SPC: TECENTRIQ Concentrate for solution for infusion (2019)

Product Name and Form

Tecentriq 1,200 mg concentrate for solution for infusion.

Pharmaceutical form

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.

List of excipients

L-histidine
Glacial acetic acid
Sucrose
Polysorbate 20
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.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 21 September 2017

Marketing authorization number:

EU/1/17/1220/001