Gazyvaro - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn.

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.

Questions and answers on the withdrawal of application to change the marketing authorisation for Gazyvaro (obinutuzumab)

Reference Number: EMEA/328985/2023

Key facts

• Name of medicine:
  Gazyvaro
• EMA product number:
  EMEA/H/C/002799
• Active substance:
  Obinutuzumab
• International non-proprietary name (INN) or common name:
  obinutuzumab
• Therapeutic area (MeSH):
  Leukemia, Lymphocytic, Chronic, B-Cell
• Anatomical therapeutical chemical (ATC) code:
  L01XC15
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Roche Registration GmbH
• Date of issue of marketing authorisation valid throughout the European Union:
  22/07/2014
• Date of withdrawal:
  04/07/2023

Documents

Withdrawal letter: Gazyvaro (II-0052)

Adopted

Withdrawal assessment report for Gazyvaro

Reference Number: EMA/CHMP/371337/2023