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Carbaglu

Active substance: carglumic acid

carglumic acid

Centralised EU authorisationActive

Marketing holder: Tour Hekla

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 4
  • Carbaglu
    TABLET, FOR SUSPENSION · CARGLUMIC ACID 200 mg/1
    52276-312
    Recordati Rare Diseases
  • Carglumic Acid
    TABLET, FOR SUSPENSION · CARGLUMIC ACID 200 mg/1
    71863-114
    Eton Pharmaceuticals, Inc.
  • Carglumic acid
    TABLET, FOR SUSPENSION · CARGLUMIC ACID 200 mg/1
    68475-006
    Navinta LLC
  • Carglumic acid
    TABLET, FOR SUSPENSION · CARGLUMIC ACID 200 mg/1
    35573-459
    Burel Pharmaceuticals, LLC
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-7270-7f29-a3bd-40938620752d,01a1208d-8f51-7296-a381-325f69d8b81c,01a1208d-b6fa-73f1-8dea-02b00279412f,01a1209a-d00d-79b8-82bc-553f0803e024;count=4 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000461
Registration status
Active
ATC code
A16AA05
Sources
  • product · EMA · EMEA/H/C/000461 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000461 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000461 · Verified 2026-10-09