MHRA-101767-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • TOFACITINIB CITRATE
Invented Name
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
PIP Number MHRA-101767-PIP01-24-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet Prolonged-release film-coated tablet Age-appropriate oral liquid formulation Prolonged-release age-appropriate oral formulation
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis).
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TOFACITINIB CITRATE.pdf
Published Date 08/04/2025