An overview of Tecentriq and why it is authorised in the EU
Tecentriq is a cancer medicine for treating urothelial carcinoma (a cancer of the bladder and urinary system) and a type of lung cancer called non‑small cell lung cancer.
Tecentriq is used when these cancers are advanced or have spread to other parts of the body. For urothelial carcinoma, the medicine is for patients who have tried platinum chemotherapy before or are ineligible for treatment with cisplatin. Patients with non‑small cell lung cancer should first have had chemotherapy and those with certain genetic mutations (changes) that respond to targeted treatments should have those treatments before receiving Tecentriq.
Tecentriq contains the active substance atezolizumab.
Tecentriq : EPAR - Summary for the public (PDF/76.65 KB)
First published: 29/09/2017
Last updated: 13/04/2018
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Roche Registration GmbH
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09/08/2018 Tecentriq - EMEA/H/C/004143 - N/0015
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) after prior platinum-containing chemotherapy or who are considered cisplatin ineligible.
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving Tecentriq.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 201816/11/2018