EMEA-001304-PIP02-13-M07 - paediatric investigation plan

Obeticholic acid

Key facts

• Invented name:
  Ocaliva
• Active Substance:
  Obeticholic acid
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0287/2023
• PIP number:
  EMEA-001304-PIP02-13-M07
• Pharmaceutical form(s):
  • Coated tablet
  • Tablet
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  • Treatment of biliary atresia
  • Treatment of primary biliary cirrhosis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/08/2023

Decision

P/0287/2023 : EMA decision of 4 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for obeticholic acid (Ocaliva), (EMEA-001304-PIP02-13-M07)

Reference Number: EMA/338823/2023