Spain· ES:1231737001
OPFOLDA 65 MG CAPSULAS DURAS
A medicinal product containing miglustat, registered in Spain by Amicus Therapeutics Europe Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- miglustat
- Manufacturer
- Amicus Therapeutics Europe Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 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.
- SwitzerlandOpfolda 65 mg, HartkapselnAmicus Therapeutics Switzerland GmbH
- CzechiaOPFOLDAAmicus Therapeutics Europe Limited, Dublin
- 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
- NorwayOpfoldaAmicus 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
- 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/d346cdf5-697f-4da5-a16f-5d059f29ae1c GET /v1/drugs/d346cdf5-697f-4da5-a16f-5d059f29ae1c?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\":1689929986000}",
"nregistro": "1231737001",
"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.