Imbruvica: Withdrawal of the application to change the marketing authorisation



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

Product number
Date of issue of market authorisation valid throughout the European Union (if applicable)
International non-proprietary name (INN) or common name
  • ibrutinib
Active substance
  • Ibrutinib
Date of withdrawal
Company making the application
Janssen-Cilag International NV
Withdrawal type

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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