EMEA-001931-PIP01-16-M03 - paediatric investigation plan

human fibrinogen concentrate (BT524)

Key facts

• Active substance:
  human fibrinogen concentrate (BT524)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0484/2023
• PIP number:
  EMEA-001931-PIP01-16-M03
• Pharmaceutical form(s):
  Powder for solution for injection or infusion
• Condition(s) / indication(s):
  Treatment of congenital fibrinogen deficiency
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/11/2023
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001931-PIP01-16-M03
• Compliance opinion date:
  23/02/2024
• Compliance outcome:
  Positive

Decision

P/0484/2023: EMA decision of 30 November 2023 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen concentrate (BT524) (EMEA-001931-PIP01-16-M03)

Adopted Reference Number: EMA/494326/2023