VYLOY

This brand name is authorized in United States. It is also authorized in Austria, Estonia, Finland, France, Italy, Lithuania, Romania, UK.

Active ingredients

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

1	Zolbetuximab UNII TF5MPQ8WGY - ZOLBETUXIMAB
	Zolbetuximab is a chimeric (mouse/human IgG1) monoclonal antibody directed against the tight junction molecule CLDN18.2. Nonclinical data suggest zolbetuximab binds selectively to cell lines transfected with CLDN18.2 or those that endogenously express CLDN18.2. Zolbetuximab depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
	Read more about Zolbetuximab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
VYLOY Powder for concentrate for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

ATC Group		Classification
L01FX31		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FX Other monoclonal antibodies
Discover more medicines within L01FX31

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
EE	Ravimiamet	3090260, 3090271
FI	Lääkealan turvallisuus- ja kehittämiskeskus	491818
FR	Base de données publique des médicaments	62607473
IT	Agenzia del Farmaco	051605018, 051605020
LT	Valstybinė vaistų kontrolės tarnyba	1101286, 1101287
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W70873001, W70873002
US	FDA, National Drug Code	0469-3425