PADCEV

This brand name is authorized in United States. It is also authorized in Canada, Croatia, Estonia, France, Israel, Italy, Japan, Lithuania, Poland, UK.

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 more about Enfortumab vedotin

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
PADCEV EJFV Powder for solution for injection	MPI, US: SPL/PLR	FDA, National Drug Code (US)
PADCEV Powder 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
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)
CA	Health Products and Food Branch	02521903, 02521911
EE	Ravimiamet	1880748, 1880759
FR	Base de données publique des médicaments	67032044, 67688034
IL	מִשְׂרַד הַבְּרִיאוּת	8782, 8783
IT	Agenzia del Farmaco	050008010, 050008022
JP	医薬品医療機器総合機構	4291459D1020, 42914E0D2026
LT	Valstybinė vaistų kontrolės tarnyba	1094618, 1094619
PL	Rejestru Produktów Leczniczych	100469050, 100469068
US	FDA, National Drug Code	51144-020, 51144-030