Spain· ES:01189004
REPLAGAL 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION
A medicinal product containing agalsidasa alfa, registered in Spain by Shire Human Genetic Therapies Ab.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- agalsidasa alfa
- Manufacturer
- Shire Human Genetic Therapies Ab
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 3, 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
Agalsidasa alfa in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandReplagal, Konzentrat zur Herstellung einer InfusionslösungTakeda Pharma AG
- CzechiaREPLAGALTakeda Pharmaceuticals International AG Ireland Branch, Dublin
- BelgiumReplagal 1 mg/mlTakeda Pharmaceuticals International Ireland Branch
- FinlandReplagalOrifarm Oy
- United KingdomReplagal 1mg/1ml solution for infusion vialsShire Pharmaceuticals Ltd
- NorwayReplagalTakeda Pharmaceuticals International AG Ireland Branch
- FranceREPLAGAL 1 mg/ml, solution à diluer pour perfusionTAKEDA PHARMACEUTICALS INTERNATIONAL (IRLANDE)
- SwedenReplagal 1 mg/ml Koncentrat till infusionsvätska, lösningTakeda Pharmaceuticals International AG Ireland Branch
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Replagal
- Liechtenstein · Replagal
- Norway · Replagal
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/036f2c37-371f-4b7c-a8f1-00b22a42b363 GET /v1/drugs/036f2c37-371f-4b7c-a8f1-00b22a42b363?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\":1116540000000,\"rev\":1776406860000}",
"nregistro": "01189004",
"substance": "agalsidasa alfa"
}See everything about agalsidasa 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.