EMA/PE/0000222532 - paediatric investigation plan

tofacitinib

Key facts

• Invented name:
  Xeljanz
• Active substance:
  tofacitinib
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  EMA/PE/0000222532
• PIP number:
  EMA/PE/0000222532
• Pharmaceutical form(s):
  • Film-coated tablet
  • Prolonged-release tablet
  • Prolonged-release age-appropriate oral formulation
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis 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:
  28/01/2025
• Compliance check done:
  Ei

Decision

EMA/PE/0000222532 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (Xeljanz)

Adopted Reference Number: EMADOC-1700519818-1840302