Tecentriq: Withdrawal of the application to change the marketing authorisation

atezolizumab

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)
21/09/2017
International non-proprietary name (INN) or common name
  • atezolizumab
Active substance
  • atezolizumab
Date of withdrawal
22/10/2018
Company making the application
Roche Registration GmbH
Withdrawal type
Post-authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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