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AVASTIN Concentrate for solution for infusion (2018)

Active ingredients: Bevacizumab

Product Name and Form

Avastin 25 mg/ml concentrate for solution for infusion.

Pharmaceutical form

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.

Chemical substance
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
Sodium phosphate
Polysorbate 20
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.

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

EU/1/04/300/001 – 100 mg/4 ml vial
EU/1/04/300/002 – 400 mg/16 ml vial