Spain· ES:05324001
NAGLAZYME 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION
A medicinal product containing galsulfasa, registered in Spain by Biomarin International Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- galsulfasa
- Manufacturer
- Biomarin International 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
Galsulfasa in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandNaglazyme, Konzentrat zur Herstellung einer InfusionslösungDRAC AG
- CzechiaNAGLAZYMEBioMarin International Limited, Dublin
- CanadaNAGLAZYMEBIOMARIN PHARMACEUTICAL INC.
- FinlandNaglazymeBiomarin International Limited
- FranceNAGLAZYME 1 mg/ml, solution à diluer pour perfusionBIOMARIN INTERNATIONAL LIMITED (IRLANDE)
- United KingdomNaglazyme 5mg/5ml solution for infusion vialsBioMarin (U.K.) Ltd
- IrelandNaglazyme 1 mg/ml concentrate for solution for infusionBioMarin International Limited
- IcelandNaglazymeBioMarin International Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Naglazyme
- Liechtenstein · Naglazyme
- Norway · Naglazyme
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/286fd6d3-e437-4bca-8de2-add182ddea1b GET /v1/drugs/286fd6d3-e437-4bca-8de2-add182ddea1b?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\":1150668000000}",
"nregistro": "05324001",
"substance": "galsulfasa"
}See everything about galsulfasa.
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.