EMEA-003385-PIP01-22 - paediatric investigation plan

axatilimab

Key facts

• Active substance:
  axatilimab
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMEA-003385-PIP01-22
• PIP number:
  EMEA-003385-PIP01-22
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of chronic Graft versus Host Disease (cGvHD)
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/04/2025
• Compliance check done:
  Nein

Decision

EMEA-003385-PIP01-22: EMA decision of 15 April 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for axatilimab

Adopted Reference Number: EMADOC-1700519818-2038993