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Ivacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 12 years (heterozygous for F508del and other or unknown mutation))

Subject:

  • Active Substance: Ivacaftor
  • Name: Kalydeco®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11.2021

Final decision:

  • No additional benefit proved