Obinutuzumab
Cd20 (Clusters Of Differentiation 20) Inhibitors
Sold as Gazyvaro · GAZYVA
- Drug class
- Cd20 (Clusters Of Differentiation 20) Inhibitors
- Availability
- See label
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 7
Overview
Obinutuzumab is an active pharmaceutical ingredient in the Cd20 (Clusters Of Differentiation 20) Inhibitors group (L01FA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 5 | April 17, 2026 |
| EU European Union | EMA | 1 | March 17, 2026 |
| CA Canada | Health Canada | 1 | February 19, 2026 |
GBUnited Kingdom· MHRA
5 products
Uses
1). 1) Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with 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).
How to take
EUEuropean Union· EMA
1 product
Uses
1). 1) Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with 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).
How to take
CACanada· Health Canada
1 product
How to take
). Hepatitis B Virus (HBV) Reactivation HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA (see 7 Warnings and Precautions: Hepatitis B Virus Reactivation).
Progressive Multifocal Leukoencephalopathy (PML) PML can occur in patients receiving GAZYVA. Put GAZYVA treatment on hold in case of PML suspicion, until the diagnosis can be clearly established. Discontinue GAZYVA therapy and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML (see 7 Warnings and Precautions: Progressive Multifocal Leukoencephalopathy).
Tumour Lysis Syndrome (TLS) Serious TLS, including acute renal failure, has been reported in patients receiving GAZYVA [see 7 Warnings and Precautions: Tumour Lysis Syndrome (TLS)]. Cardiovascular Serious cardiac events, including worsening of existing underlying cardiac disease and fatal cases, such as fatal myocardial infarctions, have been reported with GAZYVA therapy (see 7 Warnings and Precautions: Cardiovascular).
Drug interactions
Known interactions involving Obinutuzumab. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB000310856 · revised April 17, 2026
- [2]European Medicines Agency · EMEA/H/C/002799 · revised March 17, 2026
- [3]Health Canada (DPD) · 02434806 · revised February 19, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.