Spain· ES:06333001
MYOZYME 50 MG POLVO CONCENTRADO PARA SOLUCION PARA PERFUSION
A medicinal product containing alglucosidasa alfa, registered in Spain by Sanofi B.V..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- alglucosidasa alfa
- Manufacturer
- Sanofi B.V.
- 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
Alglucosidasa alfa in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaMYOZYMESanofi B.V., Amsterdam
- FinlandMyozymeOrifarm Oy
- IrelandMyozyme 50 mg powder for concentrate for solution for infusionSanofi B.V.
- NetherlandsMyozyme, poeder voor concentraat voor oplossing voor i.v. infusie 50 mgGenzyme Europe BV
- NorwayMyozymeSanofi B.V.
- PolandMyozymeSanofi B.V.
- BelgiumMyozyme 50 mgSanofi
- SwedenMyozyme 50 mg Pulver till koncentrat till infusionsvätska, lösningSanofi B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Myozyme
- Liechtenstein · Myozyme
- Norway · Myozyme
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/43cedc78-dd86-4d8e-980c-a57854aa5323 GET /v1/drugs/43cedc78-dd86-4d8e-980c-a57854aa5323?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\":1146002400000}",
"nregistro": "06333001",
"substance": "alglucosidasa alfa"
}See everything about alglucosidasa alfa.
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.