Lacosamide Adroiq
lacosamide
Table of contents
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.
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Lacosamide Adroiq : EPAR - Medicine Overview (PDF/143.42 KB)
First published: 05/06/2023
EMA/162596/2023 -
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Lacosamide Adroiq : EPAR - Risk management plan summary (PDF/196.85 KB)
First published: 05/06/2023
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
|
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 | |
|---|---|
| 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 |
Product information
08/09/2023 Lacosamide Adroiq - EMEA/H/C/006047 - N/0003
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 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.