Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Tecentriq 840 mg concentrate for solution for infusion.
Tecentriq 1 200 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear, colourless to slightly yellowish liquid. The solution has a pH of 5.5-6.1 and an osmolality of 129-229 mOsm/kg. |
Tecentriq 840 mg concentrate for solution for infusion: One 14 mL vial of concentrate contains 840 mg of atezolizumab*.
Tecentriq 1 200 mg concentrate for solution for infusion: One 20 mL vial of concentrate contains 1 200 mg atezolizumab*.
After dilution (see section 6.6), the final concentration of the diluted solution should be between 3.2 and 16.8 mg/mL.
* 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 |
Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic grey or aqua flip-off cap containing 14 mL or 20 mL of concentrate solution for infusion.
Pack of one vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/17/1220/001
EU/1/17/1220/002
Date of first authorisation: 21 September 2017
Date of latest renewal: 25 April 2022
| Drug | Countries | |
|---|---|---|
| TECENTRIQ | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States |
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