TECENTRIQ Concentrate for solution for infusion Ref.[6321] Active ingredients: Atezolizumab

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

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.

Active Ingredient Description
Atezolizumab

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.

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

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

Marketing authorization dates and numbers

EU/1/17/1220/001

Date of first authorisation: 21 September 2017

Drugs

Drug Countries
TECENTRIQ Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States

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