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Fabrazyme

Active substance: agalsidase beta

agalsidase beta

Centralised EU authorisationActive

Marketing holder: Sanofi B.V.

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 2
  • Fabrazyme
    INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · AGALSIDASE BETA 5 mg/mL
    58468-0041
    Genzyme Corporation
  • Fabrazyme
    INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · AGALSIDASE BETA 5 mg/mL
    58468-0040
    Genzyme Corporation
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-7e33-7816-8270-d3bd0782ef78,01a12098-db07-7407-8962-3fa3886dedfe;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000370
Registration status
Active
ATC code
A16AB04
Sources
  • product · EMA · EMEA/H/C/000370 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000370 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000370 · Verified 2026-10-09