TECENTRIQ Concentrate for solution for infusion (2019)
Active ingredients: Atezolizumab
Product Name and Form
Tecentriq 1,200 mg concentrate for solution for infusion.
Concentrate for solution for infusion.
Clear, colourless to slightly yellowish liquid.
Qualitative and Quantitative Composition
Each 20 mL vial of concentrate contains 1,200 mg atezolizumab*.
After dilution (see section 6.6), one mL of solution contains approximately 4.4 mg of atezolizumab.
* Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed death-ligand 1 (PD-L1) monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
Atezolizumab is an Fc-engineered, humanised immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and provides a dual blockade of the PD-1 and B7.1 receptors, releasing PD-L1/PD-1 mediated inhibition of the immune response, including reactivating the antitumour immune response without inducing antibody-dependent cellular cytotoxicity.
Glacial acetic acid
Water for injections
Pack sizes and Marketing
Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic aqua flip-off cap containing 20 mL of concentrate solution for infusion.
Pack of one vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Date of first authorisation: 21 September 2017