EMEA-001582-PIP01-13-M10 - paediatric investigation plan

Lumacaftor

ivacaftor

Key facts

• Invented name:
  • Orkambi
  • Orkambi
• Active substance:
  • Lumacaftor
  • ivacaftor
• Therapeutic area:
  Other
• Decision number:
  P/0506/2020
• PIP number:
  EMEA-001582-PIP01-13-M10
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules
• 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:
  22/12/2020
• Compliance check done:
  Ne

Decision

P/0506/2020: EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for lumacaftor / ivacaftor (Orkambi), (EMEA-001582-PIP01-13-M10)

Adopted Reference Number: EMA/632918/2020