EMA/PE/0000257243 - paediatric investigation plan

pozelimab

Key facts

• Active substance:
  pozelimab
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000257243
• PIP number:
  EMA/PE/0000257243
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/08/2025
• Compliance check done:
  No

Decision

EMA/PE/0000257243 : EMA decision of 4 August 2025 on the acceptance of a modification of an agreed paediatric investigation plan for pozelimab

Adopted Reference Number: EMADOC-1700519818-2320688