EMEA-002324-PIP01-17-M05 - paediatric investigation plan

elexacaftor

tezacaftor

ivacaftor

Key facts

• Invented name:
  Kaftrio
• Active substance:
  • elexacaftor
  • tezacaftor
  • ivacaftor
• Therapeutic area:
  Other
• Decision number:
  P/0392/2023
• PIP number:
  EMEA-002324-PIP01-17-M05
• 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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/09/2023
• Compliance check done:
  No

Decision

P/0392/2023 : EMA decision of 28 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for elexacaftor / tezacaftor/ ivacaftor (Kaftrio), (EMEA-002324-PIP01-17-M05)

Reference Number: EMA/400386/2023