Japan· JP-3959428D1021
シパグルコシダーゼ アルファ（遺伝子組換え）
A medicinal product containing シパグルコシダーゼ アルファ（遺伝子組換え）, registered in Japan by アミカス・セラピューティクス, on the national reimbursement list.
Checked against MHLW / PMDA (Japan) on
Informational only — not a medical device.
The record
At a glance
MHLW / PMDA (Japan)- Active substance
- シパグルコシダーゼ アルファ（遺伝子組換え）
- Manufacturer
- アミカス・セラピューティクス
- Country
- Japan (JP)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- MHLW / PMDA (Japan)
- Last checked
- September 25, 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
シパグルコシダーゼ アルファ（遺伝子組換え） in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandPombiliti 105 mg, Pulver für ein Konzentrat zur Herstellung einer InfusionslösungAmicus Therapeutics Switzerland GmbH
- CzechiaPOMBILITIAmicus Therapeutics Europe Limited, Dublin
- United StatesPOMBILITIAMICUS THERAPEUTICS US, LLC
- 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*
- 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 MHLW / PMDA (Japan). 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/dab1c770-6afe-417a-8db4-1ff2e817cafe GET /v1/drugs/dab1c770-6afe-417a-8db4-1ff2e817cafe?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.
{
"spec": "１０５ｍｇ１瓶",
"marks": null,
"source": "mhlw",
"remarks": null,
"yj_code": "3959428D1021",
"category": "注射薬",
"price_yen": 204251,
"generic_name": "シパグルコシダーゼ アルファ（遺伝子組換え）",
"product_name_jp": null,
"therapeutic_class": "3959",
"transitional_expiry": null
}See everything about シパグルコシダーゼ アルファ（遺伝子組換え）.
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.