MHRA-102401-PIP01-26-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ANDEXANET ALFA
Invented Name
  • Ondexxya
  • Andexxa
  • Ondexxya
  • Ondexxya
  • Andexxa
  • Andexxa
  • Ondexxya
  • Andexxa
  • Ondexxya
  • Andexxa
  • Ondexxya
  • Ondexxya
PIP Number MHRA-102401-PIP01-26-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for infusion
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
  • Treatment of factor Xa inhibitor associated haemorrhage
  • Prevention of factor Xa inhibitor associated haemorrhage
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ANDEXANET ALFA.pdf
Published Date 06/07/2026