This is a summary of the European public assessment report (EPAR) for Levetiracetam Hospira. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Levetiracetam Hospira.
For practical information about using Levetiracetam Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Levetiracetam Hospira : EPAR - Summary for the public (PDF/80.76 KB)
First published: 20/01/2014
Last updated: 20/01/2014
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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.
Pfizer Europe MA EEIG
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Boulevard de la Plaine 17
09/07/2021 Levetiracetam Hospira - EMEA/H/C/002783 - IB/0030
- 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 Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Levetiracetam Hospira is indicated as adjunctive therapy
- in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years 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.
Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.