Lacosamide Accord

lacosamide

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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.

What is Lacosamide Accord and what is it used for?

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.

How is Lacosamide Accord used?

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.

How does Lacosamide Accord work?

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.

How has Lacosamide Accord been studied?

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.

What are the benefits and risks of Lacosamide Accord?

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

Why is Lacosamide Accord approved?

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.

What measures are being taken to ensure the safe and effective use of Lacosamide Accord?

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.

Other information about Lacosamide Accord

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.

Name Language First published Last updated
Lacosamide Accord : EPAR - Summary for the public BG = bălgarski 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public ES = español 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public CS = čeština 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public DA = dansk 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public DE = Deutsch 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public ET = eesti keel 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public EL = elliniká 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public EN = English 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public FR = français 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public IT = italiano 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public LV = latviešu valoda 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public LT = lietuvių kalba 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public HU = magyar 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public MT = Malti 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public NL = Nederlands 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public PL = polski 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public PT = português 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public RO = română 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public SK = slovenčina 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public SL = slovenščina 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public FI = suomi 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public SV = svenska 2017-09-27  
Lacosamide Accord : EPAR - Summary for the public HR = Hrvatski 2017-09-27  

This EPAR was last updated on 27/09/2017 .

Authorisation details

Product details

Product details for Lacosamide Accord
NameLacosamide Accord
Agency product numberEMEA/H/C/004443
Active substance

lacosamide

International non-proprietary name (INN) or common name

lacosamide

Therapeutic area Epilepsy
Anatomical therapeutic chemical (ATC) code N03AX18
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Lacosamide Accord
Marketing-authorisation holder

Accord Healthcare Ltd

Revision0
Date of issue of marketing authorisation valid throughout the European Union18/09/2017

Contact address:

Accord Healthcare Ltd
Sage House 
319 Pinner Road North 
Harrow 
Middlesex HA1 4HF
United Kingdom

Product information

Product information

18/09/2017  Lacosamide Accord -EMEA/H/C/004443

Name Language First published Last updated
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - Product Information HR = Hrvatski 2017-09-27  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  
Lacosamide Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-09-27  

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Lacosamide Accord is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent (16-18 years) patients with epilepsy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Lacosamide Accord : EPAR - Public assessment report HR = Hrvatski 2017-09-27  
CHMP summary of positive opinion for Lacosamide Accord HR = Hrvatski 2017-07-21  

Authorised

This medicine is approved for use in the European Union