Ireland· IE-PA-EU/1/17/1192/001
Brineura 150 mg solution for infusion
A enzymes product containing cerliponase, registered in Ireland by BioMarin International Limited. The same ATC class is registered in 3 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Cerliponase is registered in 3 of 19 countries.
Countries holding a registration under ATC A16AB (enzymes), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 2 of them publish a price we can compare per daily dose
Cerliponase · ATC A16AB
3 / 19 countries
- Czechiaprice
- Icelandprice
- Ireland
The record
At a glance
HPRA (Ireland)- Active substance
- Cerliponase
- Manufacturer
- BioMarin International Limited
- Country
- Ireland (IE)
- ATC code
- A16AB
- ATC class
- Enzymes
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/17/1192/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Cerliponase 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
- CzechiaBRINEURABioMarin International Limited, Dublin
- SpainBRINEURA 150 MG SOLUCION PARA PERFUSIONBiomarin International Limited
- FinlandBrineuraBiomarin International Limited
- FranceBRINEURA 150 mg, solution pour perfusionBIOMARIN INTERNATIONAL LIMITED (IRLANDE)
- 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 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/baa89148-273e-42d2-b936-1cf1a7e34038 GET /v1/drugs/baa89148-273e-42d2-b936-1cf1a7e34038?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": "Solution for infusion",
"routes": [
"Intracerebral use"
],
"source": "hpra",
"atc_all": [
"A16AB"
],
"strength": null,
"pa_number": "EU/1/17/1192/001",
"substances": [
"Cerliponase"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": null,
"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 cerliponase.
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.