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EMA Product

Fabrazyme

Product approved by European Medicines Agency (EU)

Basic Information

Fabrazyme

Regulatory Information

EMEA/H/C/000370

Authorised

August 3, 2001

March 29, 2001

37

September 4, 2024

Company Information

Netherlands

Paasheuvelweg 25 1105 BP Amsterdam

Sanofi B.V.

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).

Overview Summary

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

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