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Brineura

Active substance: cerliponase alfa

KIT · cerliponase alfa

United StatesActive

Marketing holder: BioMarin Pharmaceutical 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
  • Brineura
    cerliponase alfa
    EMEA/H/C/004065
    BioMarin International Limited
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12090-960b-705a-9f48-a414893a1e77;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
68135-811
Registration status
Active
Dispensing
Prescription only
Sources
  • product · openFDA NDC · 68135-811 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 68135-811 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 68135-811 · Verified 2026-10-09 · open in source