Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Ondexxya 200 mg powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for infusion. White to off-white lyophilized powder. |
Each vial contains 200 mg of andexanet alfa*.
After reconstitution, each mL of solution contains 10 mg of andexanet alfa.
* Andexanet alfa is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
Tris base |
Powder in a 20 mL vial (Type I glass) with a stopper (butyl rubber).
Pack size of four or five vials.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/18/1345/001 4 vials
EU/1/18/1345/002 5 vials
Date of first authorisation: 26 April 2019
Date of latest renewal: 24 April 2023
| Drug | Countries | |
|---|---|---|
| ONDEXXYA | Austria, Canada, Estonia, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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