MHRA-100093-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • UPADACITINIB
Invented Name
Rinvoq
PIP Number MHRA-100093-PIP01-21-M03 (update)
Pharmaceutical form(s)
  • Age-appropriate oral solid dosage form
  • Age-appropriate oral liquid dosage form
  • Prolonged-release tablet
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis 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):UPADACITINIB.pdf
Published Date 19/12/2023