Belgium· BE-AMP-SAM661439-00
Elfabrio 2 mg/ml
A pegunigalsidase alfa product containing pegunigalsidase alfa, registered in Belgium by Chiesi Farmaceutici. The same ATC class is registered in 12 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Pegunigalsidase Alfa
- Manufacturer
- Chiesi Farmaceutici
- Country
- Belgium (BE)
- ATC code
- A16AB20
- ATC class
- Pegunigalsidase alfa
- Defined daily dose
- 5 mg, P
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
- be_apb7739378
- be_apb4776043
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
- FinlandElfabrioOrifarm Oy
- SwitzerlandElfabrio 20 mg/10 ml, solution à diluer pour perfusionChiesi SA
- United StatesELFABRIOChiesi USA, Inc.
- SwedenElfabrio 2 mg/ml Koncentrat till infusionsvätska, lösningChiesi Farmaceutici S.p.A.
- IrelandElfabrio 2 mg/ml Concentrate for solution for infusionChiesi Farmaceutici S.p.A.
- NorwayElfabrioChiesi Farmaceutici S.p.a.
- PolandElfabrioChiesi 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 FAMHP / AFMPS (Belgium). 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/860c47b3-8dde-4df1-b8e9-b6f94826783f GET /v1/drugs/860c47b3-8dde-4df1-b8e9-b6f94826783f?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Elfabrio 2 mg/ml",
"name_fr": "Elfabrio 2 mg/ml",
"name_nl": "Elfabrio 2 mg/ml",
"amp_code": "SAM661439-00",
"strengths": [
"2.0000",
"2.0000",
"48.0000"
],
"pack_count": 3,
"substances": [
"Pegunigalsidase Alfa",
"Sodium"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Pegunigalsidase Alfa",
"authorisation_numbers": [
"EU/1/23/1724/001",
"EU/1/23/1724/003",
"EU/1/23/1724/002"
]
}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.