Octocog alfa - paediatric investigation plan

octocog alfa

Key facts

• Invented name:
  • Advate
  • Advate
• Active substance:
  octocog alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/65/2010
• PIP number:
  Octocog alfa
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Haemophilia A (congenital Factor VIII deficiency)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/05/2010
• Compliance check done:
  No

Decision

P/65/2010: European Medicines Agency decision on the granting of a product specific waiver for octocog alfa (Advate) (EMEA-000358-PIP02-09)

Adopted Reference Number: EMA/236895/2010