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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/818898/2011

EMEA/H/C/0002305

EPAR summary for the public

Levetiracetam Actavis Group

levetiracetam

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

What is Levetiracetam Actavis Group?

Levetiracetam Actavis Group is a medicine that contains the active substance levetiracetam. It is available as an oral solution (100 mg/ml).

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

Levetiracetam Actavis Group 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 Actavis Group 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 one 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;

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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).

The medicine can only be obtained with a prescription.

How is Levetiracetam Actavis Group used?

When Levetiracetam Actavis Group 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 Actavis Group 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 six months 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. In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution. This can be increased up to 21 mg/kg twice a day.

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

The oral solution may be mixed in a glass of water before it is taken.

How does Levetiracetam Actavis Group work?

The active substance in Levetiracetam Actavis Group, 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 to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam Actavis Group been studied?

Because Levetiracetam Actavis Group is a generic medicine, studies in patients 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 benefit has Levetiracetam Actavis Group shown during the studies?

Because Levetiracetam Actavis Group 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.

What is the risk associated with Levetiracetam Actavis Group?

The most common side effects with Levetiracetam Actavis Group (seen in more than 1 patient in 10) are somnolence (sleepiness), and asthenia (weakness) or fatigue (tiredness). For the full list of all side effects reported with Levetiracetam Actavis Group, see the package leaflet.

Levetiracetam Actavis Group must not be used in people who are hypersensitive (allergic) to levetiracetam, to other pyrrolidone derivatives (medicines with a similar structure to levetiracetam), or to any of the other ingredients.

Levetiracetam Actavis Group

Why has Levetiracetam Actavis Group been approved?

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

Other information about Levetiracetam Actavis Group

The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Actavis Group on 5 December 2011.

The full EPAR for Levetiracetam Actavis Group 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 Actavis Group, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2011.

Levetiracetam Actavis Group

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