Tecentriq: Withdrawal of the application to change the marketing authorisation
atezolizumab
Table of contents
Overview
On 22 October 2018, Roche Registration GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Tecentriq to extend its use for treating kidney cancer.
Key facts
Name |
Tecentriq |
Product number |
EMEA/H/C/004143 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
20/09/2017 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
22/10/2018 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
-
List item
Withdrawal letter: Tecentriq (PDF/17.58 KB)
First published: 16/11/2018
Last updated: 19/11/2018 -
List item
Questions and answers on the withdrawal of application for a change to the marketing authorisation for Tecentriq (atezolizumab) (PDF/112.51 KB)
First published: 16/11/2018
EMA/798527/2018
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').
News
-
22/04/2022
-
23/07/2021
-
21/05/2021
-
26/03/2021
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 202129/01/2021
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 202011/12/2020
-
01/10/2020
-
18/09/2020
-
26/07/2019
-
28/06/2019
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
-
16/11/2018
-
01/06/2018
-
01/06/2018
-
21/07/2017