EMEA-001579-PIP01-13-M06 - paediatric investigation plan

eluxadoline

Key facts

• Active substance:
  eluxadoline
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0078/2024
• PIP number:
  EMEA-001579-PIP01-13-M06
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of diarrhoea-predominant irritable bowel Syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2022
• Compliance check done:
  No

Decision

P/0078/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for eluxadoline (EMEA- 001579-PIP01-13-M06)

Adopted Reference Number: EMA/89818/2024