EMEA-001619-PIP04-17-M02 - paediatric investigation plan

filgotinib

Key facts

• Invented name:
  Jyseleca
• Active Substance:
  filgotinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0113/2023
• PIP number:
  EMEA-001619-PIP04-17-M02
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2023

Decision

P/0113/2023 : EMA decision of 13 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for filgotinib (Jyseleca), (EMEA-001619-PIP04-17-M02)

Reference Number: EMA/103716/2023