GAZYVA

This brand name is authorized in Australia, Brazil, Canada, Ecuador, Hong Kong, Israel, Japan, New Zealand, Singapore, Turkey, United States

Active ingredients

The drug GAZYVA contains one active pharmaceutical ingredient (API):

1 Obinutuzumab UNII O43472U9X8 - OBINUTUZUMAB

Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype. It specifically targets the extracellular loop of the CD20 transmembrane antigen on the surface of non-malignant and malignant pre-B and mature B-lymphocytes. Glycoengineering of the Fc part of obinutuzumab results in higher affinity for FcγRIII receptors on immune effector cells such as natural killer cells, macrophages and monocytes as compared to non-glycoengineered antibodies. Read about Obinutuzumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
GAZYVA Solution for injection	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L01FA03	Obinutuzumab	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FA CD20 (Clusters of Differentiation 20) inhibitors
Discover more medicines within L01FA03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10407R, 10418H, 11455X, 11456Y, 11457B, 11458C, 11460E, 11462G, 11468N, 11473W, 12193R, 12204H
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 529215070026102
Country: CA	Health Products and Food Branch	Identifier(s): 02434806
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 90-MBE-0317
Country: HK	Department of Health Drug Office	Identifier(s): 64100
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7586
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291444A1028
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 16147
Country: SG	Health Sciences Authority	Identifier(s): 14827P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699505762630
Country: US	FDA, National Drug Code	Identifier(s): 50242-070