Ireland· IE-PA-EU/1/22/1714/001-003
Pombiliti 105 mg powder for concentrate for solution for infusion
A cipaglucosidase alfa product containing cipaglucosidase alfa, registered in Ireland by Amicus Therapeutics Europe Limited. The same ATC class is registered in 13 of our 19 countries.
Checked against HPRA (Ireland) 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: Ireland, from HPRA (Ireland)
- 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
HPRA (Ireland)- Active substance
- Cipaglucosidase alfa
- Manufacturer
- Amicus Therapeutics Europe Limited
- Country
- Ireland (IE)
- ATC code
- A16AB23
- ATC class
- Cipaglucosidase alfa
- Defined daily dose
- 0.1 g, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/22/1714/001-003
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
- SpainPOMBILITI 105 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONAmicus Therapeutics Europe Limited
- FinlandPombilitiAmicus Therapeutics Europe Limited
- United KingdomPombiliti 105mg powder for concentrate for solution for infusion vialsAmicus Therapeutics UK Operations Ltd
- IcelandPombilitiAmicus Therapeutics Europe Limited*
- NorwayPombilitiAmicus Therapeutics Europe Limited
- PolandPombilitiAmicus 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 HPRA (Ireland). 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/8eb90218-37f0-4d71-baaf-9b0c12030faf GET /v1/drugs/8eb90218-37f0-4d71-baaf-9b0c12030faf?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": "Powder for concentrate for solution for injection/infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"A16AB",
"A16AB23"
],
"strength": null,
"pa_number": "EU/1/22/1714/001-003",
"substances": [
"Cipaglucosidase alfa"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "20/03/2023",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}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.