EMEA-000914-PIP01-10-M05 - paediatric investigation plan

eftrenonacog alfa

Key facts

• Invented name:
  Alprolix
• Active substance:
  eftrenonacog alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0071/2020
• PIP number:
  EMEA-000914-PIP01-10-M05
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of hereditary factor-IX deficiency
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/03/2020
• Compliance check done:
  Tak
• Compliance procedure number:
  EMEA-C-000914-PIP01-10-M05
• Compliance opinion date:
  24/07/2020
• Compliance outcome:
  Positive

Decision

P/0071/2020: EMA decision of 18 March 2020 on the acceptance of a modification of an agreed paediatric investigation plan for Eftrenonacog alfa (Alprolix) (EMEA-000914-PIP01-10-M05)

Adopted Reference Number: EMA/83075/2020