EMEA-003313-PIP02-23 - paediatric investigation plan

povorcitinib

Key facts

• Active substance:
  povorcitinib
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  EMEA-003313-PIP02-23
• PIP number:
  EMEA-003313-PIP02-23
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral dosage formulation
• Condition(s) / indication(s):
  Treatment of non-segmental vitiligo
• 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:
  12/06/2025
• Compliance check done:
  Ne

Decision

EMEA-003313-PIP02-23 : EMA decision of 12 June 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for povorcitinib

Adopted Reference Number: EMADOC-1700519818-2187649