Fabrazyme
agalsidase beta · Sanofi B.V.
AUTHORISED IN THE EUWhat Fabrazyme is used for
Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Fabrazyme
- Active substance
- agalsidase beta
- Disease area
- Fabry Disease
- Medicine group
- Other alimentary tract and metabolism products
- ATC code
- A16AB04
- Marketing authorisation holder
- Sanofi B.V.
- Authorised in the EU since
- 2001
Official information
In the USA
Same active substance: Fabrazyme
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 used for?
Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).
What is the active substance in Fabrazyme?
Fabrazyme contains agalsidase beta.
Who makes Fabrazyme?
The EU marketing authorisation holder is Sanofi B.V..
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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