EMEA-002769-PIP01-20 - paediatric investigation plan

human fibrinogen

Key facts

• Active substance:
  human fibrinogen
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0260/2020
• PIP number:
  EMEA-002769-PIP01-20
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of congenital fibrinogen deficiency
• 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:
  15/07/2020
• Compliance check done:
  No

Decision

P/0260/2020: EMA decision of 15 July 2020 on the refusal of a paediatric investigation plan and on the granting of a waiver for human fibrinogen (EMEA-002769-PIP01-20)

Adopted Reference Number: EMA/366114/2020