EMEA-002451-PIP02-21 - paediatric investigation plan

ritlecitinib

Key facts

• Active substance:
  ritlecitinib
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0333/2022
• PIP number:
  EMEA-002451-PIP02-21
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Capsule, hard
  • Tablet
• Condition(s) / indication(s):
  Treatment of ulcerative colitis
• 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:
  10/08/2022
• Compliance check done:
  Ne

Decision

P/0333/2022 : EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ritlecitinib (EMEA-002451-PIP02-21)

Adopted Reference Number: EMA/673784/2022