LYTENAVA Solution for injection Ref.[110288] Active ingredients: Bevacizumab

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Outlook Therapeutics Limited, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

Product name and form

Lytenava 25 mg/mL solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Colourless to slightly brown solution with a pH of 6.1 and an osmolality of 235–315 mOsm/kg.

Qualitative and quantitative composition

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
Disodium hydrogen phosphate
α,α-Trehalose dihydrate
Polysorbate 20 (E432)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Outlook Therapeutics Limited, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

Marketing authorization dates and numbers

EU/1/24/1798/001

Drugs

Drug Countries
LYTENAVA Lithuania

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