VOXZOGO Powder and solvent for solution for injection Ref.[49897] Active ingredients: Vosoritide

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

Product name and form

Voxzogo 0.4 mg powder and solvent for solution for injection.

Voxzogo 0.56 mg powder and solvent for solution for injection.

Voxzogo 1.2 mg powder and solvent for solution for injection.

Pharmaceutical Form

Powder and solvent for solution for injection.

The powder is white to yellow and the solvent is clear and colourless.

Qualitative and quantitative composition

Voxzogo 0.4 mg powder and solvent for solution for injection: Each vial of powder contains 0.4 mg of vosoritide*. After reconstitution, each vial contains 0.4 mg vosoritide in 0.5 mL of solution, corresponding to a concentration of 0.8 mg/mL.

Voxzogo 0.56 mg powder and solvent for solution for injection: Each vial of powder contains 0.56 mg of vosoritide*. After reconstitution, each vial contains 0.56 mg vosoritide in 0.7 mL of solution, corresponding to a concentration of 0.8 mg/mL.

Voxzogo 1.2 mg powder and solvent for solution for injection: Each vial of powder contains 1.2 mg of vosoritide*. After reconstitution, each vial contains 1.2 mg vosoritide in 0.6 mL of solution, corresponding to a concentration of 2 mg/mL.

* produced in Escherichia coli cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Vosoritide

Vosoritide is a modified type C natriuretic peptide (CNP). In patients with achondroplasia, endochondral bone growth is negatively regulated due to a gain of function mutation in fibroblast growth factor receptor 3 (FGFR3). Binding of vosoritide to natriuretic peptide receptor-B (NPR-B) antagonises FGFR3 downstream signalling. As a result, vosoritide, like CNP, acts as a positive regulator of endochondral bone growth as it promotes chondrocyte proliferation and differentiation.

List of Excipients

Powder:

Citric acid (E330)
Sodium citrate (E331)
Trehalose dihydrate
Mannitol (E421)
Methionine
Polysorbate 80 (E433)

Solvent:

Water for injections

Pack sizes and marketing

Vosoritide 0.4 mg powder and solvent for solution for injection

Powder: 2 mL vial (glass) with rubber stopper (bromobutyl) and white flip cap.

Solvent: Pre-filled syringe (glass) with plunger (bromobutyl) and tip cap with a luer lock and tamper evident seal containing 0.5 mL of water for injections.

Vosoritide 0.56 mg powder and solvent for solution for injection

Powder: 2 mL vial (glass) with rubber stopper (bromobutyl) and magenta flip cap.

Solvent: Pre-filled syringe (glass) with plungers (bromobutyl) and tip cap with a luer lock and tamper evident seal containing 0.7 mL of water for injections.

Vosoritide 1.2 mg powder and solvent for solution for injection

Powder: 2 mL vial (glass) with rubber stopper (bromobutyl) and grey flip cap.

Solvent: Pre-filled syringe (glass) with plungers (bromobutyl) and tip cap with a luer lock and tamper evident seal containing 0.6 mL of water for injections

Each carton contains:

  • 10 vials of Voxzogo
  • 10 pre-filled syringes of water for injections
  • 10 individual single use needles (23 gauge, for reconstitution)
  • 10 individual single use syringes (30 gauge, for administration)

Marketing authorization holder

BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

Drugs

Drug Countries
VOXZOGO Estonia, Ireland, Japan, Lithuania, Poland, Romania

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