Ireland· IE-PA-EU/1/23/1737/001-002

Opfolda 65 mg hard capsules

A miglustat product containing miglustat, registered in Ireland by Amicus Therapeutics Europe Limited. The same ATC class is registered in 18 of our 19 countries.

ATC A16AX06

Checked against HPRA (Ireland) on September 28, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about miglustatAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

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: Ireland, from HPRA (Ireland)
10 of them publish a price we can compare per daily dose

Search miglustat products by name

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

Open the full comparison — free account Drug prices for market access

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

HPRA (Ireland)

Active substance: Miglustat
Manufacturer: Amicus Therapeutics Europe Limited
Country: Ireland (IE)
ATC code: A16AX06
ATC class: Miglustat
Defined daily dose: 0.3 g, O
Reimbursed: Not published by this register
Source register: HPRA (Ireland)
Last checked: September 28, 2026

Packs & prices · 1

ie_pa_number
EU/1/23/1737/001-002

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

Check miglustat against other medicines How interaction checks work

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 HPRA (Ireland). 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/dd8ee081-a6e8-4282-948d-96ec2bed43d0
GET /v1/drugs/dd8ee081-a6e8-4282-948d-96ec2bed43d0?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",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "A16AX06"
  ],
  "strength": null,
  "pa_number": "EU/1/23/1737/001-002",
  "substances": [
    "Miglustat"
  ],
  "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "26/06/2023",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

API reference MCP server Plans

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.

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