EMEA-001484-PIP01-13-M01 - paediatric investigation plan

Elobixibat

Key facts

• Active substance:
  Elobixibat
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0218/2016
• PIP number:
  EMEA-001484-PIP01-13-M01
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate dosage form, other
• Condition(s) / indication(s):
  Treatment of chronic constipation
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/08/2016
• Compliance check done:
  No

Decision

P/0218/2016: EMA decision of 15 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for elobixibat (EMEA- 001484-PIP01-13-M01)

Adopted Reference Number: EMA/501683/2016