EMEA-001304-PIP03-17 - paediatric investigation plan

obeticholic acid

Key facts

• Invented name:
  • Ocaliva
  • Ocaliva
• Active substance:
  obeticholic acid
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0104/2018
• PIP number:
  EMEA-001304-PIP03-17
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Tablet
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/04/2018
• Compliance check done:
  Ei

Decision

P/0104/2018: EMA decision of 11 April 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obeticholic acid (Ocaliva), (EMEA-001304-PIP03-17)

Adopted Reference Number: EMA/197888/2018