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)
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
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
UCB Pharma SA
|Date of issue of marketing authorisation valid throughout the European Union||
Allée de la Recherche 60
02/09/2021 Keppra - EMEA/H/C/000277 - WS2067
This medicine’s product information is available in all official EU languages.
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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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.