Cholic acid - paediatric investigation plan

cholic acid

Key facts

• Active substance:
  cholic acid
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/206/2011
• PIP number:
  Cholic acid
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  • Treatment of other inborn errors of bile acid synthesis
  • Treatment of oxysterol 7a-hydrolylase deficiency and defective amida
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/08/2011
• Compliance check done:
  No

Decision

P/206/2011: EMA decision of 31 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for cholic acid, (EMEA- 000651-PIP01-09-M02)

Adopted Reference Number: EMA/688412/2011