EMEA-002324-PIP01-17-M03 - paediatric investigation plan

elexacaftor

tezacaftor

ivacaftor

Key facts

• Invented name:
  • Kaftrio
  • Kaftrio
• Active Substance:
  • elexacaftor
  • tezacaftor
  • ivacaftor
• Therapeutic area:
  • Other
  • Pneumology-allergology
• Decision number:
  P/0265/2022
• PIP number:
  EMEA-002324-PIP01-17-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of cystic fibrosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Vertex Pharmaceuticals (Ireland) Limited

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/07/2022

Decision

P/0265/2022: EMA decision of 22 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for elexacaftor / tezacaftor/ ivacaftor (Kaftrio), (EMEA-002324-PIP01-17-M03)

Reference Number: EMA/624974/2022