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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/884002/2011

EMEA/H/C/002051

EPAR summary for the public

Levetiracetam Sun

levetiracetam

This is a summary of the European public assessment report (EPAR) for Levetiracetam Sun. 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 Sun.

What is Levetiracetam Sun?

Levetiracetam Sun is a medicine that contains the active substance levetiracetam. It is available as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).

Levetiracetam Sun is a 'generic medicine'. This means that Levetiracetam Sun 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 Sun used for?

Levetiracetam Sun 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 too much 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 Sun can also be used as an add-on to other anti-epileptic medicines to treat:

• partial-onset seizures with or without generalisation in patients from four years 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;

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• 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 have a genetic cause).

Levetiracetam Sun is used as an alternative for patients when oral treatment is temporarily not feasible.

The medicine can only be obtained with a prescription.

How is Levetiracetam Sun used?

When Levetiracetam Sun 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 Sun is added to another anti-epileptic 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. In patients aged between four and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.

Lower doses are used in patients who have problems with their kidneys (such as older patients).

The use of Levetiracetam Sun infusion should be temporary.

How does Levetiracetam Sun work?

The active substance in Levetiracetam Sun, levetiracetam, is an anti epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells. This helps Levetiracetam Sun to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam Sun been studied?

The company provided data from the published literature on levetiracetam. No additional studies in patients were needed as Levetiracetam Sun is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Keppra.

What are the benefits and risks of Levetiracetam Sun?

Because Levetiracetam Sun 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 Sun been approved?

The CHMP concluded that, in accordance with EU requirements, Levetiracetam Sun 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 Sun be given marketing authorisation.

Levetiracetam Sun

Other information about Levetiracetam Sun

The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Sun on 14 December 2011.

The full EPAR for Levetiracetam Sun 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 Sun, 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 11-2011.

Levetiracetam Sun

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