Tecentriq

RSS

atezolizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 03/09/2018

Authorisation details

Product details
Name
Tecentriq
Agency product number
EMEA/H/C/004143
Active substance
atezolizumab
International non-proprietary name (INN) or common name
atezolizumab
Therapeutic area (MeSH)
  • Carcinoma, Transitional Cell
  • Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01XC
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
21/09/2017
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

09/08/2018 Tecentriq - EMEA/H/C/004143 - N/0015

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic indication

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.

Assessment history

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