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ELFABRIO

Active substance: pegunigalsidase alfa

INJECTION, SOLUTION, CONCENTRATE · PEGUNIGALSIDASE ALFA 20 mg/10mL

United StatesActive

Marketing holder: Chiesi USA, Inc.

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
  • Elfabrio
    pegunigalsidase alfa
    EMEA/H/C/005618
    Chiesi Farmaceutici S.p.A
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-f956-7566-a3ca-d9c84cc07691,01a1209a-bc60-7ea4-8b3c-3e033ea2ec5b;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
10122-160
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 10122-160 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 10122-160 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 10122-160 · Verified 2026-10-09 · open in source