EMEA-001203-PIP02-14-M02 - paediatric investigation plan

Coagulation Factor VIIa (Recombinant)

Key facts

• Active substance:
  Coagulation Factor VIIa (Recombinant)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0214/2017
• PIP number:
  EMEA-001203-PIP02-14-M02
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  • Treatment of acquired haemophilia
  • Treatment of congenital coagulation disorders
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/08/2017
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001203-PIP02-14-M02
• Compliance opinion date:
  04/09/2020
• Compliance outcome:
  Positive

Decision

P/0214/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for coagulation Factor VIIa (Recombinant) (EMEA-001203-PIP02-14-M02)

Adopted Reference Number: EMA/461645/2017