Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Outlook Therapeutics Limited, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
Lytenava 25 mg/mL solution for injection.
| Pharmaceutical Form |
|---|
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Solution for injection (injection). Colourless to slightly brown solution with a pH of 6.1 and an osmolality of 235–315 mOsm/kg. |
Each mL of solution contains 25 mg bevacizumab gamma*.
Each vial contains 7.5 mg of bevacizumab gamma in 0.3 mL solution. This provides a usable amount to deliver a single dose of 0.05 mL containing 1.25 mg bevacizumab gamma.
* Bevacizumab gamma is a humanised monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Bevacizumab |
Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells. Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate monohydrate |
Lytenava 25 mg/mL solution for injection contains 0.3 mL solution in a 2 mL vial (Type 1 glass) with a stopper (butyl rubber) containing 7.5 mg of bevacizumab gamma.
Pack size of 1 vial.
Outlook Therapeutics Limited, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
EU/1/24/1798/001
| Drug | Countries | |
|---|---|---|
| LYTENAVA | Lithuania |
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