EMEA-000428-PIP01-08-M03 - paediatric investigation plan

turoctocog alpha

Key facts

• Invented name:
  • NovoEight
  • NovoEight
• Active substance:
  turoctocog alpha
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0207/2016
• PIP number:
  EMEA-000428-PIP01-08-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:
  12/08/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000428-PIP01-08-M03
• Compliance opinion date:
  26/04/2019
• Compliance outcome:
  Positive

Decision

P/0207/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for turoctocog alfa (NovoEight) (EMEA-000428-PIP01-08-M03)

Adopted Reference Number: EMA/441051/2016