Levetiracetam Accord

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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 Accord. 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 Accord.

This EPAR was last updated on 13/01/2022

Authorisation details

Product details
Name
Levetiracetam Accord
Agency product number
EMEA/H/C/002290
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
Accord Healthcare S.L.U.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
03/10/2011
Contact address

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona
SPAIN

Product information

10/01/2022 Levetiracetam Accord - EMEA/H/C/002290 - IA/0037

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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

Antiepileptics

Therapeutic indication

Levetiracetam 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 is indicated as adjunctive therapy:

  • in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one 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.

Assessment history

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