EMA/PE/0000232680 - paediatric investigation plan

ustekinumab

Key facts

• Invented name:
  Stelara
• Active substance:
  ustekinumab
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0084/2021
• PIP number:
  EMA/PE/0000232680
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of ulcerative colitis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/03/2025
• Compliance check done:
  No

Decision

EMA/PE/0000232680: EMA decision of 21 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara)

Adopted Reference Number: EMADOC-1700519818-1976512