EMEA-001619-PIP04-17-M03 - paediatric investigation plan

filgotinib

Key facts

• Invented name:
  Jyseleca
• Active substance:
  filgotinib
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0119/2024
• PIP number:
  EMEA-001619-PIP04-17-M03
• 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:
  12/04/2024
• Compliance check done:
  No

Decision

P/0119/2024: EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for filgotinib (Jyseleca), (EMEA-001619-PIP04-17-M03)

Adopted Reference Number: EMA/114605/2024