ONDEXXYA

This brand name is authorized in Austria, Canada, Croatia, Estonia, Finland, France, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, UK.

Active ingredients

The drug ONDEXXYA contains one active pharmaceutical ingredient (API):

1	Andexanet alfa UNII BI009E452R - ANDEXANET ALFA
	Andexanet alfa is a recombinant form of human FXa protein that has been modified to lack FXa enzymatic activity. Andexanet alfa is a specific reversal agent for FXa inhibitors. The predominant mechanism of action is the binding and sequestration of the FXa inhibitor. In addition, andexanet alfa has been observed to bind to, and inhibit tissue factor pathway inhibitor (TFPI). Inhibition of TFPI activity can increase tissue factor-initiated thrombin generation inducing a pro-coagulant effect.
	Read more about Andexanet alfa

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ONDEXXYA Powder for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
V03AB38		V Various → V03 All other therapeutic products → V03A All other therapeutic products → V03AB Antidotes
Discover more medicines within V03AB38

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
CA	Health Products and Food Branch	02538539
EE	Ravimiamet	1794135
FI	Lääkealan turvallisuus- ja kehittämiskeskus	517621
FR	Base de données publique des médicaments	68434099
GB	Medicines & Healthcare Products Regulatory Agency	373477
IT	Agenzia del Farmaco	047822010
JP	医薬品医療機器総合機構	3399414D1022
LT	Valstybinė vaistų kontrolės tarnyba	1087664
NL	Z-Index G-Standaard, PRK	198528
PL	Rejestru Produktów Leczniczych	100420093
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W68889001