EMA/PE/0000184081 - paediatric investigation plan

etrasimod

Key facts

• Invented name:
  Velsipity
• Active substance:
  etrasimod
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  EMA/PE/0000184081
• PIP number:
  EMA/PE/0000184081
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of ulcerative colitis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000184081 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for etrasimod (Velsipity)

Adopted Reference Number: EMADOC-1700519818-1798766