EMEA-000645-PIP04-20-M02 - paediatric investigation plan

vedolizumab

Key facts

• Invented name:
  Entyvio
• Active substance:
  vedolizumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0382/2023
• PIP number:
  EMEA-000645-PIP04-20-M02
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of pouchitis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/09/2023
• Compliance check done:
  Ne

Decision

P/0382/2023 : EMA decision of 7 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for vedolizumab (Entyvio) (EMEA-000645-PIP04-20-M02)

Adopted Reference Number: EMA/389683/2023