EMEA-001296-PIP01-12-M04 - paediatric investigation plan

rurioctocog alfa pegol

Key facts

• Invented name:
  Adynovi
• Active substance:
  rurioctocog alfa pegol
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0302/2021
• PIP number:
  EMEA-001296-PIP01-12-M04
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2021
• Compliance check done:
  Nu

Decision

P/0302/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for rurioctocog alfa pegol (ADYNOVI) (EMEA-001296-PIP01-12-M04)

Adopted Reference Number: EMA/427607/2021