France· FR:65643325
BUSILVEX 6 mg/ml, solution à diluer pour perfusion
A busulfan product containing busulfan, registered in France by PIERRE FABRE MEDICAMENT. The same ATC class is registered in 15 of our 19 countries.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
Where it is registered
Busulfan is registered in 15 of 19 countries.
Countries holding a registration under ATC L01AB01 (busulfan), each read from that country’s own register.
- This record: France, from Base de données publique des médicaments — BDPM (France)
- 8 of them publish a price we can compare per daily dose
Busulfan · ATC L01AB01
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Sweden
- United Kingdom
- United Statesprice
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- BUSULFAN
- Manufacturer
- PIERRE FABRE MEDICAMENT
- Country
- France (FR)
- ATC code
- L01AB01
- ATC class
- Busulfan
- Defined daily dose
- 0.224 g, P
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip1334009572153788 flacon(s) en verre de 10 ml
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
245 interactions on record for busulfan.
Graded by severity as the source publishes them — 34 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
Busulfan · interactions on record
245 records
- 34 severe
- 141 moderate
- 16 minor
- 54 info
Most severe, free to view
- Nalidixic acidJ01MB02severe
- MetronidazoleJ01XD01severe
- ThiotepaL01AC01severe
- CladribineL01BB04severe
- 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
Busulfan in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsBusulfan Eureco-Pharma 6 mg/ml, concentraat voor oplossing voor infusieEureco-Pharma B.V.
- United StatesBusulfanArmas Pharmaceuticals Inc.
- United KingdomBusilvex 60mg/10ml concentrate for solution for infusion ampoulesPierre Fabre Ltd
- SpainBUSILVEX 6 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSIONPierre Fabre Medicament
- GermanyBusulfan AccordAccord Healthcare B.V.
- 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
- Spain · Busulfano Accord, Busulfano Aspen
- 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 Base de données publique des médicaments — BDPM (France). 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/8d145467-9835-4372-aed5-ff98a306f17b GET /v1/drugs/8d145467-9835-4372-aed5-ff98a306f17b?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.
{
"cis": "65643325",
"date_amm": "2003-07-09",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/03/254",
"substance": "BUSULFAN",
"atc_source": "fr_atc_restore_2026-09-06",
"statut_amm": "Autorisation abrogée",
"statut_bdm": "Warning disponibilité",
"forme_pharmaceutique": "solution à diluer pour perfusion",
"voies_administration": "intraveineuse",
"etat_commercialisation": "Non commercialisée",
"surveillance_renforcee": "Non"
}See everything about busulfan.
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.