Ireland· IE-PA-EU/1/23/1724/001-003
Elfabrio 2 mg/ml Concentrate for solution for infusion
A pegunigalsidase alfa product containing pegunigalsidase alfa, registered in Ireland by Chiesi Farmaceutici S.p.A.. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Pegunigalsidase alfa is registered in 12 of 19 countries.
Countries holding a registration under ATC A16AB20 (pegunigalsidase alfa), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Pegunigalsidase alfa · ATC A16AB20
12 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Pegunigalsidase Alfa
- Manufacturer
- Chiesi Farmaceutici S.p.A.
- Country
- Ireland (IE)
- ATC code
- A16AB20
- ATC class
- Pegunigalsidase alfa
- Defined daily dose
- 5 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/23/1724/001-003
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pegunigalsidase alfa in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaELFABRIOChiesi Farmaceutici S.p.A., Parma
- SwitzerlandElfabrio 20 mg/10 ml, solution à diluer pour perfusionChiesi SA
- FinlandElfabrioChiesi Farmaceutici S.p.A.
- BelgiumElfabrio 2 mg/mlChiesi Farmaceutici
- United StatesELFABRIOChiesi USA, Inc.
- PolandElfabrioChiesi Farmaceutici S.p.A.
- SwedenElfabrio 2 mg/ml Koncentrat till infusionsvätska, lösningChiesi Farmaceutici S.p.A.
- NorwayElfabrioChiesi Farmaceutici S.p.a.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Elfabrio
- Liechtenstein · Elfabrio
- Norway · Elfabrio
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/07b24cbe-41dd-4191-84ce-4db54947f6cf GET /v1/drugs/07b24cbe-41dd-4191-84ce-4db54947f6cf?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": [
"A16AB",
"A16AB20"
],
"strength": null,
"pa_number": "EU/1/23/1724/001-003",
"substances": [
"Pegunigalsidase Alfa"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "04/05/2023",
"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 pegunigalsidase 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.