EMEA-001523-PIP04-19-M02 - paediatric investigation plan

Guselkumab

Key facts

• Invented name:
  Tremfya
• Active substance:
  Guselkumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0190/2023
• PIP number:
  EMEA-001523-PIP04-19-M02
• Pharmaceutical form(s):
  • Solution for injection in pre-filled pen
  • Solution for injection in pre-filled syringe
• 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:
  15/05/2023
• Compliance check done:
  Nem

Decision

P/0190/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP04-19-M02)

Adopted Reference Number: EMA/201814/2023