Poland· PL-100162716
Naglazyme
A galsulfase product containing galsulfasum, registered in Poland by BioMarin International Ltd.. The same ATC class is registered in 14 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Galsulfasum
- Manufacturer
- BioMarin International Ltd.
- Country
- Poland (PL)
- ATC code
- A16AB08
- ATC class
- Galsulfase
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 2
- gtin05909990614745
- gtin00368135020141
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
- IcelandNaglazymeBioMarin International Limited
- NorwayNaglazymeBioMarin International Limited
- 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 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 URPL (Poland). 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/468ade4f-baa4-41a1-970a-ffd626bae3e3 GET /v1/drugs/468ade4f-baa4-41a1-970a-ffd626bae3e3?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": "Koncentrat do sporządzania roztworu do infuzji",
"source": "urpl",
"strength": "1 mg/ml",
"packaging": "05909990614745 ¦ Rpz ¦ Skasowane ¦ EU/1/05/324/001 ¦ 33439\n1 fiol. 5 ml\nRpz ¦ EU/1/05/324/002 ¦ 104663\n6 fiol. 5 ml\n00368135020141 ¦ Rpz ¦ EU/1/05/324/001 ¦ 166365\n1 fiol. 5 ml",
"substance": "Galsufaze 1 mg",
"common_name": "Galsulfasum",
"pl_product_id": "100162716",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": 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.