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Elfabrio

Active substance: pegunigalsidase alfa

pegunigalsidase alfa

Centralised EU authorisationActive

Marketing holder: Chiesi Farmaceutici S.p.A

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
  • ELFABRIO
    INJECTION, SOLUTION, CONCENTRATE · PEGUNIGALSIDASE ALFA 5 mg/2.5mL
    10122-165
    Chiesi USA, Inc.
  • ELFABRIO
    INJECTION, SOLUTION, CONCENTRATE · PEGUNIGALSIDASE ALFA 20 mg/10mL
    10122-160
    Chiesi USA, Inc.
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
EMEA/H/C/005618
Registration status
Active
ATC code
A16AB20
Sources
  • product · EMA · EMEA/H/C/005618 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005618 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005618 · Verified 2026-10-09