Imbruvica: Withdrawal of the application to change the marketing authorisation
ibrutinib
Table of contents
Overview
Janssen-Cilag International N.V. withdrew its application for the use of Imbruvica in combination with bendamustine and rituximab for patients with previously untreated mantle cell lymphoma (MCL, a cancer of a type of white blood cell called B cells).
The company withdrew the application on 13 December 2022.
Key facts
Name |
Imbruvica |
Product number |
EMEA/H/C/003791 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
21/10/2014 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
13/12/2022 |
Company making the application | |
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 202327/01/2023
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24/06/2022
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29/10/2021
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03/09/2021
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24/07/2020
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28/06/2019
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22/07/2016
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29/04/2016
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22/05/2015
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22/05/2015
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25/07/2014
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25/07/2014