EMEA-001619-PIP03-16-M02 - paediatric investigation plan

filgotinib

Key facts

• Active substance:
  filgotinib
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0526/2023
• PIP number:
  EMEA-001619-PIP03-16-M02
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of ulcerative colitis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023
• Compliance check done:
  Ne

Decision

P/0526/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for filgotinib (Jyseleca), (EMEA-001619-PIP03-16-M02)

Reference Number: EMA/561838/2023