Pharmaceuticals - Community Register


Community register of medicinal products for human use


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
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC15 - Obinutuzumab
(See WHO ATC Index)
Indication: 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
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
01/04/2016 Centralised - Variation EMEA/H/C/2799/II/9