This is a summary of the European public assessment report (EPAR) for Keppra. 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 Keppra.
Keppra : EPAR - Summary for the public (PDF/152.54 KB) (updated)
First published: 18/09/2009
Last updated: 02/06/2021
Keppra : EPAR - Risk-management-plan summary (PDF/63.41 KB)
First published: 18/03/2021
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UCB Pharma SA
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Allée de la Recherche 60
17/12/2020 Keppra - EMEA/H/C/000277 - WS/1664
- 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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Keppra 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.
Keppra 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.