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Netherlands· NL-50e5e8818e52

Fabrazyme 35 mg, poeder voor concentraat voor oplossing voor intraveneuze infusie

A agalsidase beta product containing agalsidase beta (recombinant) "genzyme", registered in Netherlands by Genzyme Europe BV. The same ATC class is registered in 14 of our 19 countries.

ATC A16AB04

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedFabrazyme 35 mg, poeder voor concentr…ATCA16AB04REGISTER NO.NL-50e5e8818e52PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about agalsidase beta (recombinant) "genzyme"Answers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Netherlands, from CBG-MEB (Netherlands)
  • 9 of them publish a price we can compare per daily dose
Search agalsidase beta products by name

Agalsidase beta · ATC A16AB04

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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
Open the full comparison — free accountDrug prices for market access

Agalsidase beta · price per daily dose (5 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$638.56
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

CBG-MEB (Netherlands)
Active substance
AGALSIDASE BETA (RECOMBINANT) "GENZYME"
Manufacturer
Genzyme Europe BV
Country
Netherlands (NL)
ATC code
A16AB04
ATC class
Agalsidase beta
Defined daily dose
5 mg, P
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/01/188

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
Check agalsidase beta against other medicinesHow interaction checks work

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All agalsidase beta products

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 CBG-MEB (Netherlands). 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/d4623e31-8a15-4c51-aaff-acada24cf7b8
GET /v1/drugs/d4623e31-8a15-4c51-aaff-acada24cf7b8?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": "Poeder voor oplossing voor injectie",
  "route": "Intraveneus gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/fabrazyme-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Agalsidase Beta",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp71068",
  "excipients": [
    "DINATRIUMWATERSTOFFOSFAAT 7-WATER (E 339)",
    "MANNITOL (D-) (E 421)",
    "NATRIUMDIWATERSTOFFOSFAAT 1-WATER (E 339)",
    "STIKSTOF (HEAD SPACE) (E 941)"
  ],
  "substances": [
    "AGALSIDASE BETA (RECOMBINANT) \"GENZYME\""
  ],
  "leaflet_url": null,
  "authorised_at": "2001/08/03",
  "procedure_number": "EMEA/H/C/000370",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/01/188",
  "additional_monitoring": "N"
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console