EMA/PE/0000226657 - paediatric investigation plan

abelacimab

Key facts

• Active substance:
  abelacimab
• Therapeutic area:
  Vascular disorders
• Decision number:
  EMA/PE/0000226657
• PIP number:
  EMA/PE/0000226657
• Pharmaceutical form(s):
  • Concentrate for solution for injection
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Prevention of thromboembolic events
  • Treatment of thromboembolic events
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000226657 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for abelacimab

Adopted Reference Number: EMADOC-1700519818-1840316