Poland· PL-100504658

Balversa

A erdafitinib product containing erdafitinibum, registered in Poland by Janssen-Cilag International N.V.. The same ATC class is registered in 14 of our 19 countries.

ATC L01EN01

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedBalversaATCL01EN01REGISTER NO.PL-100504658PACKS LISTED5CHECKEDSeptember 27, 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: Poland, from URPL (Poland)
  • 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

URPL (Poland)
Active substance
Erdafitinibum
Manufacturer
Janssen-Cilag International N.V.
Country
Poland (PL)
ATC code
L01EN01
ATC class
Erdafitinib
Defined daily dose
9 mg, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 5

  • gtin
    05413868125771
  • gtin
    04150192097022
  • gtin
    07323281006107
  • gtin
    05413868125870
  • gtin
    04150192096889

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 URPL (Poland). 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/068b66aa-444a-491f-872e-a2960a82f2d3
GET /v1/drugs/068b66aa-444a-491f-872e-a2960a82f2d3?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": "Tabletki powlekane",
  "source": "urpl",
  "strength": "3 mg",
  "packaging": "05413868125771 ¦ Rpz ¦ EU/1/24/1841/004 ¦ 157805\n1 butelka 84 tabl.\n¦ UR/Z/4c/024/25 - 04150192097022 ¦ UR/Z/4c/223/24 - 07323281006107\n05413868125870 ¦ Rpz ¦ EU/1/24/1841/003 ¦ 157806\n1 butelka 56 tabl.\n¦ UR/Z/4c/222/24 - 04150192096889\nRpz ¦ EU/1/24/1841/001 ¦ 157807\n56 tabl. w blistrze\nRpz ¦ EU/1/24/1841/002 ¦ 157808\n84 tabl. w blistrze",
  "substance": "Erdafitinibum 3 mg",
  "common_name": "Erdafitinibum",
  "pl_product_id": "100504658",
  "pozwolenie_nr": null,
  "auth_procedure": "CEN",
  "authorisation_validity": null
}

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.