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Fabrazyme

Active substance: agalsidase beta

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · AGALSIDASE BETA 5 mg/mL

United StatesActive

Marketing holder: Genzyme Corporation

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 1
  • Fabrazyme
    agalsidase beta
    EMEA/H/C/000370
    Sanofi B.V.
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
58468-0040
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 58468-0040 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 58468-0040 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 58468-0040 · Verified 2026-10-09 · open in source