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Netherlands· NL-7f8842930b93

Lysodren 500 mg tabletten

A mitotane product containing mitotaan, registered in Netherlands by Esteve Pharmaceuticals S.A.. The same ATC class is registered in 15 of our 19 countries.

ATC L01XX23

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedLysodren 500 mg tablettenATCL01XX23REGISTER NO.NL-7f8842930b93PACKS LISTED1CHECKEDSeptember 29, 2026

Where it is registered

Mitotane is registered in 15 of 19 countries.

Countries holding a registration under ATC L01XX23 (mitotane), each read from that country’s own register.

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

Mitotane · ATC L01XX23

15 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • 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.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
MITOTAAN
Manufacturer
Esteve Pharmaceuticals S.A.
Country
Netherlands (NL)
ATC code
L01XX23
ATC class
Mitotane
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/04/273

Regulatory notes

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

Interactions

376 interactions on record for mitotane.

Graded by severity as the source publishes them — 193 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

Mitotane · interactions on record

376 records

  • 193 severe
  • 138 moderate
  • 30 minor
  • 15 info

Most severe, free to view

  • RolapitantA04AD14severe
  • NaloxegolA06AH03severe
  • NaldemedineA06AH05severe
  • EliglustatA16AX10severe
  • 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

Mitotane in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All mitotane products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Lysodren
  • Liechtenstein · Lysodren
  • Norway · Lysodren

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/5ff6d56f-8b68-4112-846b-0137a7e7fcc8
GET /v1/drugs/5ff6d56f-8b68-4112-846b-0137a7e7fcc8?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": "Tablet",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/lysodren-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Mitotane",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp71820",
  "excipients": [
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "MACROGOL 3350",
    "MAÏSZETMEEL",
    "SILICIUMDIOXIDE (E 551)"
  ],
  "substances": [
    "MITOTAAN"
  ],
  "leaflet_url": null,
  "authorised_at": "2004/04/28",
  "procedure_number": "EMEA/H/C/000521",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/04/273",
  "additional_monitoring": "N"
}

See everything about mitotane.

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.