EMEA-003321-PIP01-22 - paediatric investigation plan

ciraparantag

Key facts

• Active substance:
  ciraparantag
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0421/2023
• PIP number:
  EMEA-003321-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Prevention of FXa inhibitor-associated haemorrhage
  • Treatment of FXa inhibitor-associated haemorrhage
• 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:
  27/10/2023
• Compliance check done:
  No

Decision

P/0421/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for ciraparantag (EMEA-003321-PIP01-22)

Adopted Reference Number: EMA/429548/2023