Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Gazyvaro   
Auth. number : EU/1/14/937
Active substance : obinutuzumab
Orphan market exclusivity for "Treatment of chronic lymphocytic leukaemia" (based on designation EU/3/12/1054) started on 24/07/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 24/07/2024
Orphan market exclusivity for "Treatment of follicular lymphoma" (based on designation EU/3/15/1504) started on 15/06/2016
   10 years of market exclusivity
   This orphan market exclusivity will expire on 15/06/2026
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC15 - Obinutuzumab
(See WHO ATC Index)
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 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.
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
24/07/2014 Centralised - Authorisation EMEA/H/C/2799 (2014)5379 of 23/07/2014
21/05/2015 Centralised - Variation EMEA/H/C/2799/II/3
Updated with Decision(2016)3167 of 20/05/2016
01/04/2016 Centralised - Variation EMEA/H/C/2799/II/9
Updated with Decision(2016)3167 of 20/05/2016
24/05/2016 Centralised - Yearly update (2016)3167 of 20/05/2016
15/06/2016 Centralised - 2-Monthly update EMEA/H/C/2799/II/7 (2016)3744 of 13/06/2016
09/12/2016 Corrigendum
20/09/2017 Centralised - Variation EMEA/H/C/2799/II/16 (2017)6426 of 18/09/2017
26/10/2017 Centralised - Variation EMEA/H/C/2799/II/20