MHRA-101447-PIP01-24-M02 (update)

Key Facts

Active Substance
Active Substance:
  • DIFELIKEFALIN ACETATE
Invented Name
  • Kapruvia
  • Kapruvia
PIP Number MHRA-101447-PIP01-24-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection/infusion
Therapeutic area
Therapeutic area:
  • Other: Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic kidney disease associated pruritus.
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DIFELIKEFALIN ACETATE.pdf
Published Date 29/08/2025