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.
Lacosamide Accord : EPAR - Summary for the public (PDF/92.53 KB)
First published: 27/09/2017
Last updated: 27/09/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
Accord Healthcare S.L.U.
|Date of issue of marketing authorisation valid throughout the European Union||
05/03/2019 Lacosamide Accord - EMEA/H/C/004443 - IAIN/0004/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Lacosamide Accord is indicated as monotherapy and 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.