Basic Information
Levetiracetam Teva
Regulatory Information
EMEA/H/C/002316
August 25, 2011
May 19, 2011
20
June 21, 2023
Company Information
the netherlands
Swensweg 5 2031GA Haarlem
Teva Pharma B.V.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Levetiracetam Teva 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 Teva is indicated as adjunctive therapy: - in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 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.
Overview Summary
Levetiracetam Teva 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 part 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 Teva can also be used as an add-on to other epilepsy medicines to treat: - partial-onset seizures with or without generalisation in patients from 1 month of age; - myoclonic seizures (short, shock-like jerks of a muscle or 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 be inherited). Levetiracetam Teva contains the active substance levetiracetam and is a ‘generic medicine’. This means that Levetiracetam Teva contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Keppra.