Overview

Levetiracetam Actavis Group 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 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;
  • 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 Group contains the active substance levetiracetam and is a ‘generic medicine’. This means that Levetiracetam Actavis Group contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Keppra. 

Levetiracetam Actavis Group is available as a solution to be drunk (100 mg/ml).

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 Group, see the package leaflet or contact your doctor or pharmacist.

The active substance in Levetiracetam Actavis Group, levetiracetam, is an epilepsy medicine. Epilepsy is caused by too much electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps levetiracetam to stabilise electrical activity in the brain and prevent seizures.

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 Group. 

As for every medicine, the company provided data on the quality of Levetiracetam Actavis Group. The company also provided information to show that there was no need for a study to show that the medicine was bioequivalent to the reference medicine, since the composition of the two medicines was comparable. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Levetiracetam Actavis Group is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency 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 Agency’s view was that, as for Keppra, the benefits of Levetiracetam Actavis Group outweigh the identified risks and it can be authorised for use in the EU. 

Levetiracetam Actavis Group received a marketing authorisation valid throughout the EU on 5 December 2011.

Levetiracetam Actavis Group : EPAR - Medicine overview

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Product information

Levetiracetam Actavis Group : EPAR - Product Information

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Latest procedure affecting product information: IB/0029

21/06/2023

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Levetiracetam Actavis Group : EPAR - All Authorised presentations

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lietuvių kalba (LT) (42.95 KB - PDF)
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Suomi (FI) (19.87 KB - PDF)
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Product details

Name of medicine
Levetiracetam Actavis Group
Active substance
levetiracetam
International non-proprietary name (INN) or common name
levetiracetam
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX14

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.

Levetiracetam Actavis Group is indicated as adjunctive therapy:

  • in the treatment of partial-onset seizures with or without secondary generalisation in adults, 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.

Authorisation details

EMA product number
EMEA/H/C/002305

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
Actavis Group PTC ehf

Dalshraun 1
220 Hafnarfjörður
Iceland

Marketing authorisation issued
04/12/2011
Revision
18

Assessment history

Levetiracetam Actavis Group : EPAR - Procedural steps taken and scientific information after authorisation

Levetiracetam Actavis Group : EPAR - Public assessment report

CHMP summary of positive opinion for Levetiracetam Actavis Group

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