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Naglazyme

Active substance: galsulfase

galsulfase

Centralised EU authorisationActive

Marketing holder: BioMarin International Limited

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
  • NAGLAZYME
    SOLUTION · GALSULFASE 5 mg/5mL
    68135-020
    BioMarin Pharmaceutical Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12090-95fe-73b5-8065-6c136990f3c3;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000640
Registration status
Active
ATC code
A16AB
Sources
  • product · EMA · EMEA/H/C/000640 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000640 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000640 · Verified 2026-10-09