Iceland· IS-EU/1/24/1841/001-002 & EU/1/24/1841/003-004

Balversa

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

ATC L01EN01

Checked against Icelandic Medicines Agency (Iceland) on

Informational only — not a medical device.

SOURCE REGISTER · ISIcelandic Medicines Agency (Iceland)normalisedBalversaATCL01EN01REGISTER NO.IS-EU/1/24/1841/001-0…PACKS 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: Iceland, from Icelandic Medicines Agency (Iceland)
  • 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

Icelandic Medicines Agency (Iceland)
Active substance
Erdafitinib
Manufacturer
Janssen-Cilag International NV*
Country
Iceland (IS)
ATC code
L01EN01
ATC class
Erdafitinib
Defined daily dose
9 mg, O
Reimbursed
Not published by this register
Source register
Icelandic Medicines Agency (Iceland)
Last checked
September 29, 2026

Packs & prices · 1

1 priced
  • ean
    415130
    84 stk x1 glas
    ISK 1440574

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 2 EEA countries. Names it is sold under:

  • 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 Icelandic Medicines Agency (Iceland). 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/e481b951-d9f4-46b6-b572-c51465f70dcf
GET /v1/drugs/e481b951-d9f4-46b6-b572-c51465f70dcf?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": "Filmuhúðuð tafla",
  "source": "lyfjastofnun",
  "atc_raw": "L01EN01",
  "marketed": true,
  "strength": "3 mg",
  "ma_number": "EU/1/24/1841/001-002 & EU/1/24/1841/003-004",
  "substance": "Erdafitinib",
  "other_info": "Ávísun lyfsins er bundin við sérfræðinga í krabbameinslækningum.",
  "legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
  "ma_issued_serial": "45526"
}

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.