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France· FR:61255179

MIGLUSTAT GEN.ORPH 100 mg, gélule

A miglustat product containing miglustat, registered in France by GEN.ORPH. The same ATC class is registered in 18 of our 19 countries.

ATC A16AX06

Checked against Base de données publique des médicaments — BDPM (France) on

Informational only — not a medical device.

SOURCE REGISTER · FRBase de données publique des médicament…normalisedMIGLUSTAT GEN.ORPH 100 mg, géluleATCA16AX06REGISTER NO.FR:61255179PACKS LISTED2CHECKEDSeptember 12, 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: France, from Base de données publique des médicaments — BDPM (France)
  • 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

Base de données publique des médicaments — BDPM (France)
Active substance
MIGLUSTAT
Manufacturer
GEN.ORPH
Country
France (FR)
ATC code
A16AX06
ATC class
Miglustat
Defined daily dose
0.3 g, O
Reimbursed
No
Source register
Base de données publique des médicaments — BDPM (France)
Last checked
September 12, 2026

Packs & prices · 2

  • cip13
    3400930130964
    Plaquette(s) thermoformée(s) OPA : polyamide orienté aluminium PVC de 84 (7x12) gélule(s)
  • cip13
    3400930248959
    Plaquette(s) thermoformée(s) OPA : polyamide orienté aluminium PVC de 84 x 1 gélule (dose unitaire)

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
  • 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
  • Poland · Miglustat, Miglustat Accord
  • 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 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/d00c2e00-d565-4392-8cb6-35844a6a9aa5
GET /v1/drugs/d00c2e00-d565-4392-8cb6-35844a6a9aa5?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": "61255179",
  "date_amm": "2017-11-10",
  "type_amm": "Procédure centralisée",
  "numero_ue": "EU/1/17/1232",
  "substance": "MIGLUSTAT",
  "atc_source": "fr_atc_restore_2026-09-06",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "gélule",
  "voies_administration": "orale",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Non"
}

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.