Zydelig: Withdrawal of the application to change the marketing authorisation

idelalisib

Overview

On 30 January 2018, Gilead Sciences International Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to use the cancer medicine Zydelig in combination with the cancer medicines rituximab and bendamustine for the treatment of chronic lymphocytic leukaemia (CLL).

Key facts

Name
Zydelig
Product number
EMEA/H/C/003843
Date of issue of market authorisation valid throughout the European Union (if applicable)
17/09/2014
International non-proprietary name (INN) or common name
  • idelalisib
Active substance
  • Idelalisib
Date of withdrawal
30/01/2018
Company making the application
Gilead Sciences Ireland UC
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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