EMEA-000576-PIP01-09-M15 - paediatric investigation plan

Tofacitinib

Key facts

• Invented name:
  Xeljanz
• Active Substance:
  Tofacitinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0308/2023
• PIP number:
  EMEA-000576-PIP01-09-M15
• Pharmaceutical form(s):
  • Film-coated tablet
  • Prolonged-release film-coated tablet
  • Oral solution
  • Prolonged-release age-appropriate oral formulation
  • Age-appropriate oral liquid 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:
  07/08/2023

Decision

P/0308/2023 : EMA decision of 7 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (Xeljanz), (EMEA-000576-PIP01-09-M15)

Reference Number: EMA/344151/2023