Prognia
Drug Database
🇪🇺EU · EMAAuthorisedATC: L01EN01

Balversa(Erdafitinib)

Urologic Neoplasms

Marketing Authorisation Holder: Janssen-Cilag International N.V.

EMA Authorisation: 22/08/2024

INN: erdafitinib

Indication

Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (see section 5.1).

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.