EMEA-003017-PIP01-21 - paediatric investigation plan

abelacimab

Key facts

• Active substance:
  abelacimab
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0127/2022
• PIP number:
  EMEA-003017-PIP01-21
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  • Prevention of thromboembolic events
  • Treatment of thromboembolic events
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/04/2022
• Compliance check done:
  No

Decision

P/0127/2022 : EMA decision of 13 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for abelacimab (EMEA-003017-PIP01-21)

Adopted Reference Number: EMA/194423/2022