EMEA-002451-PIP01-18-M02 - paediatric investigation plan

ritlecitinib

Key facts

• Invented name:
  Litfulo
• Active substance:
  ritlecitinib
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0026/2024
• PIP number:
  EMEA-002451-PIP01-18-M02
• Pharmaceutical form(s):
  • Tablet
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of alopecia areata
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  26/01/2024
• Compliance check done:
  Ei

Decision

P/0026/2024 : EMA decision of 26 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ritlecitinib (Litfulo), (EMEA-002451-PIP01-18-M02)

Adopted Reference Number: EMA/553390/2023