United States· US:71904-200_378efc18-b873-47fa-b558-5ea92904a165
POMBILITI
A cipaglucosidase alfa product containing cipaglucosidase alfa, registered in United States by AMICUS THERAPEUTICS US, LLC. The same ATC class is registered in 13 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Cipaglucosidase alfa is registered in 13 of 19 countries.
Countries holding a registration under ATC A16AB23 (cipaglucosidase 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
Cipaglucosidase alfa · ATC A16AB23
13 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of cipaglucosidase alfa costs, country by country.
Normalised to the WHO defined daily dose (0.1 g), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Cipaglucosidase alfa · price per daily dose (0.1 g)
USD · FX 28 Sept 2026
- CH Switzerland$1264.16
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- CIPAGLUCOSIDASE ALFA
- Manufacturer
- AMICUS THERAPEUTICS US, LLC
- Country
- United States (US)
- ATC code
- A16AB23
- ATC class
- Cipaglucosidase alfa
- Defined daily dose
- 0.1 g, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- July 19, 2026
Packs & prices · 6
- ndc1171904-200-01
- ndc1171904-200-02
- ndc1171904-200-03
- ndc1171904200011 VIAL, GLASS in 1 CARTON (71904-200-01) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
- ndc11719042000210 VIAL, GLASS in 1 CARTON (71904-200-02) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
- ndc11719042000325 VIAL, GLASS in 1 CARTON (71904-200-03) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Cipaglucosidase alfa in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaPOMBILITIAmicus Therapeutics Europe Limited, Dublin
- SwitzerlandPombiliti 105 mg, Pulver für ein Konzentrat zur Herstellung einer InfusionslösungAmicus Therapeutics Switzerland GmbH
- FrancePOMBILITI 105 mg, poudre pour solution à diluer pour perfusionAMICUS THERAPEUTICS EUROPE (IRLANDE)
- United KingdomPombiliti 105mg powder for concentrate for solution for infusion vialsAmicus Therapeutics UK Operations Ltd
- BelgiumPombiliti 105 mgAmicus Therapeutics Europe
- IcelandPombilitiAmicus Therapeutics Europe Limited*
- Japanシパグルコシダーゼ アルファ(遺伝子組換え)アミカス・セラピューティクス
- NetherlandsPombiliti 105mg, poeder voor concentraat voor oplossing voor injectie/infusieAmicus Therapeutics Europe Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Pombiliti
- Liechtenstein · Pombiliti
- Norway · Pombiliti
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/da848e00-ab21-46f3-a02a-59a86b449aee GET /v1/drugs/da848e00-ab21-46f3-a02a-59a86b449aee?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": "105",
"substance": "CIPAGLUCOSIDASE ALFA",
"productndc": "71904-200",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "BLA761204",
"marketing_category": "BLA"
}See everything about cipaglucosidase 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.