Poland· PL-100383133
Busulfan Zentiva
A busulfan product containing busulfanum, registered in Poland by Zentiva, k.s.. The same ATC class is registered in 15 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Busulfanum
- Manufacturer
- Zentiva, k.s.
- Country
- Poland (PL)
- ATC code
- L01AB01
- ATC class
- Busulfan
- Defined daily dose
- 0.224 g, P
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 2
- gtin05909991401702
- gtin05909991401719
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.
- BelgiumBusilvex 6 mg/mlPierre Fabre Médicament
- CzechiaBUSULFAN FRESENIUS KABIFresenius Kabi Deutschland GmbH, Bad Homburg
- FinlandBusilvexPierre Fabre Medicament
- SwedenBusulfan Fresenius Kabi 6 mg/ml Koncentrat till infusionsvätska, lösningFresenius Kabi Deutschland GmbH
- United StatesBusulfanSagent Pharmaceuticals
- IrelandBusulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusionFresenius Kabi Deutschland GmbH
- IcelandBusulfan Fresenius KabiFresenius Kabi Deutschland GmbH
- NorwayBusulfan Fresenius KabiFresenius Kabi Deutschland GmbH
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
- 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
- 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 URPL (Poland). 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/cc9e2420-a10b-4c00-b6c9-3b25e8f51966 GET /v1/drugs/cc9e2420-a10b-4c00-b6c9-3b25e8f51966?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": "Koncentrat do sporządzania roztworu do infuzji",
"source": "urpl",
"strength": "6 mg/ml",
"packaging": "05909991401702 ¦ Rpz ¦ 132421\n1 fiol. 10 ml\n05909991401719 ¦ Rpz ¦ 132422\n8 fiol. 10 ml",
"substance": "Busulfanum 6 mg/ml",
"common_name": "Busulfanum",
"pl_product_id": "100383133",
"pozwolenie_nr": "25286",
"auth_procedure": "DCP",
"authorisation_validity": "Bezterminowe"
}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.