EMEA-002485-PIP01-18-M01 - paediatric investigation plan

Norursodeoxycholic acid

Key facts

• Active substance:
  Norursodeoxycholic acid
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0360/2023
• PIP number:
  EMEA-002485-PIP01-18-M01
• Pharmaceutical form(s):
  • Capsule
  • Age appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  • Treatment of autoimmune sclerosing cholangitis
  • Treatment of primary sclerosing cholangitis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0360/2023: EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for norucholic acid (EMEA-002485-PIP01-18-M01)

Adopted Reference Number: EMA/347454/2023