Gazyvaro: Withdrawal of the application to change the marketing authorisation

obinutuzumab

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.

  • List item

    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

  • 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
    • obinutuzumab
    Active substance
    • Obinutuzumab
    Date of withdrawal
    04/07/2023
    Company making the application
    Roche Registration GmbH
    Withdrawal type
    Post-authorisation

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