United States· US:25682-007_341de317-904b-4933-88da-b239c5989871
KANUMA
A sebelipase alfa product containing sebelipase alfa, registered in United States by Alexion Pharmaceuticals, Inc.. The same ATC class is registered in 14 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Sebelipase alfa is registered in 14 of 19 countries.
Countries holding a registration under ATC A16AB14 (sebelipase alfa), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 9 of them publish a price we can compare per daily dose
Sebelipase alfa · ATC A16AB14
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- SEBELIPASE ALFA
- Manufacturer
- Alexion Pharmaceuticals, Inc.
- Country
- United States (US)
- ATC code
- A16AB14
- ATC class
- Sebelipase alfa
- Defined daily dose
- 5 mg, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- July 26, 2026
Packs & prices · 2
- ndc1125682-007-01
- ndc1125682007011 VIAL, GLASS in 1 CARTON (25682-007-01) / 10 mL in 1 VIAL, GLASS
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sebelipase alfa in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumKanuma 2 mg/mlAlexion Europe
- SwitzerlandKanuma 2 mg/ml, Konzentrat zur Herstellung einer InfusionslösungAlexion Pharma GmbH
- CzechiaKANUMAAlexion Europe SAS, Levallois-Perret
- FinlandKANUMAAlexion Europe SAS
- IrelandKANUMA 2 mg/ml concentrate for solution for infusionAlexion Europe SAS
- IcelandKanumaAlexion Europe SAS
- NorwayKanumaAlexion Europe SAS (2)
- SwedenKanuma 2 mg/ml Koncentrat till infusionsvätska, lösningAlexion Europe SAS
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Kanuma
- Liechtenstein · Kanuma
- Norway · Kanuma
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/aa4627cf-4b92-4284-98f2-780502e479dd GET /v1/drugs/aa4627cf-4b92-4284-98f2-780502e479dd?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": "2",
"substance": "SEBELIPASE ALFA",
"productndc": "25682-007",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "BLA125561",
"marketing_category": "BLA"
}See everything about sebelipase 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.