Spain· ES:03254002
BUSILVEX 6 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION
A medicinal product containing busulfano, registered in Spain by Pierre Fabre Medicament.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- busulfano
- Manufacturer
- Pierre Fabre Medicament
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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
Busulfano in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesBusulfanMeitheal Pharmaceuticals Inc.
- United KingdomBusilvex 60mg/10ml concentrate for solution for infusion ampoulesPierre Fabre Ltd
- GermanyBusulfan AccordAccord Healthcare B.V.
- NetherlandsBusulfan Eureco-Pharma 6 mg/ml, concentraat voor oplossing voor infusieEureco-Pharma B.V.
- FranceBUSILVEX 6 mg/ml, solution à diluer pour perfusionPIERRE FABRE MEDICAMENT
- PolandBusulfan AccordAccord Healthcare Polska Sp. z o.o.
- CzechiaBUSULFAN FRESENIUS KABIFresenius Kabi Deutschland GmbH, Bad Homburg
- CanadaBUSULFAN FOR INJECTIONSTERIMAX INC
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Busulfan Accord, Myleran
- Belgium · Myleran
- Czechia · Myleran
- Germany · Busulfan Accord, Busulfan Koanaa
- Denmark · Busulfan Zentiva
- Estonia · Myleran
- France · Busulfan Accord, Busulfan Koanaa
- United Kingdom (Northern Ireland) · Busulfan Accord, Busulfan Aspen Pharma Trading Limited
- Greece · Busulfan Bioars
- Croatia · Busulfan Pliva
- Hungary · Busulfan Accord, Busulfan Teva
- Ireland · Myleran
- Iceland · Busulfan Fresenius Kabi, Myleran
- Italy · Busulfan Accord, Busulfan Tillomed
- Liechtenstein · Busulfan Fresenius Kabi
- Lithuania · Myleran
- Luxembourg · Myleran
- Netherlands · Busulfan Teva, Myleran
- Norway · Busulfan Fresenius Kabi
- Poland · Busulfan Accord, Busulfan Zentiva
- Portugal · Bussulfano Accord, Myleran
- Romania · Busulfan Accord, Myleran
- Sweden · Busulfan Zentiva, Myleran
- Slovakia · Myleran
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/fa6866d8-12e4-4bae-9dba-7aba5abb9a3e GET /v1/drugs/fa6866d8-12e4-4bae-9dba-7aba5abb9a3e?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\":1208988000000,\"rev\":1674810649000}",
"nregistro": "03254002",
"substance": "busulfano"
}See everything about busulfano.
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.