Ireland· IE-PA-EU/1/01/189/001
Replagal 1 mg/ml concentrate for solution for infusion
A agalsidase alfa product containing agalsidase alfa, registered in Ireland by Takeda Pharmaceuticals International AG Ireland Branch. The same ATC class is registered in 13 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Agalsidase alfa is registered in 13 of 19 countries.
Countries holding a registration under ATC A16AB03 (agalsidase alfa), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Agalsidase alfa · ATC A16AB03
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
The record
At a glance
HPRA (Ireland)- Active substance
- Agalsidase alfa
- Manufacturer
- Takeda Pharmaceuticals International AG Ireland Branch
- Country
- Ireland (IE)
- ATC code
- A16AB03
- ATC class
- Agalsidase alfa
- Defined daily dose
- 1 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/01/189/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Agalsidase alfa in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaREPLAGALTakeda Pharmaceuticals International AG Ireland Branch, Dublin
- BelgiumReplagal 1 mg/mlTakeda Pharmaceuticals International Ireland Branch
- FinlandReplagalOrifarm Oy
- IcelandReplagalTakeda Pharmaceuticals International AG Ireland Branch
- NorwayReplagalTakeda Pharmaceuticals International AG Ireland Branch
- SwedenReplagal 1 mg/ml Koncentrat till infusionsvätska, lösningTakeda Pharmaceuticals International AG Ireland Branch
- SpainREPLAGAL 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSIONShire Human Genetic Therapies Ab
- United KingdomReplagal 1mg/1ml solution for infusion vialsShire Pharmaceuticals Ltd
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 HPRA (Ireland). 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/c113a94a-51b8-4a5c-88ee-848afa6d9ffd GET /v1/drugs/c113a94a-51b8-4a5c-88ee-848afa6d9ffd?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.
{
"form": "Concentrate for solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"A16AB",
"A16AB03"
],
"strength": null,
"pa_number": "EU/1/01/189/001",
"substances": [
"Agalsidase alfa"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "03/08/2001",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about agalsidase 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.