EMEA-001220-PIP01-11-M09 - paediatric investigation plan

Baricitinib

Key facts

• Invented name:
  Olumiant
• Active Substance:
  Baricitinib
• Therapeutic area:
  Immune system disorders
• Decision number:
  P/0520/2023
• PIP number:
  EMEA-001220-PIP01-11-M09
• Pharmaceutical form(s):
  • Oral suspension
  • 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:
  29/12/2023

Decision

P/0520/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib (Olumiant), (EMEA-001220-PIP01-11-M09)

Reference Number: EMA/561779/2023