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Sweden· SE-19560123000014

Myleran 2 mg Filmdragerad tablett

A medicinal product containing busulfan, registered in Sweden by Aspen Pharma Trading Limited.

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedMyleran 2 mg Filmdragerad tablettATC—REGISTER NO.SE-19560123000014PACKS LISTED1CHECKEDOctober 1, 2026

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
Busulfan
Manufacturer
Aspen Pharma Trading Limited
Country
Sweden (SE)
ATC code
—
Reimbursed
Not published by this register
Source register
Swedish Medical Products Agency (Sweden)
Last checked
October 1, 2026

Packs & prices · 1

  • se_varunummer
    19560123000014

Regulatory notes

No shortage, Orange Book or US label notes for this record.

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
  • 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
  • Poland · Busulfan Accord, Busulfan Zentiva
  • Portugal · Bussulfano Accord, Myleran
  • Romania · Busulfan Accord, 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 Swedish Medical Products Agency (Sweden). 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/02e72677-1e49-4a98-b5aa-eea5d5e83a33
GET /v1/drugs/02e72677-1e49-4a98-b5aa-eea5d5e83a33?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.

{
  "source": "lakemedelsverket",
  "doc_types": [
    "SmPC",
    "PL"
  ],
  "se_npl_id": "19560123000014",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=19560123000014",
  "product_doc_link": "https://docetp.mpa.se/LMF/Myleran%20film-coated%20tablet%20SmPC_09001bee807a6ab2.pdf"
}

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.