AVASTIN Concentrate for solution for infusion (2018)
Active ingredients: Bevacizumab
Product Name and Form
Avastin 25 mg/ml concentrate for solution for infusion.
Concentrate for solution for infusion.
Clear to slightly opalescent, colourless to pale brown liquid.
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.
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.
Water for injections
Pack sizes and Marketing
- 4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
- 16 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 mg of bevacizumab.
Pack of 1 vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Date of first authorisation: 12 January 2005
Date of latest renewal: 14 January 2015
EU/1/04/300/001 – 100 mg/4 ml vial
EU/1/04/300/002 – 400 mg/16 ml vial