EMEA-000311-PIP03-11-M07 - paediatric investigation plan

ustekinumab

Key facts

• Invented name:
  Stelara
• Active substance:
  ustekinumab
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0370/2024
• PIP number:
  EMEA-000311-PIP03-11-M07
• Pharmaceutical form(s):
  • Solution for injection
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0370/2024 : EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara), (EMEA-000311-PIP03-11-M07)

Adopted Reference Number: EMA/465525/2024