EMEA-000576-PIP01-09-M16 - paediatric investigation plan

Tofacitinib

Key facts

• Invented name:
  Xeljanz
• Active Substance:
  Tofacitinib
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0239/2024
• PIP number:
  EMEA-000576-PIP01-09-M16
• 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:
  18/07/2024

Decision

P/0239/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (Xeljanz), (EMEA-000576-PIP01-09-M16)

AdoptedReference Number: EMA/319201/2024