EMEA-001523-PIP05-19-M01 - paediatric investigation plan

Guselkumab

Key facts

• Invented name:
  Tremfya
• Active Substance:
  Guselkumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0065/2022
• PIP number:
  EMEA-001523-PIP05-19-M01
• Pharmaceutical form(s):
  • Solution for injection in pre-filled pen
  • Solution for injection in pre-filled syringe
  • 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:
  11/03/2022

Decision

P/0065/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP05-19-M01)

AdoptedReference Number: EMA/68373/2022