PADCEV

This brand name is authorized in Canada, Estonia, France, Croatia, Israel, Italy, Japan, Lithuania, Poland, United Kingdom, United States

Active ingredients

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

1 Enfortumab vedotin UNII DLE8519RWM - ENFORTUMAB VEDOTIN

Enfortumab vedotin is an antibody drug conjugate (ADC) targeting Nectin-4, an adhesion protein located on the surface of the urothelial cancer cells. It is comprised of a fully human IgG1-kappa antibody conjugated to the microtubule-disrupting agent MMAE via a protease-cleavable maleimidocaproyl valine-citrulline linker. Nonclinical data suggest that the anticancer activity of enfortumab vedotin is due to the binding of the ADC to Nectin-4-expressing cells, followed by internalisation of the ADC-Nectin-4 complex, and the release of MMAE via proteolytic cleavage. Read about Enfortumab vedotin

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
PADCEV Powder for solution for infusion	European Medicines Agency (EU)	MPI, EU: SmPC
PADCEV EJFV Powder for 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
L01FX13	Enfortumab vedotin	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FX Other monoclonal antibodies
Discover more medicines within L01FX13

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 02521903, 02521911
Country: EE	Ravimiamet	Identifier(s): 1880748, 1880759
Country: FR	Base de données publique des médicaments	Identifier(s): 67032044, 67688034
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8782, 8783
Country: IT	Agenzia del Farmaco	Identifier(s): 050008010, 050008022
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291459D1020, 42914E0D2026
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1094618, 1094619
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100469050, 100469068
Country: US	FDA, National Drug Code	Identifier(s): 51144-020, 51144-030