Drug name: Avastin ®
API type: Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies.
ATC code: L01X C07
General function: inhibits vascular endothelial growth factor A and is commonly used to treat various cancers, including colorectal, lung, breast, kidney, and glioblastomas
Short description: Bevacizumab is comprised of a tetramer of two heavy and two light chains with one N-glycosylation site per heavy chain.
Original license holder:
Marketing authorisation numbers: EU/1/04/300/001 - 002
Marketing authorisation holder: Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Name of the manufacturer of the biological active substance: Genentech, Inc.; 1 DNA Way; South San Francisco, CA; 94080-4990 USA
F. Hoffmann-La Roche Ltd; Grenzacherstrasse 124; CH-4070 Basel; Switzerland
Name and address of the manufacturer responsible for batch release: Roche Pharma AG; Emil-Barrell-Str. 1; D-79639 Grenzach-Wyhlen; Germany
Max shelf life: 24 months
Storage conditions: 2°C – 8°C
List of excipients: Trehalose dihydrate, Sodium phosphate, Polysorbate 20, Water for injections