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.

Lacosamide Accord is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 16 years or older. It can be used to treat partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to other parts of the brain).

Lacosamide Accord is given on its own or combined with other medicines for epilepsy.

Lacosamide Accord contains the active substance lacosamide. It is a ‘generic medicine’. This means that Lacosamide Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Vimpat.

The medicine can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg). The usual starting dose is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines. If the doctor decides that a faster effect is needed, treatment with Lacosamide Accord may be started with a higher first dose (called a loading dose).

If treatment with Lacosamide Accord has to be stopped, the dose should be gradually reduced. For further information, see the package leaflet.

The active substance in Lacosamide Accord, lacosamide, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which lacosamide works is still 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. It is also thought that lacosamide might help protect nerve cells from damage. Together, these actions may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Vimpat, and do not need to be repeated for Lacosamide Accord.

As for every medicine, the company provided studies on the quality of Lacosamide Accord. There was no need for ‘bioequivalence’ studies to investigate whether Lacosamide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the active substance, lacosamide, has been shown to be highly soluble and completely absorbed, meaning that almost 100% of the substance reaches the blood when taken by mouth.

Because Lacosamide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Lacosamide Accord has been shown to be comparable to Vimpat. Therefore, the Agency’s view was that, as for Vimpat, the benefit outweighs the identified risk. The Agency recommended that Lacosamide Accord be approved for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lacosamide Accord have been included in the summary of product characteristics and the package leaflet.

The European Commission granted a marketing authorisation valid throughout the European Union for Lacosamide Accord on 18 September 2017.

For more information about treatment with Lacosamide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website.

Lacosamide Accord : EPAR - Summary for the public

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Product information

Lacosamide Accord : EPAR - Product Information

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Latest procedure affecting product information: IB/0021/G

04/08/2023

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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).

Lacosamide Accord : EPAR - All Authorised presentations

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Product details

Name of medicine
Lacosamide Accord
Active substance
lacosamide
International non-proprietary name (INN) or common name
lacosamide
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX18

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.

Lacosamide Accord is indicated as 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.

•         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Authorisation details

EMA product number
EMEA/H/C/004443

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.

Marketing authorisation holder
Accord Healthcare S.L.U.

Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona
SPAIN

Opinion adopted
20/07/2017
Marketing authorisation issued
18/09/2017
Revision
12

Assessment history

Lacosamide Accord : EPAR - Procedural steps taken and scientific information after authorisation

Lacosamide Accord : EPAR - Public assessment report

CHMP summary of positive opinion for Lacosamide Accord

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