Belgium· BE-AMP-SAM058615-00

Myleran 2 mg

A busulfan product containing busulfan, registered in Belgium by Aspen Pharma Trading. The same ATC class is registered in 15 of our 19 countries.

ATC L01AB01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedMyleran 2 mgATCL01AB01REGISTER NO.BE-AMP-SAM058615-00PACKS LISTED2CHECKEDSeptember 26, 2026

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Busulfan
Manufacturer
Aspen Pharma Trading
Country
Belgium (BE)
ATC code
L01AB01
ATC class
Busulfan
Defined daily dose
0.224 g, P
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

1 priced
  • be_apb
    1628023
    EUR 74.4
  • be_apb
    0712307

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All busulfan products

Authorised across Europe · EMA

The same active substance is authorised in 24 EEA countries. Names it is sold under:

  • Austria · Busulfan Accord, 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
  • 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 FAMHP / AFMPS (Belgium). 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/d09588a0-7b0b-4df5-9165-2b289f267734
GET /v1/drugs/d09588a0-7b0b-4df5-9165-2b289f267734?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": "Film-coated tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Myleran 2 mg",
  "name_fr": "Myleran 2 mg",
  "name_nl": "Myleran 2 mg",
  "amp_code": "SAM058615-00",
  "strengths": [
    "2.0000",
    "2.0000",
    "92.5000"
  ],
  "pack_count": 1,
  "substances": [
    "Busulfan",
    "Lactose"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Busulfan",
  "authorisation_numbers": [
    "BE058615"
  ]
}

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.