Fabrazyme
- Prescription status not stated
- Digestion, stomach, diabetes and nutrition
- Active substance
- Agalsidase beta
- Made by
- Sanofi B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (Fabrazyme). It describes the substance, not this exact product.
FABRAZYME (agalsidase beta) provides an exogenous source of α-galactosidase A in Fabry disease patients.
Agalsidase beta is internalized and transported into lysosomes where it exerts enzymatic activity and reduces accumulated GL-3.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-08-22
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Sanofi B.V. |
|---|---|
| Active substance | Agalsidase beta |
| Used in | Digestion, stomach, diabetes and nutrition |
| Classification | A16AB04 · Digestion, stomach, diabetes and nutrition |
| Authorised on | 2001-08-03 |
| Last updated by the regulator | 2024-09-04 |
| EMA product number | EMEA/H/C/000370 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).