EMEA-000311-PIP06-18 - paediatric investigation plan

ustekinumab

Key facts

• Invented name:
  Stelara
• Active substance:
  ustekinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0178/2019
• PIP number:
  EMEA-000311-PIP06-18
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/05/2019
• Compliance check done:
  Ne

Decision

P/0178/2019: EMA decision of 15 May 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ustekinumab (Stelara), (EMEA-000311-PIP06-18)

Adopted Reference Number: EMA/227159/2019