Medicine
Balversa 4 mg tablet
Balversa 4 mg tablet is a prescription medicine containing Erdafitinib for oral use, marketed by Janssen Products, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C…
Key facts
- Active ingredient (INN)
- Erdafitinib
- Brand
- Balversa
- Strength
- 4 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Janssen Products
- Manufacturer
- Janssen Products
- Origin register
- US FDA, United States
- Storage
- Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C to 30 °C (59 °F to 86 °F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EN01 Erdafitinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 April 2019
- Identifiers
- RxCUI 2123131, 2123137, 2123139 +3DailyMed set ID 2a8aa5c0-6c92-4566-8c45-e8f4d1fc20eeNDC 59676-040Application NDA212018
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 28 tablet, film coated in 1 bottle | 59676-040-28 | Janssen Products | 12 April 2019 |
| 1 bottle in 1 carton / 56 tablet, film coated in 1 bottle | 59676-040-56 | Janssen Products | 12 April 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Erdafitinib
Clinical summary
Erdafitinib is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Erdafitinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about ErdafitinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BALVERSA prescribing information (Janssen Products) · U.S. National Library of Medicine, DailyMed
- Balversa: European public assessment report (EPAR) · European Medicines Agency
Need Balversa 4 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.