EMEA-001114-PIP01-10-M03 - paediatric investigation plan

efmoroctocog alfa

Key facts

• Invented name:
  Elocta
• Active substance:
  efmoroctocog alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0149/2016
• PIP number:
  EMEA-001114-PIP01-10-M03
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of hereditary factor-VIII deficiency
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2016
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001114-PIP01-10-M03
• Compliance opinion date:
  29/05/2019
• Compliance outcome:
  Positive

Decision

P/0149/2016: EMA decision of 14 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for efmorocotocog alfa (Elocta), (EMEA-001114-PIP01-10-M03)

Adopted Reference Number: EMA/334432/2016