Zonisamide Mylan

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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 Zonisamide Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zonisamide Mylan.

For practical information about using Zonisamide Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 09/08/2018

Authorisation details

Product details
Name
Zonisamide Mylan
Agency product number
EMEA/H/C/004127
Active substance
zonisamide
International non-proprietary name (INN) or common name
zonisamide
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX15
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
Mylan S.A.S.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
30/03/2016
Contact address
117 Allée des Parcs
69800 Saint Priest
France

Product information

26/03/2018 Zonisamide Mylan - EMEA/H/C/004127 - IB/0004

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

Antiepileptics

Therapeutic indication

  • 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 6 years and above.

Assessment history

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