EMEA-000576-PIP03-12-M06 - paediatric investigation plan

tofacitinib

Key facts

• Invented name:
  Xeljanz
• Active substance:
  tofacitinib
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0439/2022
• PIP number:
  EMEA-000576-PIP03-12-M06
• 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:
  28/10/2022
• Compliance check done:
  Ei

Decision

P/0439/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (Xeljanz) (EMEA-000576-PIP03-12-M06)

Adopted Reference Number: EMA/808195/2022