MHRA-102031-PIP01-25

Key Facts

Active Substance
Active Substance:
  • resmetirom
Invented Name
  • Rezdiffra
  • Rezdiffra
PIP Number MHRA-102031-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film coated tablet Age appropriate oral dosage form
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of metabolic dysfunction-associated steatohepatitis
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
21/11/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-102031-PIP01-25-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):resmetirom.pdf
Published Date 08/01/2026