMA authorised TEZ on 31 October 2018

Marketing authorisation

EMA — authorised 31 October 2018

  • Application: EMEA/H/C/004682
  • Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
  • Local brand name: Symkevi
  • 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.
  • Pathway: orphan
  • Status: approved

Read official source →

Frequently asked questions

Is TEZ approved in European Union?

Yes. EMA authorised it on 31 October 2018.

Who is the marketing authorisation holder for TEZ in European Union?

Vertex Pharmaceuticals (Ireland) Limited holds the EU marketing authorisation.