Lacosamide UCB

RSS

lacosamide

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

Overview

Lacosamide UCB is a medicine used on its own or as an add-on to other epilepsy medicines in the treatment of partial-onset seizures (epileptic fits starting in one specific part of the brain) with or without secondary generalisation (where the abnormal electrical activity spreads through the brain) in patients aged 4 years or older.

Lacosamide UCB can also be used as add-on to other epilepsy medicines in the treatment of primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 4 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

Lacosamide UCB contains the active substance lacosamide and is the same as Vimpat, which is already authorised in the EU. The company that makes Vimpat has agreed that its scientific data can be used for Lacosamide UCB (‘informed consent’).

This EPAR was last updated on 29/01/2021

Authorisation details

Product details
Name
Lacosamide UCB
Agency product number
EMEA/H/C/005243
Active substance
lacosamide
International non-proprietary name (INN) or common name
lacosamide
Therapeutic area (MeSH)
Epilepsies, Partial
Anatomical therapeutic chemical (ATC) code
N03AX18
Publication details
Marketing-authorisation holder
UCB Pharma S.A.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
26/08/2019
Contact address

Allée de la Recherche 60
B-1070 Bruxelles
Belgium

Product information

24/11/2020 Lacosamide UCB - EMEA/H/C/005243 - WS/1782

Contents

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Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Lacosamide UCB 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

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