EMEA-000311-PIP03-11-M06 - paediatric investigation plan

Ustekinumab

Key facts

• Invented name:
  • Stelara
  • Stelara
• Active Substance:
  Ustekinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0467/2020
• PIP number:
  EMEA-000311-PIP03-11-M06
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for injection (in pre-filled syringe)
  • 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
• Contact for public enquiries:

  Janssen-Cilag International NV

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2020

Decision

P/0467/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara) (EMEA-000311-PIP03-11-M06)

AdoptedReference Number: EMA/576874/2020