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.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
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
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_idEU/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.
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.
- United StatesLysodrenHRA Pharma Rare Diseases
- United KingdomLysodren 500mg tabletsEsteve RD UK & Ireland Ltd
- SpainLYSODREN 500 mg COMPRIMIDOSEsteve Pharmaceuticals S.A.
- FinlandLysodrenEsteve Pharmaceuticals, S.A
- FranceLYSODREN 500 mg, compriméESTEVE PHARMACEUTICALS (ESPAGNE)
- CanadaLYSODRENHRA PHARMA RARE DISEASES
- IcelandLysodrenEsteve Pharmaceuticals S.A.
- NorwayLysodrenEsteve Pharmaceuticals S.A
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.