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Lumacaftor / ivacaftor (re-assessment: cystic fibrosis; homozygous F508del mutation in CFTR gene; aged ≥ 2 - ≤ 5 years)

Subject:

  • Active Substance: Lumacaftor / ivacaftor
  • Name: Orkambi®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

  • Start: 01.10.2021
  • Final decision by G-BA: 18.03.2022

Final decision:

  • Hint for a non-quantifiable additional benefit