Poland· PL-100391339

Miglustat Accord

A miglustat product containing miglustatum, registered in Poland by Accord Healthcare Polska Sp. z o.o.. The same ATC class is registered in 18 of our 19 countries.

ATC A16AX06

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedMiglustat AccordATCA16AX06REGISTER NO.PL-100391339PACKS LISTED3CHECKEDSeptember 27, 2026

Where it is registered

Miglustat is registered in 18 of 19 countries.

Countries holding a registration under ATC A16AX06 (miglustat), each read from that country’s own register.

  • This record: Poland, from URPL (Poland)
  • 10 of them publish a price we can compare per daily dose

Miglustat · ATC A16AX06

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • Switzerlandprice
  • 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.

Price per daily dose

What a daily dose of miglustat costs, country by country.

Normalised to the WHO defined daily dose (0.3 g), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Miglustat · price per daily dose (0.3 g)

USD · FX 28 Sept 2026

  • CH Switzerland$225.28
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

URPL (Poland)
Active substance
Miglustatum
Manufacturer
Accord Healthcare Polska Sp. z o.o.
Country
Poland (PL)
ATC code
A16AX06
ATC class
Miglustat
Defined daily dose
0.3 g, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 3

  • gtin
    05055565745656
  • gtin
    05055565745649
  • gtin
    03400955051930

Regulatory notes

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

Interactions

1 interaction on record for miglustat.

Graded by severity as the source publishes them — 1 moderate. 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

Miglustat · interactions on record

1 record

  • 1 moderate

Most severe, free to view

  • ImigluceraseA16AB02moderate
  • 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

Miglustat in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All miglustat products

Authorised across Europe · EMA

The same active substance is authorised in 19 EEA countries. Names it is sold under:

  • Austria · Miglustat G.L.
  • Bulgaria · Миглустат G.L.
  • Cyprus · Miglustat Accord
  • Czechia · Miglustat Accord
  • Germany · Miglustat Accord, Miglustat Axunio
  • Denmark · Miglustat Bluefish, Miglustat Waymade
  • Spain · Miglustat Accord, Miglustat Waymade
  • Finland · Miglustat Accord, Miglustat Waymade
  • France · Miglustat Accord, Miglustat Bluefish
  • United Kingdom (Northern Ireland) · Miglustat Accord Healthcare, Miglustat Dipharma
  • Iceland · Miglustat Dipharma, Opfolda
  • Italy · Miglustat Accord, Miglustat Waymade
  • Liechtenstein · Miglustat Dipharma, Opfolda
  • Netherlands · Miglustat G.L., Miglustat Waymade
  • Norway · Miglustat Bluefish, Miglustat Dipharma
  • Portugal · Miglustato Accord
  • Romania · Miglustat Accord
  • Sweden · Miglustat, Miglustat Bluefish
  • Slovakia · Miglustat Accord, Miglustat G.L. Pharma

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/245d8abc-c8f5-4c83-8fe7-57d884a6576f
GET /v1/drugs/245d8abc-c8f5-4c83-8fe7-57d884a6576f?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": "Kapsułki twarde",
  "source": "urpl",
  "strength": "100 mg",
  "packaging": "05055565745656 ¦ Rpz ¦ 127653\n14 kaps.\n05055565745649 ¦ Rpz ¦ 127654\n84 kaps.\n¦ UR/Z/4c/284/25 - 03400955051930",
  "substance": "Miglustatum 100 mg",
  "common_name": "Miglustatum",
  "pl_product_id": "100391339",
  "pozwolenie_nr": "24660",
  "auth_procedure": "MRP",
  "authorisation_validity": "Bezterminowe"
}

See everything about miglustat.

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.