Spain· ES:1221714001
POMBILITI 105 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
A medicinal product containing cipaglucosidasa alfa, registered in Spain by Amicus Therapeutics Europe Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- cipaglucosidasa alfa
- Manufacturer
- Amicus Therapeutics Europe Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Cipaglucosidasa 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
- 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 AEMPS CIMA (Spain). 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/c0e3d81b-aea3-46b8-aaa5-0491bf51f40a GET /v1/drugs/c0e3d81b-aea3-46b8-aaa5-0491bf51f40a?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":1682409095000}",
"nregistro": "1221714001",
"substance": "cipaglucosidasa alfa"
}See everything about cipaglucosidasa 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.