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.
Levetiracetam Actavis : EPAR - Summary for the public (PDF/60.76 KB)
First published: 18/10/2011
Last updated: 18/10/2011
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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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10/09/2019 Levetiracetam Actavis - EMEA/H/C/002355 - IB/0025
- 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
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Levetiracetam Actavis 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 is indicated as adjunctive therapy:
- in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one 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.