EMA/PE/0000236669 - paediatric investigation plan

ritlecitinib

Key facts

• Active substance:
  ritlecitinib
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0289/2023
• PIP number:
  EMA/PE/0000236669
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral solid dosage form
  • Tablet
• Condition(s) / indication(s):
  Treatment of vitiligo
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000236669 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ritlecitinib (Litfulo)

Adopted Reference Number: EMADOC-1700519818-2039163