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Iceland· IS-EU/1/15/1082/001

Galafold

A migalastat product containing migalastatum hýdróklóríð, registered in Iceland by Amicus Therapeutics Europe Limited*. The same ATC class is registered in 16 of our 19 countries.

ATC A16AX14

Checked against Icelandic Medicines Agency (Iceland) on

Informational only — not a medical device.

SOURCE REGISTER · ISIcelandic Medicines Agency (Iceland)normalisedGalafoldATCA16AX14REGISTER NO.IS-EU/1/15/1082/001PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about migalastatum hýdróklóríðAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Migalastat is registered in 16 of 19 countries.

Countries holding a registration under ATC A16AX14 (migalastat), each read from that country’s own register.

  • This record: Iceland, from Icelandic Medicines Agency (Iceland)
  • 11 of them publish a price we can compare per daily dose
Search migalastat products by name

Migalastat · ATC A16AX14

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • 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 migalastat costs, country by country.

Normalised to the WHO defined daily dose (61.5 mg), 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 accountDrug prices for market access

Migalastat · price per daily dose (61.5 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$793.74
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

Icelandic Medicines Agency (Iceland)
Active substance
Migalastatum hýdróklóríð
Manufacturer
Amicus Therapeutics Europe Limited*
Country
Iceland (IS)
ATC code
A16AX14
ATC class
Migalastat
Defined daily dose
61.5 mg, O
Reimbursed
Not published by this register
Source register
Icelandic Medicines Agency (Iceland)
Last checked
September 29, 2026

Packs & prices · 1

1 priced
  • ean
    434967
    14 stk x1 þpakki
    ISK 2796482

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

1 interaction on record for migalastat.

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 migalastat against other medicinesHow interaction checks work

Migalastat · interactions on record

1 record

  • 1 moderate

Most severe, free to view

  • Agalsidase betaA16AB04moderate
  • 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

Migalastat in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All migalastat products

Authorised across Europe · EMA

The same active substance is authorised in 2 EEA countries. Names it is sold under:

  • Liechtenstein · Galafold
  • Norway · Galafold

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 Icelandic Medicines Agency (Iceland). 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/d0772ee4-563a-4e3a-b6cf-70b0307617ca
GET /v1/drugs/d0772ee4-563a-4e3a-b6cf-70b0307617ca?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": "Hart hylki",
  "source": "lyfjastofnun",
  "atc_raw": "A16AX14",
  "marketed": true,
  "strength": "123 mg",
  "ma_number": "EU/1/15/1082/001",
  "substance": "Migalastatum hýdróklóríð",
  "other_info": "Ávísun lyfsins er bundin við sérfræðinga í hjartasjúkdómum og sérfræðinga í nýrnasjúkdómum.",
  "legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
  "ma_issued_serial": "42516"
}
API referenceMCP serverPlans

See everything about migalastat.

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.

Try it freeOpen in the console