GAZYVA

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

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 more about Obinutuzumab

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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