EMEA-000311-PIP05-17-M02 - paediatric investigation plan

ustekinumab

Key facts

• Invented name:
  • Stelara
  • Stelara
• Active substance:
  ustekinumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0281/2020
• PIP number:
  EMEA-000311-PIP05-17-M02
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection/infusion
• 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:
  19/03/2021
• Compliance check done:
  Nej

Decision

P/0084/2021 : EMA decision of 19 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara) (EMEA-000311-PIP05-17-M02)

Adopted Reference Number: EMA/72931/2021