Belgium· BE-AMP-SAM661458-00
Pombiliti 105 mg
A cipaglucosidase alfa product containing cipaglucosidase alfa, registered in Belgium by Amicus Therapeutics Europe. The same ATC class is registered in 13 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Cipaglucosidase Alfa
- Manufacturer
- Amicus Therapeutics Europe
- Country
- Belgium (BE)
- ATC code
- A16AB23
- ATC class
- Cipaglucosidase alfa
- Defined daily dose
- 0.1 g, P
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 3
- be_apb4967899
- be_apb7746811
- be_apb4969697
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
- 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
- IrelandPombiliti 105 mg powder for concentrate for solution for infusionAmicus Therapeutics Europe Limited
- 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 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/017b3a2d-5c01-46b1-9e72-7a3e034abacc GET /v1/drugs/017b3a2d-5c01-46b1-9e72-7a3e034abacc?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 infusion",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Pombiliti 105 mg",
"name_fr": "Pombiliti 105 mg",
"name_nl": "Pombiliti 105 mg",
"amp_code": "SAM661458-00",
"strengths": [
"105.0000",
"105.0000",
"10.5000"
],
"pack_count": 3,
"substances": [
"Cipaglucosidase Alfa",
"Mannitol",
"Polysorbate 80",
"Sodium"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Cipaglucosidase Alfa",
"authorisation_numbers": [
"EU/1/22/1714/001",
"EU/1/22/1714/003",
"EU/1/22/1714/002"
]
}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.