Lacosamide Adroiq

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lacosamide

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

Overview

Lacosamide Adroiq 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 with epilepsy aged 2 years and older.

Lacosamide Adroiq 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 Adroiq is a ‘generic medicine’. This means that Lacosamide Adroiq contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Lacosamide Adroiq is Vimpat. For more information on generic medicines, see the question-and-answer document here.

Lacosamide Adroiq contains the active substance lacosamide.

This EPAR was last updated on 14/09/2023

Authorisation details

Product details
Name
Lacosamide Adroiq
Agency product number
EMEA/H/C/006047
Active substance
lacosamide
International non-proprietary name (INN) or common name
lacosamide
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX18
GenericGeneric

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
Marketing-authorisation holder
Extrovis EU Ltd.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
31/05/2023
Contact address

Patriarka utca 14
2000 Szentendre
Hungary

Product information

08/09/2023 Lacosamide Adroiq - EMEA/H/C/006047 - N/0003

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Product information documents contain:

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 Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.

Lacosamide Adroiq is indicated as adjunctive therapy

  • in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 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.

Assessment history

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