Czechia· CZ-0222210
BRINEURA
A cerliponase alfa product containing cerliponase alfa, registered in Czechia by BioMarin International Limited, Dublin. The same ATC class is registered in 10 of our 19 countries.
Checked against SÚKL (Czech Republic) on
Informational only — not a medical device.
Where it is registered
Cerliponase alfa is registered in 10 of 19 countries.
Countries holding a registration under ATC A16AB17 (cerliponase alfa), each read from that country’s own register.
- This record: Czechia, from SÚKL (Czech Republic)
- 6 of them publish a price we can compare per daily dose
Cerliponase alfa · ATC A16AB17
10 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Netherlands
- Polandprice
- United Kingdom
The record
At a glance
SÚKL (Czech Republic)- Active substance
- CERLIPONASE ALFA
- Manufacturer
- BioMarin International Limited, Dublin
- Country
- Czechia (CZ)
- ATC code
- A16AB17
- ATC class
- Cerliponase alfa
- Defined daily dose
- 21 mg, P
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 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
Cerliponase alfa in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumBrineura 150 mgBioMarin International
- SpainBRINEURA 150 MG SOLUCION PARA PERFUSIONBiomarin International Limited
- FinlandBrineuraBiomarin International Limited
- FranceBRINEURA 150 mg, solution pour perfusionBIOMARIN INTERNATIONAL LIMITED (IRLANDE)
- IrelandBrineura 150 mg solution for infusionBioMarin International Limited
- IcelandBrineuraBioMarin International Limited
- NetherlandsBrineura 150 mg oplossing voor infusieBioMarin International Limited
- SwedenBrineura 150 mg Infusionsvätska, lösningBioMarin International Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Brineura
- Liechtenstein · Brineura
- Norway · Brineura
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 SÚKL (Czech Republic). 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/fbb56593-67d1-4fcf-ae7f-366f538f7ca4 GET /v1/drugs/fbb56593-67d1-4fcf-ae7f-366f538f7ca4?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": "INF SOL",
"source": "sukl",
"strength": "150MG",
"pack_size": "2X5ML+1X5ML",
"substance": "CERLIPONASE ALFA",
"cz_kod_sukl": "0222210",
"product_type": "BT",
"substance_codes": "20501",
"registration_state": "R",
"registration_number": "EU/1/17/1192/001"
}See everything about cerliponase 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.