EMEA-001741-PIP09-23 - paediatric investigation plan

upadacitinib

Key facts

• Invented name:
  Rinvoq
• Active Substance:
  upadacitinib
• Therapeutic area:
  Dermatology
• Decision number:
  P/0451/2023
• PIP number:
  EMEA-001741-PIP09-23
• Pharmaceutical form(s):
  • Age-appropriate oral dosage form
  • Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/10/2023

Decision

P/0451/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for upadacitinib (Rinvoq), (EMEA-001741-PIP09-23)

AdoptedReference Number: EMA/481596/2023