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Elaprase

Active substance: idursulfase

idursulfase

Centralised EU authorisationActive

Marketing holder: Takeda Pharmaceuticals International AG Ireland Branch

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 1
  • ELAPRASE
    SOLUTION, CONCENTRATE · IDURSULFASE 6 mg/3mL
    54092-700
    Takeda Pharmaceuticals America, Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1209d-83cf-74e9-a312-7848ab10c053;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000700
Registration status
Active
ATC code
A16AB09
Sources
  • product · EMA · EMEA/H/C/000700 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000700 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000700 · Verified 2026-10-09