Table of contents
Gazyvaro is a cancer medicine used to treat adults with:
- previously untreated chronic lymphocytic leukaemia (CLL). CLL is a cancer of B-lymphocytes, a type of white blood cell. Gazyvaro is used together with chlorambucil (another cancer medicine) in patients for whom the cancer medicine fludarabine is not recommended;
- follicular lymphoma (FL), another type of cancer of B-lymphocytes. Gazyvaro is used together with chemotherapy (other cancer medicines) in patients who have not had previous treatment for advanced FL. It is also used with the medicine bendamustine in patients whose disease has not responded to treatment involving the medicine rituximab or whose cancer has progressed within 6 months after such treatment. Once the disease has responded to treatment, Gazyvaro is then used on its own for the maintenance treatment of FL.
Gazyvaro contains the active substance obinutuzumab.
These diseases are rare, and Gazyvaro was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency’s website (CLL:10 October 2012; FL: 19 June 2015).
Gazyvaro : EPAR - Summary for the public (PDF/139.13 KB)
First published: 20/08/2014
Last updated: 19/05/2020
Gazyvaro : EPAR - Risk-management-plan summary (PDF/104.28 KB)
First published: 20/08/2014
Last updated: 27/10/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Leukemia, Lymphocytic, Chronic, B-Cell
|Anatomical therapeutic chemical (ATC) code||
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.
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.
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
01/09/2022 Gazyvaro - EMEA/H/C/002799 - II/0051
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Chronic Lymphocytic Leukaemia (CLL)
Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).
Follicular Lymphoma (FL)
Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.
Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 201410/07/2014