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.
Zonisamide Mylan : EPAR - Summary for the public (PDF/98.33 KB)
First published: 06/04/2016
Last updated: 06/04/2016
Zonisamide Mylan : EPAR - Risk-management-plan summary
First published: 25/01/2016
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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.
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117 Allée des Parcs
69800 Saint Priest
01/12/2020 Zonisamide Mylan - EMEA/H/C/004127 - R/0008
- 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.
- 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.