Gazyvaro

RSS

obinutuzumab

Authorised
This medicine is authorised for use in the European Union.

Overview

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).

This EPAR was last updated on 19/05/2020

Authorisation details

Product details
Name
Gazyvaro
Agency 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 therapeutic chemical (ATC) code
L01XC15
Additional monitoringAdditional 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.

OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
22/07/2014
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

17/04/2020 Gazyvaro - EMEA/H/C/002799 - II/0038

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

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