Lacosamide Accord
lacosamide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Lacosamide Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Lacosamide Accord.
For practical information about using Lacosamide Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
Product details | |
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Name |
Lacosamide Accord
|
Agency product number |
EMEA/H/C/004443
|
Active substance |
lacosamide
|
International non-proprietary name (INN) or common name |
lacosamide
|
Therapeutic area (MeSH) |
Epilepsy
|
Anatomical therapeutic chemical (ATC) code |
N03AX18
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
Revision |
12
|
Date of issue of marketing authorisation valid throughout the European Union |
18/09/2017
|
Contact address |
Accord Healthcare S.L.U. |
Product information
04/08/2023 Lacosamide Accord - EMEA/H/C/004443 - IB/0021/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antiepileptics
Therapeutic indication
Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Lacosamide Accord is indicated as adjunctive therapy
• in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
• in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.