MHRA-100093-PIP01-21-M05 (update)

Key Facts

Active Substance
Active Substance:
  • UPADACITINIB
Invented Name
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
PIP Number MHRA-100093-PIP01-21-M05 (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
Yes
Compliance Check Decision Date
Compliance opinion date
07/04/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100093-PIP01-21-M05-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):UPADACITINIB.pdf
Published Date 14/04/2026