MHRA-101378-PIP01-24

Key Facts

Active Substance
Active Substance:
  • UPADACITINIB
Invented Name
Rinvoq
PIP Number MHRA-101378-PIP01-24
Pharmaceutical form(s)
  • Prolonged-release tablet
  • Age-appropriate oral liquid dosage form
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of hidradenitis suppurativa
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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 03/10/2024