Ireland· IE-PA-EU/1/05/324/001
Naglazyme 1 mg/ml concentrate for solution for infusion
A galsulfase product containing galsulfase, registered in Ireland by BioMarin International Limited. The same ATC class is registered in 14 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Galsulfase is registered in 14 of 19 countries.
Countries holding a registration under ATC A16AB08 (galsulfase), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 9 of them publish a price we can compare per daily dose
Galsulfase · ATC A16AB08
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Galsulfase
- Manufacturer
- BioMarin International Limited
- Country
- Ireland (IE)
- ATC code
- A16AB08
- ATC class
- Galsulfase
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/05/324/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Galsulfase in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaNAGLAZYMEBioMarin International Limited, Dublin
- FinlandNaglazymeBiomarin International Limited
- BelgiumNaglazyme 1 mg/mlBioMarin International
- NorwayNaglazymeBioMarin International Limited
- PolandNaglazymeBioMarin International Ltd.
- SwedenNaglazyme 1 mg/ml Koncentrat till infusionsvätska, lösningBioMarin International Limited
- IcelandNaglazymeBioMarin International Limited
- CanadaNAGLAZYMEBIOMARIN PHARMACEUTICAL INC.
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 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/fa65ca1d-c443-4375-8abb-a87f386ae559 GET /v1/drugs/fa65ca1d-c443-4375-8abb-a87f386ae559?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": [
"A16AB08"
],
"strength": null,
"pa_number": "EU/1/05/324/001",
"substances": [
"Galsulfase"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "24/01/2006",
"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 galsulfase.
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.