OYAVAS Concentrate for solution for infusion Ref.[27639] Active ingredients: Bevacizumab

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Product name and form

Oyavas 25 mg/mL concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).

Colourless to yellowish or brownish liquid with opalescence.

Qualitative and quantitative composition

Each mL of concentrate contains 25 mg of bevacizumab*.

Each 4 mL vial contains 100 mg of bevacizumab.

Each 16 mL vial contains 400 mg of bevacizumab.

For dilution and other handling recommendations, see section 6.6.

* Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.

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

Trehalose dihydrate
Monobasic sodium phosphate monohydrate
Disodium phosphate
Polysorbate 20
Water for injections

Pack sizes and marketing

4 mL solution in a vial (Type I glass) with a stopper (chlorobutyl rubber) containing 100 mg of bevacizumab.

16 mL solution in a vial (Type I glass) with a stopper (chlorobutyl rubber) containing 400 mg of bevacizumab.

Pack of 1 vial.

Marketing authorization holder

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Marketing authorization dates and numbers

EU/1/20/1510/001 – 100 mg/4 mL
EU/1/20/1510/002 – 400 mg/16 mL

Drugs

Drug Countries
OYAVAS Austria, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom

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