MHRA-101244-PIP01-23-M01 (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-101244-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Prolonged-release tablet
  • Oral solution
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of vitiligo
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
17/08/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101244-PIP01-23-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):UPADACITINIB.pdf
Published Date 14/10/2026