Iceland· IS-EU/1/05/324/001-002
Naglazyme
A galsulfase product containing galsulfasum inn, registered in Iceland by BioMarin International Limited. The same ATC class is registered in 14 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Galsulfasum INN
- Manufacturer
- BioMarin International Limited
- Country
- Iceland (IS)
- ATC code
- A16AB08
- ATC class
- Galsulfase
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 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
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
- IrelandNaglazyme 1 mg/ml concentrate for solution for infusionBioMarin International Limited
- CanadaNAGLAZYMEBIOMARIN PHARMACEUTICAL INC.
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- 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 Icelandic Medicines Agency (Iceland). 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/d01ec82d-72f4-4bd2-87ea-b080910890cb GET /v1/drugs/d01ec82d-72f4-4bd2-87ea-b080910890cb?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": "Innrennslisþykkni, lausn",
"source": "lyfjastofnun",
"atc_raw": "A16AB08",
"marketed": false,
"strength": "1 mg/ml",
"ma_number": "EU/1/05/324/001-002",
"substance": "Galsulfasum INN",
"other_info": null,
"legal_status": "(R) Lyfseðilsskylt\r\n(H) Sjúkrahúsmerkt",
"ma_issued_serial": "38770"
}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.