Lacosamide Accord

RSS

lacosamide

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 07/05/2018

Authorisation details

Product details
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 medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare Ltd
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
18/09/2017
Contact address
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom

Product information

04/04/2018 Lacosamide Accord - EMEA/H/C/004443 -

Contents

  • 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.

Pharmacotherapeutic group

ANTIEPILEPTICS

Therapeutic indication

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.

Assessment history

How useful was this page?

Add your rating
Average
1 rating