Drug Database
Back to search

France· FR:64569676

FABRAZYME 35 mg, poudre pour solution à diluer pour perfusion

A agalsidase beta product containing agalsidase bêta, registered in France by SANOFI (PAYS-BAS). The same ATC class is registered in 14 of our 19 countries.

ATC A16AB04

Checked against Base de données publique des médicaments — BDPM (France) on

Informational only — not a medical device.

SOURCE REGISTER · FRBase de données publique des médicament…normalisedFABRAZYME 35 mg, poudre pour solution…ATCA16AB04REGISTER NO.FR:64569676PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about agalsidase bêtaAnswers 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: France, from Base de données publique des médicaments — BDPM (France)
  • 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

Base de données publique des médicaments — BDPM (France)
Active substance
AGALSIDASE BÊTA
Manufacturer
SANOFI (PAYS-BAS)
Country
France (FR)
ATC code
A16AB04
ATC class
Agalsidase beta
Defined daily dose
5 mg, P
Reimbursed
No
Source register
Base de données publique des médicaments — BDPM (France)
Last checked
September 12, 2026

Packs & prices · 1

  • cip13
    3400956339747
    1 flacon(s) en verre

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 Base de données publique des médicaments — BDPM (France). 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/694dd4c6-3e30-446b-a79a-44387393ac67
GET /v1/drugs/694dd4c6-3e30-446b-a79a-44387393ac67?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.

{
  "cis": "64569676",
  "date_amm": "2001-08-03",
  "type_amm": "Procédure centralisée",
  "numero_ue": "EU/1/01/188",
  "substance": "AGALSIDASE BÊTA",
  "atc_source": "fr_atc_restore_2026-09-06",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "poudre pour solution à diluer pour perfusion",
  "voies_administration": "intraveineuse",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Non"
}
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