EMA/PE/0000237641 - paediatric investigation plan

Difelikefalin

Key facts

• Invented name:
  Kapruvia
• Active substance:
  Difelikefalin
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  EMA/PE/0000237641
• PIP number:
  EMA/PE/0000237641
• 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:
  16/05/2025
• Compliance check done:
  Nem

Decision

EMA/PE/0000237641 : EMA decision of 16 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for difelikefalin (Kapruvia)

Adopted Reference Number: EMADOC-1700519818-2113203