BALVERSA
As listed in the register: BALVERSA
4 mg · tablet
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Erdafitinib
- Made by
- Janssen Inc
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (BALVERSA). It describes the substance, not this exact product.
Erdafitinib is a kinase inhibitor that binds to and inhibits enzymatic activity of FGFR1, FGFR2, FGFR3 and FGFR4 based on in vitro data.
Erdafitinib inhibited FGFR phosphorylation and signaling and decreased cell viability in cell lines expressing FGFR genetic alterations, including point mutations, amplifications, and fusions.
Erdafitinib is primarily metabolized by CYP2C9 and CYP3A4.
Effect of Food No clinically meaningful differences in erdafitinib exposure was observed following administration of BALVERSA with a high-fat and high-calorie meal (800 calories to 1,000 calories with approximately 50% of total caloric content of the meal from fat).
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-24
Safety of the active substance
From the US prescribing label for the same active substance (BALVERSA). It describes the substance, not this exact product.
The most frequent (>3%) serious adverse reactions were central serous retinopathy (4.6%), urinary tract infection (3.4%), and general physical health deterioration (3.4%).
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
Spain1 matching products
Netherlands1 matching products
SwitzerlandNo exact match for this strength and form
Details
| Made by | Janssen Inc |
|---|---|
| Active substance | Erdafitinib |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 4 mg |
| Form | tablet |
| Classification | L01EN01 · Cancer treatments and immune-system medicines |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Approved |
| Marketed | No — authorised but not currently marketed, according to the register |
| DIN | 02493241 |
| DPD drug code | 98323 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Other strengths and forms
4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- tablet4 products
- 3 mg
4 mg2
4 mg · 2 companies
- Janssen Inc · this page
- Janssen Inc
- 5 mg
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.