Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: SERB SAS, 40 Avenue George V, 75008 Paris, France
Voraxaze 1,000 units powder for solution for injection.
| Pharmaceutical Form |
|---|
|
White to off-white powder for solution for injection. |
After reconstitution with 1 mL of sterile 0.9% sodium chloride solution, each vial contains a nominal 1,000 units of glucarpidase*.
* Produced in Escherichia coli cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Glucarpidase |
Glucarpidase is a recombinant bacterial enzyme that hydrolyses the carboxyl-terminal glutamate residue from folic acid and structurally related molecules such asMTX. Glucarpidase converts MTX to its inactive metabolites DAMPA and glutamate. |
| List of Excipients |
|---|
|
Lactose |
3 mL type 1 glass vials (Ph Eur) with a bromobutyl stopper and standard blue flip off seal.
Pack size of 1 vial.
SERB SAS, 40 Avenue George V, 75008 Paris, France
EU/1/21/1586/001
| Drug | Countries | |
|---|---|---|
| VORAXAZE | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United States |
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