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Ivacaftor (new indication: cystic fibrosis; in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 6 - ≤ 11 years (heterozygous for F508del and MF mutation))

Subject:

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

Time table:

  • Start: 15.02.2022
  • Final decision by G-BA: 04.08.2022

Final decision:

  • Indication for a considerable additional benefit