Levetiracetam Hospira

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levetiracetam

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

Overview

Levetiracetam Hospira is an epilepsy medicine. It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one side of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.

Levetiracetam Hospira can also be used as an add-on to other anti-epileptic medicines to treat:

  • partial-onset seizures with or without generalisation in patients from four years of age;
  • myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
  • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

Levetiracetam Hospira is used as an alternative for patients when oral treatment is temporarily not feasible.

Levetiracetam Hospira contains the active substance levetiracetam and is a ‘generic medicine’. This means that Levetiracetam Hospira contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Keppra.

This EPAR was last updated on 15/06/2022

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
GenericGeneric

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
Pfizer Europe MA EEIG
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
07/01/2014
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

14/06/2022 Levetiracetam Hospira - EMEA/H/C/002783 - IB/0036

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Product information documents contain:

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.

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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