Regulatory PathRegulatory requirements compared

Active substance

Eslicarbazepine

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
APTIOM200MG; 400MG; 600MG; 800MGtablet · oralSUMITOMO PHARMA AMPrescription8 Nov 2013
ESLICARBAZEPINE ACETATE200MG; 400MG; 600MG; 800MGtablet · oralDR REDDYSPrescription29 Jun 2021
ESLICARBAZEPINE ACETATE200MG; 400MG; 600MG; 800MGtablet · oralHETERO LABS LTD VPrescription3 Aug 2023
ESLICARBAZEPINE ACETATE200MG; 400MG; 600MG; 800MGtablet · oralALKEM LABS LTDPrescription6 Oct 2023
ESLICARBAZEPINE ACETATE200MG; 400MG; 600MG; 800MGtablet · oralAPOTEXPrescription7 Dec 2023
ESLICARBAZEPINE ACETATE200MG; 400MG; 600MG; 800MGtablet · oralTORRENTPrescription27 Feb 2024
ESLICARBAZEPINE ACETATE200MG; 400MG; 600MG; 800MGtablet · oralLUPINPrescription27 Mar 2024
ESLICARBAZEPINE ACETATE200MG; 400MG; 600MG; 800MGtablet · oralJUBILANT GENERICSPrescription4 Aug 2025
ESLICARBAZEPINE ACETATE200MG; 400MG; 600MG; 800MGtablet · oralSPH ZHONGXI PHARMPrescription3 Nov 2025
ESLICARBAZEPINE ACETATE200MG; 400MG; 600MG; 800MGtablet · oralAUROBINDO PHARMAPrescription5 Aug 2026

EMA European Union — centrally authorised medicines

Zebinix BIAL - Portela & Ca, S.A. · Authorised · authorised 21 Apr 2009 · ATC N03AF04

Therapeutic indication (EMA)

Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

Exalief BIAL - Portela Ca, S.A. · Lapsed · authorised 21 Apr 2009 · ATC N03AF04

Therapeutic indication (EMA)

Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-ESLICARBAZEPINE02537931200 MGTABLET · ORALAPOTEX INC
APO-ESLICARBAZEPINE02537958400 MGTABLET · ORALAPOTEX INC
APO-ESLICARBAZEPINE02537966600 MGTABLET · ORALAPOTEX INC
APO-ESLICARBAZEPINE02537974800 MGTABLET · ORALAPOTEX INC
AURO-ESLICARBAZEPINE02527421200 MGTABLET · ORALAURO PHARMA INC
AURO-ESLICARBAZEPINE02527448400 MGTABLET · ORALAURO PHARMA INC
AURO-ESLICARBAZEPINE02527456600 MGTABLET · ORALAURO PHARMA INC
AURO-ESLICARBAZEPINE02527464800 MGTABLET · ORALAURO PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACAPTIOM 200 MG TABLET$44.24295per EA1 Jan 2026
US NADACAPTIOM 400 MG TABLET$44.00708per EA23 Sep 2026
US NADACAPTIOM 600 MG TABLET$44.42614per EA23 Sep 2026
US NADACAPTIOM 800 MG TABLET$44.16672per EA23 Sep 2026
US NADACESLICARBAZEPINE 200 MG TABLET$1.67576per EA30 Sep 2026
US NADACESLICARBAZEPINE 400 MG TABLET$1.85082per EA30 Sep 2026
US NADACESLICARBAZEPINE 600 MG TABLET$2.32378per EA30 Sep 2026
US NADACESLICARBAZEPINE 800 MG TABLET$1.72576per EA30 Sep 2026
NHS Drug TariffEslicarbazepine 200mg tablets£68.0060 tablet1 Oct 2026
NHS Drug TariffEslicarbazepine 50mg/1ml oral suspension sugar free£56.67200 ml1 Oct 2026
NHS Drug TariffEslicarbazepine 800mg tablets£25.8730 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 13 Sep 2017 APTIOM — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for eslicarbazepine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.