EMA/PE/0000249046 - paediatric investigation plan

Guselkumab

Key facts

• Invented name:
  Tremfya
• Active substance:
  Guselkumab
• Therapeutic area:
  • Gastrointestinal disorders
  • Gastroentology-Hepatology
• Decision number:
  EMA/PE/0000249046
• PIP number:
  EMA/PE/0000249046
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of Crohn's disease
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/07/2025
• Compliance check done:
  Nie

Decision

EMA/PE/0000249046 : EMA decision of 10 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya)

Adopted Reference Number: EMADOC-1700519818-2259085