EMEA-001523-PIP03-18-M03 - paediatric investigation plan

Guselkumab

Key facts

• Invented name:
  Tremfya
• Active substance:
  Guselkumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0384/2023
• PIP number:
  EMEA-001523-PIP03-18-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/09/2023
• Compliance check done:
  Ei

Decision

P/0384/2023: EMA decision of 7 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP03-18-M03)

Reference Number: EMA/389483/2023