EMEA-001215-PIP01-11-M07 - paediatric investigation plan

lonoctocog alfa

Key facts

• Invented name:
  Afstyla
• Active substance:
  lonoctocog alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0329/2019
• PIP number:
  EMEA-001215-PIP01-11-M07
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/09/2019
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001215-PIP01-11-M07
• Compliance opinion date:
  10/09/2021
• Compliance outcome:
  Positive

Decision

P/0329/2019: EMA decision of 10 September 2019 on the acceptance of a modification of an agreed paediatric investigation plan for lonoctocog alfa (Afstyla) (EMEA-001215-PIP01-11-M07)

Adopted Reference Number: EMA/480337/2019