Preferred Label : Balversa;
Origin ID : M000648585;
Related record
- Validated automatic mappings to NTBT
https://www.ema.europa.eu/en/medicines/human/EPAR/balversa
2025
false
false
false
Netherlands
French
English
syndication feed
summary of product characteristics
package leaflet
drug evaluation
treatment outcome
erdafitinib
erdafitinib
erdafitinib
drug approval
europe
Balversa
Metastatic Urothelial Carcinoma
Unresectable Urothelial Carcinoma
urologic neoplasms
adult
urologic neoplasms
FGFR3 Gene Alteration Positive
administration, oral
continuity of patient care
Tyrosine Kinase Inhibitors
Tyrosine Kinase Inhibitors
FGFR Inhibitor
FGFR Inhibitor
risk management
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
Female of Childbearing Potential
antineoplastic agents
antineoplastic agents
drug evaluation, preclinical
---
https://www.has-sante.fr/jcms/p_3585759/fr/balversa-erdafitinib-carcinome-urothelial
2025
false
false
false
France
treatment outcome
insurance, health, reimbursement
erdafitinib
Product containing only erdafitinib in oral dose form (medicinal product form)
administration, oral
FGFR Inhibitor
receptors, fibroblast growth factor
adult
Unresectable Urothelial Carcinoma
Metastatic Urothelial Carcinoma
FGFR3 Gene Alteration Positive
receptor, fibroblast growth factor, type 3
Alteration of genetic material (finding)
evaluation of the transparency committee
Balversa
erdafitinib
---
