EMEA-001741-PIP10-23 - paediatric investigation plan

upadacitinib

Key facts

• Invented name:
  Rinvoq
• Active substance:
  upadacitinib
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0062/2024
• PIP number:
  EMEA-001741-PIP10-23
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of alopecia areata
• 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:
  08/03/2024
• Compliance check done:
  Ne

Decision

P/0062/2024 : EMA decision of 8 March 2024 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-PIP10-23)

Adopted Reference Number: EMA/87189/2024