Gazyvaro: Withdrawal of the application to change the marketing authorisation
obinutuzumab
Table of contents
Overview
Roche Registration GmbH withdrew its application for the use of Gazyvaro as a pre-treatment to reduce the risk of cytokine release syndrome (CRS) associated with Columvi (glofitamab), a cancer medicine used to treat adults with a blood cancer called diffuse large B-cell lymphoma (DLBCL).
The company withdrew the application on 4 July 2023.
Key facts
Name |
Gazyvaro |
Product number |
EMEA/H/C/002799 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
22/07/2014 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
04/07/2023 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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Withdrawal assessment report for Gazyvaro (PDF/9.51 MB)
First published: 04/10/2023
EMA/CHMP/371337/2023 -
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Withdrawal letter: Gazyvaro (PDF/8.95 KB)
First published: 21/07/2023 -
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Questions and answers on the withdrawal of application to change the marketing authorisation for Gazyvaro (obinutuzumab) (PDF/118.56 KB)
First published: 21/07/2023
Last updated: 04/10/2023
EMEA/328985/2023 -
Related information on withdrawals
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