Lacosamide Adroiq
Authorised
This medicine is authorised for use in the European Union
lacosamide
MedicineHumanAuthorised
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.
Lacosamide Adroiq is available as a solution for infusion (drip) into a vein and is given twice a day.
The medicine can only be obtained with a prescription.
For more information about using Lacosamide Adroiq, see the package leaflet or contact your doctor or pharmacist.
The active substance in Lacosamide Adroiq, lacosamide, is an epilepsy medicine. Epilepsy is caused by abnormal electrical activity in the brain. The exact way in which lacosamide works is unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells. This action may prevent abnormal electrical activity in the brain, reducing the chance of an epileptic fit.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Vimpat, and do not need to be repeated for Lacosamide Adroiq.
As for every medicine, the company provided studies on the quality of Lacosamide Adroiq. There was no need for ‘bioequivalence’ studies to investigate whether Lacosamide Adroiq is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Lacosamide Adroiq is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Because Lacosamide Adroiq is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
For the list of side effects and restrictions with Lacosamide Adroiq, see the package leaflet.
The European Medicines Agency concluded that, in accordance with EU requirements, Lacosamide Adroiq has been shown to be comparable to Vimpat. Therefore, the Agency’s view was that, as for Vimpat, the benefits of Lacosamide Adroiq outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lacosamide Adroiq have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Lacosamide Adroiq are continuously monitored. Suspected side effects reported with Lacosamide Adroiq are carefully evaluated and any necessary action taken to protect patients.
Lacosamide Adroiq received a marketing authorisation valid throughout the EU on 31 May 2023.
Product information
Latest procedure affecting product information: N/0006
13/03/2024
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).
Product details
- Name of medicine
- Lacosamide Adroiq
- Active substance
- lacosamide
- International non-proprietary name (INN) or common name
- lacosamide
- Therapeutic area (MeSH)
- Epilepsy
- Anatomical therapeutic chemical (ATC) code
- N03AX18
Pharmacotherapeutic group
AntiepilepticsTherapeutic 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.
News on Lacosamide Adroiq
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