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.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
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
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
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_apb3704939
- be_apb7734379
- be_apb4516100
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.
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.
- CzechiaMIGLUSTAT ACCORDACCORD HEALTHCARE POLSKA Sp. z o.o., Varšava
- FinlandMiglustat AccordOrifarm Oy
- ItalyMIGLUSTAT ACCORDACCORD HEALTHCARE SLU
- SwedenMiglustat Bluefish 100 mg Kapsel, hårdBluefish Pharmaceuticals AB
- SpainMIGLUSTAT ACCORD 100 MG CAPSULAS DURAS EFGAccord Healthcare S.L.U.
- NetherlandsMiglustat Dipharma 100 mg harde capsulesDipharma Arzneimittel GmbH
- FranceMIGLUSTAT ACCORD 100 mg, géluleACCORD HEALTHCARE FRANCE
- United KingdomMiglustat 100mg capsulesFlynn Pharma Ltd
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.