EMEA-003550-PIP01-23 - paediatric investigation plan

humanized IgG4 Monoclonal Antibody against FIXa and FX (NXT007)

Key facts

• Active substance:
  humanized IgG4 Monoclonal Antibody against FIXa and FX (NXT007)
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0403/2024
• PIP number:
  EMEA-003550-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Haemophilia A
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/01/2025
• Compliance check done:
  Ne

Decision

P/0403/2024 : EMA decision of 15 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral for humanized IgG4 Monoclonal Antibody against FIXa and FX (NXT007), (EMEA-003550-PIP01-23)

Adopted Reference Number: EMA/16279/2025