BALVERSA

This brand name is authorized in United States. It is also authorized in Austria, Canada, Estonia, Finland, France, Hong Kong SAR China, Israel, Italy, Lithuania, Romania, Turkey, UK.

Active ingredients

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

1
UNII 890E37NHMV - ERDAFITINIB
 

Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor. Erdafitinib increases serum phosphate concentration, a secondary effect of FGFR inhibition.

 
Read more about Erdafitinib

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 BALVERSA Film-coated tablet MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

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

ATC Group 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)
CA Health Products and Food Branch 02493217, 02493225, 02493233
EE Ravimiamet 3089112, 3089224, 3089235, 3089246, 3089257, 3089268, 3089279, 3089280, 3089358, 3089415, 3089448
FI Lääkealan turvallisuus- ja kehittämiskeskus 415130, 442428, 454312
FR Base de données publique des médicaments 60039171, 65760218, 66039107
HK Department of Health Drug Office 66726, 66727, 66728
IL מִשְׂרַד הַבְּרִיאוּת 8488, 8489, 8490, 8491, 8492
IT Agenzia del Farmaco 051462012, 051462024, 051462036, 051462048, 051462051, 051462063, 051462075, 051462087, 051462099, 051462101, 051462113
LT Valstybinė vaistų kontrolės tarnyba 1100941, 1100942, 1100943, 1100944, 1100945, 1100946, 1100947, 1100948, 1100949, 1100950, 1100951
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W70738001, W70738002, W70738003, W70738004, W70739001, W70739002, W70739003, W70739004, W70739005, W70740001, W70740002
TR İlaç ve Tıbbi Cihaz Kurumu 8699593095627, 8699593095634, 8699593095641, 8699593095658, 8699593095665
US FDA, National Drug Code 59676-030, 59676-040, 59676-050

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