EMEA-000311-PIP04-13-M04 - paediatric investigation plan

Ustekinumab

Key facts

• Invented name:
  Stelara
• Active Substance:
  Ustekinumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0401/2022
• PIP number:
  EMEA-000311-PIP04-13-M04
• 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
• Contact for public enquiries:

  Janssen Cilag International NV

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022

Decision

P/0401/2022 : EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara), (EMEA-000311-PIP04-13-M05)

AdoptedReference Number: EMA/709431/2022