Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
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 |
|---|
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Powder and solvent for solution for injection. The powder is white to yellow and the solvent is clear and colourless. |
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 by inhibiting the extracellular signal-regulated kinases 1 and 2 (ERK1/2) in the mitogen-activated protein kinase (MAPK) pathway at the level of rapidly accelerating fibrosarcoma serine/threonine protein kinase (RAF-1). 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) Solvent: Water for injections |
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.
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.
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:
BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
EU/1/21/1577/001 10 × 0.4 mg Powder and solvent for solution for injection
EU/1/21/1577/002 10 × 0.56 mg Powder and solvent for solution for injection
EU/1/21/1577/003 10 × 1.2 mg Powder and solvent for solution for injection
Date of first authorisation: 26 August 2021
| Drug | Countries | |
|---|---|---|
| VOXZOGO | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, Romania |
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