MHRA-100086-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • UPADACITINIB
Invented Name
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
PIP Number MHRA-100086-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Prolonged release tablet
  • Prolonged release capsule, hard
  • Age-appropriate oral solid dosage form
  • Age-appropriate oral liquid dosage form
Therapeutic area
  • Immunology -Rheumatology-Transplantation
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • treatment of atopic dermatitis
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 03/10/2024