Levetiracetam Actavis Group
levetiracetam
Table of contents
Overview
Levetiracetam Actavis Group 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 Actavis Group 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 one 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 have a genetic cause).
Levetiracetam Actavis Group contains the active substance levetiracetam and is a ‘generic medicine’. This means that Levetiracetam Actavis Group contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Keppra.
Authorisation details
| Product details | |
|---|---|
| Name |
Levetiracetam Actavis Group
|
| Agency product number |
EMEA/H/C/002305
|
| 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 |
Actavis Group PTC ehf
|
| Revision |
18
|
| Date of issue of marketing authorisation valid throughout the European Union |
04/12/2011
|
| Contact address |
Dalshraun 1 |
Product information
21/06/2023 Levetiracetam Actavis Group - EMEA/H/C/002305 - IB/0029
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Levetiracetam Actavis Group is indicated as adjunctive therapy:
- in the treatment of partial-onset seizures with or without secondary generalisation in adults, 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.