This is a summary of the European public assessment report (EPAR) for Levetiracetam Teva. 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 Teva.
- What is Levetiracetam Teva?
Levetiracetam Teva is a medicine that contains the active substance levetiracetam. It is available as oblong tablets (250 mg, 500 mg, 750 mg and 1,000 mg).
Levetiracetam Teva is a ‘generic medicine’. This means that Levetiracetam Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Keppra.
- What is Levetiracetam Teva used for?
Levetiracetam Teva 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 Teva 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;
- 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 Teva used?
When Levetiracetam Teva 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 Teva 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. The tablets are not suitable for infants and children under 6 years old or weighing less than 25 kg, for whom an oral solution is recommended.
Lower doses are used in patients who have problems with their kidneys (such as older patients).
Levetiracetam Teva tablets are swallowed with liquid.
- How does Levetiracetam Teva work?
The active substance in Levetiracetam Teva, 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 Teva to stabilise electrical activity in the brain and prevent seizures.
- How has Levetiracetam Teva been studied?
Because Levetiracetam Teva 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 are the benefits and risks of Levetiracetam Teva?
Because Levetiracetam Teva 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 Teva been approved?
The CHMP concluded that, in accordance with EU requirements, Levetiracetam Teva 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 Teva be given marketing authorisation.
- Other information about Levetiracetam Teva
The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Teva on 26 August 2011.
For more information about treatment with Levetiracetam Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 31/01/2014 .
03/01/2014 Levetiracetam Teva -EMEA/H/C/002316 -IB/0010
- 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.
Levetiracetam Teva is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Levetiracetam Teva is indicated as adjunctive therapy:
- in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy;
- in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;
- in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Levetiracetam Teva : EPAR - Procedural steps taken and scientific information after authorisation||SV = svenska||21/12/2011||31/01/2014|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Levetiracetam Teva : EPAR - Public assessment report||SV = svenska||19/09/2011|
|CHMP summary of positive opinion for Levetiracetam Teva||SV = svenska||20/05/2011|