AVASTIN Concentrate for solution for infusion

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.

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

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

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

Date of first authorisation: 12 January 2005
Date of latest renewal: 14 January 2015

Drugs

Drug
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