EMEA-000753-PIP02-16 - paediatric investigation plan

susoctocog alfa

Key facts

• Invented name:
  • Obizur
  • Obizur
• Active substance:
  susoctocog alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  EMEA-000753-PIP02-16
• PIP number:
  EMEA-000753-PIP02-16
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of congenital haemophilia A with antibodies (inhibitors) to human factor VIII
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/12/2017
• Compliance check done:
  No

Decision

P/0381/2017: EMA decision of 19 December 2017 on the agreement of a paediatric investigation plan and on the granting of a waiver for susoctocog alfa (Obizur), (EMEA-000753-PIP02-16)

Adopted Reference Number: EMA/759392/2017