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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):OBETICHOLIC ACID.pdf
Published Date 03/10/2024