Iceland· IS-EU/1/04/273/001
Lysodren
A mitotane product containing mitotanum inn, registered in Iceland by Esteve Pharmaceuticals S.A.. The same ATC class is registered in 15 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Mitotanum INN
- Manufacturer
- Esteve Pharmaceuticals S.A.
- Country
- Iceland (IS)
- ATC code
- L01XX23
- ATC class
- Mitotane
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 1
1 priced- ean020282100 stk x1 glasISK 110897
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 StatesLysodrenESTEVE PHARMACEUTICALS, S.A.
- 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
- NetherlandsLysodren 500 mg tablettenEsteve Pharmaceuticals S.A.
- NorwayLysodrenEsteve Pharmaceuticals S.A
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- 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 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/2af0838c-74fc-4280-b253-20a06e48de58 GET /v1/drugs/2af0838c-74fc-4280-b253-20a06e48de58?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": "Tafla",
"source": "lyfjastofnun",
"atc_raw": "L01XX23",
"marketed": true,
"strength": "500 mg",
"ma_number": "EU/1/04/273/001",
"substance": "Mitotanum INN",
"other_info": "Ávísun lyfsins er bundin við sérfræðinga í krabbameinslækningum.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "38126"
}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.