EMEA-000311-PIP04-13-M06 - paediatric investigation plan

ustekinumab

Key facts

• Invented name:
  Stelara
• Active substance:
  ustekinumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0341/2023
• PIP number:
  EMEA-000311-PIP04-13-M06
• Pharmaceutical form(s):
  • Solution for injection/infusion
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Crohn's disease
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2023
• Compliance check done:
  Nein

Decision

P/0341/2023: EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara), (EMEA-000311-PIP04-13-M06)

Reference Number: EMA/351971/2023