EMEA-001107-PIP01-10-M04 - paediatric investigation plan

albutrepenonacog alfa

Key facts

• Invented name:
  Idelvion
• Active substance:
  albutrepenonacog alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0031/2020
• PIP number:
  EMEA-001107-PIP01-10-M04
• Pharmaceutical form(s):
  • Powder and solvent for solution for infusion
  • 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:
  29/01/2020
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-001107-PIP01-10-M04
• Compliance opinion date:
  21/01/2022

Decision

P/0031/2020: EMA decision of 29 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for albutrepenonacog alfa (Idelvion), (EMEA-001107-PIP01-10-M04)

Adopted Reference Number: EMA/12071/2020