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.
Checked against URPL (Poland) 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: 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
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
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
- gtin05055565745656
- gtin05055565745649
- gtin03400955051930
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
- FranceMIGLUSTAT ACCORD 100 mg, géluleACCORD HEALTHCARE FRANCE
- SpainMIGLUSTAT ACCORD 100 MG CAPSULAS DURAS EFGAccord Healthcare S.L.U.
- NetherlandsMiglustat Dipharma 100 mg harde capsulesDipharma Arzneimittel GmbH
- SwedenMiglustat Bluefish 100 mg Kapsel, hårdBluefish Pharmaceuticals AB
- United KingdomMiglustat 100mg capsulesAccord-UK Ltd
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.