Czechia· CZ-0271798
OPFOLDA
A miglustat product containing miglustat, registered in Czechia by Amicus Therapeutics Europe Limited, Dublin. The same ATC class is registered in 18 of our 19 countries.
Checked against SÚKL (Czech Republic) 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: Czechia, from SÚKL (Czech Republic)
- 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
SÚKL (Czech Republic)- Active substance
- MIGLUSTAT
- Manufacturer
- Amicus Therapeutics Europe Limited, Dublin
- Country
- Czechia (CZ)
- ATC code
- A16AX06
- ATC class
- Miglustat
- Defined daily dose
- 0.3 g, O
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 2026
Packs & prices · 1
1 priced- cz_kod_sukl02717984CZK 5865.76
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.
- SwitzerlandOpfolda 65 mg, HartkapselnAmicus Therapeutics Switzerland GmbH
- SpainOPFOLDA 65 MG CAPSULAS DURASAmicus Therapeutics Europe Limited
- FinlandOpfoldaAmicus Therapeutics Europe Limited
- FranceOPFOLDA 65 mg, géluleAMICUS THERAPEUTICS EUROPE (IRLANDE)
- United KingdomOpfolda 65mg capsulesAmicus Therapeutics UK Operations Ltd
- IrelandOpfolda 65 mg hard capsulesAmicus Therapeutics Europe Limited
- IcelandOpfoldaAmicus Therapeutics Europe Limited*
- NetherlandsOpfolda 65 mg harde capsulesAmicus Therapeutics Europe Limited
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
- 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 SÚKL (Czech Republic). 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/7eeb22fa-87ec-4428-940b-0167a88d14f0 GET /v1/drugs/7eeb22fa-87ec-4428-940b-0167a88d14f0?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": "CPS DUR",
"source": "sukl",
"strength": "65MG",
"pack_size": "4",
"substance": "MIGLUSTAT",
"cz_kod_sukl": "0271798",
"product_type": null,
"substance_codes": "16508",
"registration_state": "R",
"registration_number": "EU/1/23/1737/001"
}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.