Iceland· IS-EU/1/23/1724/001-006
Elfabrio
A pegunigalsidase alfa product containing pegunigalsidasum alfa inn, registered in Iceland by Chiesi Farmaceutici S.p.A.*. The same ATC class is registered in 12 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Pegunigalsidasum alfa INN
- Manufacturer
- Chiesi Farmaceutici S.p.A.*
- Country
- Iceland (IS)
- ATC code
- A16AB20
- ATC class
- Pegunigalsidase alfa
- Defined daily dose
- 5 mg, P
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 3
3 priced- ean04938610 ml x5 hglISK 1383367
- ean05548910 ml x1 hglISK 283293
- ean1379162,5 ml x1 hglISK 76784
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.
- SwitzerlandElfabrio
- SpainELFABRIO 2 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSIONChiesi Farmaceutici S.P.A.
- CzechiaELFABRIOChiesi Farmaceutici S.p.A., Parma
- BelgiumElfabrio 2 mg/mlChiesi Farmaceutici
- FinlandElfabrioChiesi Farmaceutici S.p.A.
- United KingdomElfabrio 20mg/10ml concentrate for solution for infusion vialsChiesi Ltd
- United StatesELFABRIOChiesi USA, Inc.
- IrelandElfabrio 2 mg/ml Concentrate for solution for infusionChiesi Farmaceutici S.p.A.
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- 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 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/919c1459-be40-44c4-b08f-f9eea197b579 GET /v1/drugs/919c1459-be40-44c4-b08f-f9eea197b579?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": "Innrennslislyf, lausn",
"source": "lyfjastofnun",
"atc_raw": "A16AB20",
"marketed": true,
"strength": "2 mg/ml",
"ma_number": "EU/1/23/1724/001-006",
"substance": "Pegunigalsidasum alfa INN",
"other_info": "Markaðssetning á Íslandi er háð því að Lyfjastofnun hafi staðfest að sérstök skilyrði er varða öryggi og verkun við notkun lyfsins séu uppfyllt.",
"legal_status": "(R) Lyfseðilsskylt\r\n(H) Sjúkrahúsmerkt",
"ma_issued_serial": "45050"
}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.