Zonegran

RSS

zonisamide

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

Overview

This is a summary of the European public assessment report (EPAR) for Zonegran. 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 Zonegran.

This EPAR was last updated on 08/10/2018

Authorisation details

Product details
Name
Zonegran
Agency product number
EMEA/H/C/000577
Active substance
zonisamide
International non-proprietary name (INN) or common name
zonisamide
Therapeutic area (MeSH)
Epilepsies, Partial
Anatomical therapeutic chemical (ATC) code
N03AX15
Publication details
Marketing-authorisation holder
Eisai GmbH
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
10/03/2005

Product information

21/09/2018 Zonegran - EMEA/H/C/000577 - T/0090

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Anti epileptics

Therapeutic indication

Zonegran is indicated as:

  • monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
  • adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.

Assessment history

Changes since initial authorisation of medicine

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