GAZYVARO

This brand name is authorized in Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Tunisia, United Kingdom

Active ingredients

The drug GAZYVARO 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
GAZYVARO Concentrate for solution for infusion	European Medicines Agency (EU)	MPI, EU: SmPC

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: EE	Ravimiamet	Identifier(s): 1657133
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 114937001, 114937001IP
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 439579
Country: FR	Base de données publique des médicaments	Identifier(s): 61042996
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 254445, 383727
Country: IT	Agenzia del Farmaco	Identifier(s): 043533013
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1073957
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 118478
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100325911
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64380001
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 6993231H