EMEA-001064-PIP01-10-M03 - paediatric investigation plan

octocog alfa

Key facts

• Invented name:
  • • Iblias
    • Kovaltry
  • • Iblias
    • Kovaltry
• Active substance:
  octocog alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0060/2018
• PIP number:
  EMEA-001064-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:
  16/03/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001064-PIP01-10-M03
• Compliance opinion date:
  23/07/2021
• Compliance outcome:
  Positive

Decision

P/0060/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for octocog alfa (Iblias, Kovaltry) (EMEA-001064-PIP01-10-M03)

Adopted Reference Number: EMA/102305/2018