EMEA-002565-PIP02-19-M01 - paediatric investigation plan

Difelikefalin

Key facts

• Active substance:
  Difelikefalin
• Therapeutic area:
  Other
• Decision number:
  P/0058/2024
• PIP number:
  EMEA-002565-PIP02-19-M01
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of chronic kidney disease associated pruritus
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/03/2024
• Compliance check done:
  No

Decision

P/0058/2024 : EMA decision of 7 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for difelikefalin (Kapruvia), (EMEA-002565-PIP02-19-M01)

Adopted Reference Number: EMA/81537/2024