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Gazyvaro (obinutuzumab)

Region

🇪🇺 EU

Active substance

obinutuzumab

Company

Roche Registration GmbH

Status

Authorised

Therapeutic area

Leukemia, Lymphocytic, Chronic, B-Cell

CHMP opinion

Wed 21 May 2014

EU approval

Tue 22 Jul 2014

Application

EMEA/H/C/002799

ATC

L01FA03

Official record

www.ema.europa.eu

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.  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.  Lupus nephritis (LN) Gazyvaro in combination with mycophenolate mofetil (MMF) is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN). 

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.