Ireland· IE-PA-EU/1/01/188/004-006
Fabrazyme 5 mg powder for concentrate for solution for infusion
A agalsidase beta product containing protein c agalsidase beta (recombinant human-a-galactoside a), registered in Ireland by Sanofi B.V.. The same ATC class is registered in 14 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Agalsidase beta is registered in 14 of 19 countries.
Countries holding a registration under ATC A16AB04 (agalsidase beta), 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
Agalsidase beta · ATC A16AB04
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of agalsidase beta costs, country by country.
Normalised to the WHO defined daily dose (5 mg), 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
Agalsidase beta · price per daily dose (5 mg)
USD · FX 28 Sept 2026
- CH Switzerland$638.56
The record
At a glance
HPRA (Ireland)- Active substance
- Protein c agalsidase beta (recombinant human-a-galactoside a)
- Manufacturer
- Sanofi B.V.
- Country
- Ireland (IE)
- ATC code
- A16AB04
- ATC class
- Agalsidase beta
- Defined daily dose
- 5 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/01/188/004-006
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
4 interactions on record for agalsidase beta.
Graded by severity as the source publishes them — 3 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Agalsidase beta · interactions on record
4 records
- 3 severe
- 1 moderate
Most severe, free to view
- AmiodaroneC01BD01severe
- GentamicinJ01GB03severe
- ChloroquineP01BA01severe
- MigalastatA16AX14moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Agalsidase beta in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandFabrazymeSanofi B.V.
- CzechiaFABRAZYMESanofi B.V., Amsterdam
- SpainFABRAZYME 5 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONSanofi B.V.
- BelgiumFabrazyme 5 mgSanofi
- United KingdomFabrazyme 5mg powder for concentrate for solution for infusion vialsSanofi
- NorwayFabrazymeSanofi B.V.
- PolandFabrazymeSanofi B.V.
- Japanアガルシダーゼベータ（遺伝子組換え）サノフィ
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Fabrazyme
- Liechtenstein · Fabrazyme
- Norway · Fabrazyme
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/c6734761-5a4f-40af-b7d0-3e6a59ac6dc8 GET /v1/drugs/c6734761-5a4f-40af-b7d0-3e6a59ac6dc8?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",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"A16AB",
"A16AB04"
],
"strength": null,
"pa_number": "EU/1/01/188/004-006",
"substances": [
"Protein c agalsidase beta (recombinant human-a-galactoside a)"
],
"legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": null,
"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 agalsidase beta.
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.