This brand name is authorized in Austria, Canada, Estonia, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom
The drug ONDEXXYA contains one active pharmaceutical ingredient (API):
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1
Andexanet alfa
UNII BI009E452R - ANDEXANET ALFA
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| ONDEXXYA Powder for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| V03AB38 | V Various → V03 All other therapeutic products → V03A All other therapeutic products → V03AB Antidotes | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: CA | Health Products and Food Branch | Identifier(s): 02538539 |
| Country: EE | Ravimiamet | Identifier(s): 1794135 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 517621 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 68434099 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 373477 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 047822010 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 3399414D1022 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1087664 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 198528 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100420093 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W68889001 |
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