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Exalief

Active substance: eslicarbazepine

eslicarbazepine acetate

Centralised EU authorisationActive

Marketing holder: BIAL - Portela Ca, S.A.

Verified 2026-10-09 · EMA

Analogues in other countries
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 41
  • Aptiom
    TABLET · ESLICARBAZEPINE ACETATE 400 mg/1
    63402-204
    Sumitomo Pharma America, Inc.
  • Aptiom
    TABLET · ESLICARBAZEPINE ACETATE 800 mg/1
    63402-208
    Sumitomo Pharma America, Inc.
  • Aptiom
    TABLET · ESLICARBAZEPINE ACETATE 200 mg/1
    63402-202
    Sumitomo Pharma America, Inc.
  • Aptiom
    TABLET · ESLICARBAZEPINE ACETATE 600 mg/1
    63402-206
    Sumitomo Pharma America, Inc.
  • Aptiom
    KIT · eslicarbazepine acetate
    63402-248
    Sumitomo Pharma America, Inc.
All products in this country (41)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-48c2-7e48-a8cb-8eebab6cc7e2,01a1208c-48c4-7390-8503-d7571bc7dd78,01a1208c-8133-793b-b4c7-1fd3738d594f,01a1208c-8135-7b55-92a0-3e9ab01e7f8f,01a1208c-81f0-7ddb-8f96-94713926b0d6;count=41 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000987
Registration status
Active
ATC code
N03AF04
Sources
  • product · EMA · EMEA/H/C/000987 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000987 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000987 · Verified 2026-10-09