Basic Information
Levetiracetam Hospira
Regulatory Information
EMEA/H/C/002783
January 7, 2014
October 23, 2013
25
July 7, 2023
Company Information
Belgium
Boulevard de la Plaine 17 1050 Bruxelles
Pfizer Europe MA EEIG
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.