Spain· ES:80512
MITOMICINA ACCORD 2 MG POLVO PARA SOLUCION INTRAVESICAL Y PARA SOLUCION INYECTABLE EFG
A medicinal product containing mitomicina, registered in Spain by Accord Healthcare S.L.U..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- mitomicina
- Manufacturer
- Accord Healthcare S.L.U.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 3, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mitomicina in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NorwayMitomycin medacMedac
- United StatesMitomycinHikma Pharmaceuticals USA Inc.
- BelgiumMitomycin Accord Healthcare 10 mgAccord Healthcare
- United KingdomMitocin 20mg powder and solvent for intravesical solution vialsVygoris Ltd
- GermanyMitemSubstipharm
- CzechiaMITOMYCIN ACCORDACCORD HEALTHCARE POLSKA Sp. z o.o., Varšava
- FinlandMitomycin AccordAccord Healthcare B.V.
- NetherlandsMitomycine Accord 10 mg, poeder voor oplossing voor injectie / infusie of intravesicaal gebruikAccord Healthcare B.V.
Authorised across Europe · EMA
The same active substance is authorised in 25 EEA countries. Names it is sold under:
- Austria · Mitomycin Medac
- Belgium · Mitomycin Accord Healthcare, Mitomycin Medac
- Bulgaria · Митомицин Акорд
- Cyprus · Mitomycin Accord, Mitomycine Substipharm
- Czechia · Mitomycin Accord, Mitomycin Medac
- Germany · Mitem, Mito-Apogepha
- Denmark · Mitomycin Medac
- Estonia · Mitomycin Accord, Mitomycin Medac
- Finland · Mitomycin Accord, Mitomycin Medac
- France · Mitomycine Accord, Mitomycine Medac
- United Kingdom (Northern Ireland) · Mitocin, Mitomycin Accord Healthcare
- Ireland · Mitomycin Medac
- Iceland · Mitomycin Medac
- Italy · Mitomicina Accord, Mitomicina Medac
- Lithuania · Mitomycin Medac
- Latvia · Mitomycin Medac
- Malta · Mitomycine Substipharm
- Netherlands · Mitomycine Accord, Mitomycine Medac
- Norway · Mitomycin Medac, Mitomycin Substipharm
- Poland · Mitomycin Accord
- Portugal · Mitomicina Accord, Mitomicina Accord Healthcare
- Romania · Mitomicină Accord
- Sweden · Mitomycin Medac, Mitomycin Substipharm
- Slovenia · Mitomicin Accord, Mitomicin Medac
- Slovakia · Mitomycin Accord, Mitomycin Medac
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/dcbefad4-e76d-40c3-88ec-5316a1422b49 GET /v1/drugs/dcbefad4-e76d-40c3-88ec-5316a1422b49?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": "Uso Hospitalario",
"estado": "{\"aut\":1469656800000}",
"nregistro": "80512",
"substance": "mitomicina"
}See everything about mitomicina.
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.