Balversa
Balversa ingredients
| Active ingredient | Strength |
|---|---|
| Erdafitinib | 4 mg/1, 5 mg/1, 3 mg/1 |
What Balversa is used for
The FDA lists the approved uses on the official label (below). In the EU, erdafitinib is approved as Balversa for:
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).
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Balversa
- Generic name
- Erdafitinib
- Made by
- Janssen Products LP
- Forms
- Tablet, Film Coated
- Given
- Oral
- Drug class
- Kinase Inhibitor
- FDA approval
- New drug application (NDA) NDA212018
- On the US market since
- 2019
Official information
- Balversa prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Erdafitinib)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Balversa?
Balversa (Erdafitinib) is a cancer medicine made by Janssen Products LP, approved by the US FDA.
What are the ingredients of Balversa?
Balversa contains Erdafitinib (4 mg/1, 5 mg/1, 3 mg/1).
Is Balversa approved in Europe?
The same active substance is approved in the EU as Balversa.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA