This is a summary of the European public assessment report (EPAR) for Levetiracetam Actavis. 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.
What is Levetiracetam Actavis?
Levetiracetam Actavis 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 Actavis is a ‘generic medicine’. This means that Levetiracetam Actavis is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Keppra. For more information on generic medicines, see the
What is Levetiracetam Actavis used for?
Levetiracetam Actavis can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat
Levetiracetam Actavis can also be used as an
myoclonic seizures (short,
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The medicine can only be obtained with a prescription.
How is Levetiracetam Actavis used?
When Levetiracetam Actavis 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
When Levetiracetam Actavis is added to another
30 mg/kg twice a day.
Lower doses are used in patients who have problems with their kidneys (such as older patients). Levetiracetam Actavis tablets are swallowed with liquid.
How does Levetiracetam Actavis work?
The active substance in Levetiracetam Actavis, levetiracetam, is an
How has Levetiracetam Actavis been studied?
Because Levetiracetam Actavis 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 Actavis?
Because Levetiracetam Actavis 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 Actavis been approved?
The CHMP concluded that, in accordance with EU requirements, Levetiracetam Actavis 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 be given marketing authorisation.
Other information about Levetiracetam Actavis
The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Actavis on 3 October 2011.
The full EPAR for Levetiracetam Actavis 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, 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