Levetiracetam Actavis Group
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 : EPAR - Medicine overview (PDF/147.32 KB)Adopted
First published: 14/12/2011
Last updated: 07/09/2021
Levetiracetam Actavis Group
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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.
Actavis Group PTC ehf
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29/06/2022 Levetiracetam Actavis Group - EMEA/H/C/002305 - IB/0026
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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).
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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.