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Belgium· BE-AMP-SAM520862-00

Miglustat Gen.Orph 100 mg

A miglustat product containing miglustat, registered in Belgium by Gen-Orph. The same ATC class is registered in 18 of our 19 countries.

ATC A16AX06

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedMiglustat Gen.Orph 100 mgATCA16AX06REGISTER NO.BE-AMP-SAM520862-00PACKS LISTED3CHECKEDSeptember 26, 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Miglustat
Manufacturer
Gen-Orph
Country
Belgium (BE)
ATC code
A16AX06
ATC class
Miglustat
Defined daily dose
0.3 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 3

  • be_apb
    3704939
  • be_apb
    7734379
  • be_apb
    4516100

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 20 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
  • 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 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/f8fcf16c-1f33-443c-8f1d-7dc6485fa306
GET /v1/drugs/f8fcf16c-1f33-443c-8f1d-7dc6485fa306?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": "Capsule, hard",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Miglustat Gen.Orph 100 mg",
  "name_fr": "Miglustat Gen.Orph 100 mg",
  "name_nl": "Miglustat Gen.Orph 100 mg",
  "amp_code": "SAM520862-00",
  "strengths": [
    "100.0000",
    "100.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Miglustat",
    "Sodium Starch Glycolate (Type A)"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Miglustat",
  "authorisation_numbers": [
    "EU/1/17/1232/001",
    "EU/1/17/1232/002"
  ]
}

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.