Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
Levetiracetam Actavis is an epilepsy medicine. It 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 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).
Levetiracetam Actavis contains the active substance levetiracetam and is a ‘generic medicine’. This means that Levetiracetam Actavis contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Keppra.
Active Substances (1)
levetiracetam
Documents (9)
CHMP summary of positive opinion for Levetiracetam Actavis
July 21, 2011
CHANGES_SINCE_INITIAL_AUTHORISATION
Levetiracetam Actavis : EPAR - Procedural steps taken and scientific information after authorisation (archive)
May 24, 2012
CHANGES_SINCE_INITIAL_AUTHORISATION
Levetiracetam Actavis : EPAR - Product Information
October 18, 2011
DRUG_PRODUCT_INFORMATION
Levetiracetam Actavis : EPAR - Medicine overview
October 17, 2011
OVERVIEW_DOCUMENT
Levetiracetam Actavis : EPAR - Procedural steps taken and scientific information after authorisation
June 30, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Levetiracetam Actavis : EPAR - Public assessment report
October 17, 2011
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Levetiracetam Actavis : EPAR - Public assessment report
October 17, 2011
CHANGES_SINCE_INITIAL_AUTHORISATION
Levetiracetam Actavis : EPAR - All Authorised presentations
October 17, 2011
AUTHORISED_PRESENTATIONS
CHMP summary of positive opinion for Levetiracetam Actavis
July 21, 2011
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Overview Q&A (7)
Question
How is Levetiracetam Actavis used?
Answer
Levetiracetam Actavis is available as tablets to be swallowed with liquid. It can only be obtained with a prescription.
The usual 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 aged between one month and 17 years weighing less than 50 kg, the dose depends on body weight.
For more information about using Levetiracetam Actavis, see the package leaflet or contact your doctor or pharmacist.
Question
How does Levetiracetam Actavis work?
Answer
The active substance in Levetiracetam Actavis, 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 Actavis to stabilise electrical activity in the brain and prevent seizures.
Question
What measures are being taken to ensure the safe and effective use of Levetiracetam Actavis?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Levetiracetam Actavis have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Levetiracetam Actavis are continuously monitored. Suspected side effects reported with Levetiracetam Actavis are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Levetiracetam Actavis
Answer
Levetiracetam Actavis received a marketing authorisation valid throughout the EU on 3 October 2011.
Question
What are the benefits and risks of Levetiracetam Actavis?
Answer
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.
Question
How has Levetiracetam Actavis been studied?
Answer
The company provided data from the published literature on levetiracetam. Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Keppra, and do not need to be repeated for Levetiracetam Actavis. 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.
Question
Why has Levetiracetam Actavis been approved?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Levetiracetam Actavis has been shown to have comparable quality and to be bioequivalent to Keppra. Therefore, the Agency’s view was that, as for Keppra, the benefits of Levetiracetam Actavis outweigh the identified risks and it can be authorised for use in the EU.