MHRA-100991-PIP01-23

Key Facts

Active Substance
Active Substance:
  • Maralixibat chloride
Invented Name
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
PIP Number MHRA-100991-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral solution
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of progressive familial intrahepatic cholestasis (PFIC)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
03/11/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100991-PIP01-23-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MARALIXIBAT CHLORIDE.pdf
Published Date 30/01/2024