EMA/PE/0000232302 - paediatric investigation plan

filgotinib maleate

Key facts

• Invented name:
  Jyseleca
• Active substance:
  filgotinib maleate
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  EMA/PE/0000232302
• PIP number:
  EMA/PE/0000232302
• 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:
  16/04/2025
• Compliance check done:
  Nem

Decision

EMA/PE/0000232302 : EMA decision of 16 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for filgotinib maleate (Jyseleca)

Adopted Reference Number: EMADOC-1700519818-2020998