EMEA-000335-PIP01-08-M15 - paediatric investigation plan

ivacaftor

Key facts

• Invented name:
  Kalydeco
• Active substance:
  ivacaftor
• Therapeutic area:
  Other
• Decision number:
  P/0002/2023
• PIP number:
  EMEA-000335-PIP01-08-M15
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules in sachet
• 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:
  06/01/2023
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000335-PIP01-08-M15
• Compliance opinion date:
  20/01/2023
• Compliance outcome:
  Positive

Decision

P/0002/2023 : EMA decision of 6 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor (Kalydeco), (EMEA-000335-PIP01-08-M15)

Reference Number: EMA/1721/2023