🇪🇺 Ivacaftor+lumacaftor in European Union

EMA authorised Ivacaftor+lumacaftor on 19 November 2015

Marketing authorisation

EMA — authorised 19 November 2015

  • Application: EMEA/H/C/003954
  • Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
  • Local brand name: Orkambi
  • Indication: Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene. Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.
  • Status: approved

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Ivacaftor+lumacaftor in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Ivacaftor+lumacaftor approved in European Union?

Yes. EMA authorised it on 19 November 2015.

Who is the marketing authorisation holder for Ivacaftor+lumacaftor in European Union?

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