Fabrazyme
Fabrazyme ingredients
| Active ingredient | Strength |
|---|---|
| Agalsidase Beta | 5 mg/mL |
What Fabrazyme is used for
The FDA lists the approved uses on the official label (below). In the EU, agalsidase beta is approved as Fabrazyme for:
Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Fabrazyme
- Generic name
- Agalsidase beta
- Made by
- Genzyme Corporation
- Forms
- Injection, Powder, Lyophilized, For Solution
- Given
- Intravenous
- Drug class
- Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme
- FDA approval
- Biologic licence (BLA) BLA103979
- On the US market since
- 2008
Official information
- Fabrazyme prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Agalsidase beta)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Fabrazyme?
Fabrazyme (Agalsidase beta) is a specialist medicine made by Genzyme Corporation, approved by the US FDA.
What are the ingredients of Fabrazyme?
Fabrazyme contains Agalsidase Beta (5 mg/mL).
Is Fabrazyme approved in Europe?
The same active substance is approved in the EU as Fabrazyme.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA