Levetiracetam Hospira

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levetiracetam

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 17/01/2018

Authorisation details

Product details
Name
Levetiracetam Hospira
Agency product number
EMEA/H/C/002783
Active substance
levetiracetam
International non-proprietary name (INN) or common name
levetiracetam
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX14
Generic

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.

Publication details
Marketing-authorisation holder
Hospira UK Limited
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
07/01/2014
Contact address
Horizon, Honey Lane
Hurley, Maidenhead, SL6 6RJ
United Kingdom

Product information

01/11/2017 Levetiracetam Hospira - EMEA/H/C/002783 - N/0017

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

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.

Assessment history

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