EMEA-002713-PIP02-21-M02 - paediatric investigation plan

etrasimod

Key facts

• Invented name:
  Velsipity
• Active substance:
  etrasimod
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0321/2024
• PIP number:
  EMEA-002713-PIP02-21-M02
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of Crohn's disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0321/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for etrasimod (Velsipity), (EMEA-002713-PIP02-21-M02)

Reference Number: EMA/411537/2024