BALVERSA

This brand name is authorized in Canada, Hong Kong, Israel, Turkey, United States

Active ingredients

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

1 Erdafitinib UNII 890E37NHMV - ERDAFITINIB

Erdafitinib is a kinase inhibitor that binds to and inhibits enzymatic activity of FGFR1, FGFR2, FGFR3 and FGFR4 based on in vitro data. Erdafitinib also binds to RET, CSF1R, PDGFRA, PDGFRB, FLT4, KIT, and VEGFR2. Erdafitinib demonstrated antitumor activity in FGFR-expressing cell lines and xenograft models derived from tumor types, including bladder cancer.

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
BALVERSA Film-coated tablet	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
L01EN01	Erdafitinib	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EN Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
Discover more medicines within L01EN01

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): 02493217, 02493225, 02493233
Country: HK	Department of Health Drug Office	Identifier(s): 66726, 66727, 66728
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8488, 8489, 8490, 8491, 8492
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699593095627, 8699593095634, 8699593095641, 8699593095658, 8699593095665
Country: US	FDA, National Drug Code	Identifier(s): 59676-030, 59676-040, 59676-050