EMA/PE/0000225490 - paediatric investigation plan

emapalumab

Key facts

• Active substance:
  emapalumab
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMA/PE/0000225490
• PIP number:
  EMA/PE/0000225490
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of haemophagocytic lymphohistiocytosis
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/07/2025
• Compliance check done:
  Όχι

Decision

EMA/PE/0000225490: EMA decision of 11 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for emapalumab

Adopted Reference Number: EMADOC-1700519818-2221842