Arzerra: Withdrawal of the application to change the marketing authorisation
ofatumumab
Table of contents
Overview
On 8 November 2016, Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Arzerra to be used in a new combination with bendamustine for the treatment of relapsed chronic lymphocytic leukaemia (CLL).
Key facts
Name |
Arzerra |
Product number |
EMEA/H/C/001131 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
19/04/2010 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
08/11/2016 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal letter: Arzerra (PDF/519.75 KB)
First published: 16/12/2016
Last updated: 16/12/2016 -
List item
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Arzerra (ofatumumab) (PDF/82.14 KB)
First published: 16/12/2016
Last updated: 16/12/2016
EMA/847130/2016 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').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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16/12/2016
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 201611/11/2016
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24/06/2016
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23/05/2014