EMEA-001902-PIP01-15-M04 - paediatric investigation plan

andexanet alfa

Key facts

• Invented name:
  Ondexxya
• Active substance:
  andexanet alfa
• Therapeutic area:
  Other
• Decision number:
  P/0349/2020
• PIP number:
  EMEA-001902-PIP01-15-M04
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  • Prevention of factor Xa inhibitor associated haemorrhage
  • Treatment of factor Xa inhibitor associated haemorrhage
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2020
• Compliance check done:
  Nie

Decision

P/0349/2020 : EMA decision of 9 September 2020 on the acceptance of a modification of an agreed paediatric investigation plan for andexanet alfa (Ondexxya) (EMEA-001902-PIP01-15-M04)

Adopted Reference Number: EMA/415148/2020