MHRA-101151-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • OBETICHOLIC ACID
Invented Name
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
PIP Number MHRA-101151-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Coated tablet
  • Tablet
  • Age-appropriate oral solid dosage form
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
  • Treatment of primary biliary cirrhosis
  • Treatment of biliary atresia
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
25/10/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101151-PIP01-23-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):OBETICHOLIC ACID.pdf
Published Date 16/07/2026