VORAXAZE Powder for solution for injection Ref.[28329] Active ingredients: Glucarpidase

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: SERB SAS, 40 Avenue George V, 75008 Paris, France

Product name and form

Voraxaze 1,000 units powder for solution for injection.

Pharmaceutical Form

White to off-white powder for solution for injection.

Qualitative and quantitative composition

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
Trometamol
Zinc acetate dihydrate

Pack sizes and marketing

3 mL type 1 glass vials (Ph Eur) with a bromobutyl stopper and standard blue flip off seal.

Pack size of 1 vial.

Marketing authorization holder

SERB SAS, 40 Avenue George V, 75008 Paris, France

Marketing authorization dates and numbers

EU/1/21/1586/001

Drugs

Drug Countries
VORAXAZE Estonia, Ireland, Poland, Romania, United States

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