EMEA-000731-PIP01-09-M03 - paediatric investigation plan

nonacog beta pegol

Key facts

• Invented name:
  Refixia
• Active substance:
  nonacog beta pegol
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0139/2019
• PIP number:
  EMEA-000731-PIP01-09-M03
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of hereditary factor IX deficiency
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/04/2019
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000731-PIP01-09-M03
• Compliance opinion date:
  15/11/2019
• Compliance outcome:
  Positive

Decision

P/0139/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for nonacog beta pegol (Refixia), (EMEA-000731-PIP01-09-M03)

Adopted Reference Number: EMA/216038/2019