United States· US:10122-160_ca12aa63-7344-4996-bfb4-d2289c245f4a
ELFABRIO
A pegunigalsidase alfa product containing pegunigalsidase alfa, registered in United States by Chiesi USA, Inc.. The same ATC class is registered in 12 of our 19 countries.
Checked against FDA National Drug Code directory (United States) 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: United States, from FDA National Drug Code directory (United States)
- 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
FDA National Drug Code directory (United States)- Active substance
- PEGUNIGALSIDASE ALFA
- Manufacturer
- Chiesi USA, Inc.
- Country
- United States (US)
- ATC code
- A16AB20
- ATC class
- Pegunigalsidase alfa
- Defined daily dose
- 5 mg, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 6
- ndc1110122160021 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-02) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
- ndc1110122160055 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-05) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
- ndc11101221601010 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-10) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
- ndc1110122-160-02
- ndc1110122-160-05
- ndc1110122-160-10
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
- FinlandElfabrioChiesi Farmaceutici S.p.A.
- SwitzerlandElfabrio 20 mg/10 ml, solution à diluer pour perfusionChiesi SA
- BelgiumElfabrio 2 mg/mlChiesi Farmaceutici
- 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 FDA National Drug Code directory (United States). 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/b891d7e8-20c3-41c4-a72b-761b7b2b8536 GET /v1/drugs/b891d7e8-20c3-41c4-a72b-761b7b2b8536?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.
{
"route": "INTRAVENOUS",
"source": "ndc",
"strength": "20",
"substance": "PEGUNIGALSIDASE ALFA",
"productndc": "10122-160",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"dea_schedule": null,
"strength_unit": "mg/10mL",
"application_number": "BLA761161",
"marketing_category": "BLA"
}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.