EMA/PE/0000226763 - paediatric investigation plan

tofacitinib citrate

Key facts

• Invented name:
  Xeljanz
• Active substance:
  tofacitinib citrate
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  EMA/PE/0000226763
• PIP number:
  EMA/PE/0000226763
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral solution
• 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:
  14/04/2025
• Compliance check done:
  No