o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/583238/2016

EMEA/H/C/002290

EPAR summary for the public

Levetiracetam Accord

levetiracetam

This is a summary of the European public assessment report (EPAR) for Levetiracetam Accord. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam Accord.

What is Levetiracetam Accord?

Levetiracetam Accord is a medicine that contains the active substance levetiracetam. It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg).

Levetiracetam Accord is a 'generic medicine'. This means that Levetiracetam Accord is similar to a 'reference medicine' already authorised in the European Union (EU) called Keppra. For more information on generic medicines, see the question-and-answer document here.

What is Levetiracetam Accord used for?

Levetiracetam Accord can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where excessive electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.

Levetiracetam Accord can also be used as an add-on to other epilepsy medicines to treat:

•    partial-onset seizures with or without generalisation in patients from 1 month of age;

•    myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to be inherited).

The medicine can only be obtained with a prescription.

How is Levetiracetam Accord used?

When Levetiracetam Accord is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day. The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1,500 mg twice a day.

When Levetiracetam Accord is added to another epilepsy treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. For patients weighing less than 50 kg, the dose depends on body weight. Patients who cannot take tablets should be given a solution containing levetiracetam.

Lower doses are used in patients who have problems with their kidneys (such as older patients). Levetiracetam Accord tablets are swallowed with liquid.

How does Levetiracetam Accord work?

The active substance in Levetiracetam Accord, levetiracetam, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps Levetiracetam Accord to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam Accord been studied?

Because Levetiracetam Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Levetiracetam Accord?

Because Levetiracetam Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Levetiracetam Accord been approved?

The CHMP concluded that, in accordance with EU requirements, Levetiracetam Accord has been shown to have comparable quality and to be bioequivalent to Keppra. Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk. The Committee recommended that Levetiracetam Accord be given marketing authorisation.

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

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

Other information about Levetiracetam Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Accord on3 October 2011.

The full EPAR for Levetiracetam Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Levetiracetam 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.

This summary was last updated in 06-2016.

Page 3/3

Levetiracetam Accord

EMA/583238/2016