Spain· ES:04273001
LYSODREN 500 mg COMPRIMIDOS
A medicinal product containing mitotano, registered in Spain by Esteve Pharmaceuticals S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- mitotano
- Manufacturer
- Esteve Pharmaceuticals S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cima_codigo760629100EUR 682.15
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mitotano 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
- 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
- PolandLysodrenHRA Pharma Rare Diseases
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 AEMPS CIMA (Spain). 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/bb9a4a6a-2956-43a0-936d-3c52d8729658 GET /v1/drugs/bb9a4a6a-2956-43a0-936d-3c52d8729658?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.
{
"cpresc": "Diagnóstico Hospitalario",
"estado": "{\"aut\":1091397600000}",
"nregistro": "04273001",
"substance": "mitotano"
}See everything about mitotano.
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.