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Netherlands· NL-630a3b0b2bbc

Balversa 4 mg filmomhulde tabletten

A erdafitinib product containing erdafitinib, registered in Netherlands by Janssen-Cilag International NV. The same ATC class is registered in 14 of our 19 countries.

ATC L01EN01

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedBalversa 4 mg filmomhulde tablettenATCL01EN01REGISTER NO.NL-630a3b0b2bbcPACKS LISTED1CHECKEDSeptember 29, 2026

Where it is registered

Erdafitinib is registered in 14 of 19 countries.

Countries holding a registration under ATC L01EN01 (erdafitinib), each read from that country’s own register.

  • This record: Netherlands, from CBG-MEB (Netherlands)
  • 8 of them publish a price we can compare per daily dose

Erdafitinib · ATC L01EN01

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of erdafitinib costs, country by country.

Normalised to the WHO defined daily dose (9 mg), the median price runs from $0.55 in France to $621.10 in Switzerland — a ×1128 gap.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Erdafitinib · price per daily dose (9 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$621.10
  • FR France$0.55
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

CBG-MEB (Netherlands)
Active substance
ERDAFITINIB
Manufacturer
Janssen-Cilag International NV
Country
Netherlands (NL)
ATC code
L01EN01
ATC class
Erdafitinib
Defined daily dose
9 mg, O
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/24/1841

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

154 interactions on record for erdafitinib.

Graded by severity as the source publishes them — 56 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Erdafitinib · interactions on record

154 records

  • 56 severe
  • 98 moderate

Most severe, free to view

  • Magnesium carbonateA02AA01severe
  • Magnesium oxideA02AA02severe
  • Magnesium hydroxideA02AA04severe
  • Kombinationen von AluminiumsalzenA02AB10severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All erdafitinib products

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 CBG-MEB (Netherlands). 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/27dad588-309e-4e94-8b57-0d8b072d3b62
GET /v1/drugs/27dad588-309e-4e94-8b57-0d8b072d3b62?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.

{
  "form": "Filmomhulde tablet",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Erdafitinib",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp132283",
  "excipients": [
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "CROSCARMELLOSE  NATRIUM  (E 468)",
    "GLYCEROL MONOCAPRYLOCAPRAAT, TYPE I",
    "IJZEROXIDE GEEL (E 172)",
    "IJZEROXIDE ROOD  (E 172)",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MANNITOL (D-) (E 421)",
    "MEGLUMINE",
    "NATRIUMLAURILSULFAAT",
    "POLYVINYLALCOHOL (E 1203)",
    "TALK (E 553b)",
    "TITAANDIOXIDE (E 171)"
  ],
  "substances": [
    "ERDAFITINIB"
  ],
  "leaflet_url": null,
  "authorised_at": "2024/08/22",
  "procedure_number": "EMEA/H/C/006050",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/24/1841",
  "additional_monitoring": "Y"
}

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.