Spain· ES:78987
MIGLUSTAT ACCORD 100 MG CAPSULAS DURAS EFG
A medicinal product containing miglustat, registered in Spain by Accord Healthcare S.L.U..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- miglustat
- Manufacturer
- Accord Healthcare S.L.U.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- August 12, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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
- SwedenMiglustat Bluefish 100 mg Kapsel, hårdBluefish Pharmaceuticals AB
- NetherlandsMiglustat Dipharma 100 mg harde capsulesDipharma Arzneimittel GmbH
- PolandMiglustat AccordAccord Healthcare Polska Sp. z o.o.
- United KingdomMiglustat 100mg capsulesSovereign Medical 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
- 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 AEMPS CIMA (Spain). 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/e5e9e377-b98a-4ea9-a66b-cb539d19bd6a GET /v1/drugs/e5e9e377-b98a-4ea9-a66b-cb539d19bd6a?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":1408545787000}",
"nregistro": "78987",
"substance": "miglustat"
}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.