Levetiracetam Sun
levetiracetam
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Levetiracetam Sun. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam Sun.
Authorisation details
Product details | |
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Name |
Levetiracetam Sun
|
Agency product number |
EMEA/H/C/002051
|
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 | |
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Marketing-authorisation holder |
Sun Pharmaceutical Industries Europe B.V.
|
Revision |
19
|
Date of issue of marketing authorisation valid throughout the European Union |
14/12/2011
|
Contact address |
Polarisavenue 87 |
Product information
19/09/2023 Levetiracetam Sun - EMEA/H/C/002051 - IB/0030
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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
Therapeutic indication
Levetiracetam Sun 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 Sun is indicated as adjunctive therapy:
- in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four 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 Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.