Levetiracetam Sun

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levetiracetam

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

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.

This EPAR was last updated on 22/09/2023

Authorisation details

Product details
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
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
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
2132 JH Hoofddorp
The Netherlands

Product information

19/09/2023 Levetiracetam Sun - EMEA/H/C/002051 - IB/0030

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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

Other antiepileptics

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.

Assessment history

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