Sweden· SE-20230909000038
Balversa 5 mg Filmdragerad tablett
A medicinal product containing erdafitinib, registered in Sweden by Janssen-Cilag International NV.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Erdafitinib
- Manufacturer
- Janssen-Cilag International NV
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20230909000038
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Erdafitinib in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumBalversa 5 mgJanssen-Cilag International
- SwitzerlandBalversa
- CzechiaBALVERSAJanssen-Cilag International N.V., Beerse
- SpainBALVERSA 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULAJanssen-Cilag International N.V
- FinlandBalversaJanssen Cilag International
- FranceBALVERSA 5 mg, comprimé pelliculéJANSSEN CILAG INTERNATIONAL NV
- IrelandBalversa 5 mg Film-coated tabletJanssen-Cilag International NV
- IcelandBalversaJanssen-Cilag International NV*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Balversa
- Liechtenstein · Balversa
- Norway · Balversa
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of Swedish Medical Products Agency (Sweden). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/e0da6b23-6406-4c86-a080-9009fe11f5fb GET /v1/drugs/e0da6b23-6406-4c86-a080-9009fe11f5fb?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"source": "lakemedelsverket",
"doc_types": [
"EMA",
"EPAR"
],
"se_npl_id": "20230909000038",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20230909000038",
"product_doc_link": "https://www.ema.europa.eu/en/medicines/human/EPAR/balversa"
}See everything about erdafitinib.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.