Zonisamide Mylan
zonisamide
Table of contents
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.
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Zonisamide Mylan : EPAR - Summary for the public (PDF/98.33 KB)
First published: 06/04/2016
Last updated: 06/04/2016 -
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Zonisamide Mylan : EPAR - Risk-management-plan summary (PDF/101.35 KB)
First published: 06/04/2016
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 | |
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Marketing-authorisation holder |
Mylan Pharmaceuticals Limited
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
31/03/2016
|
Contact address |
Mylan Pharmaceuticals Limited |
Product information
07/06/2023 Zonisamide Mylan - EMEA/H/C/004127 - IB/0013
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
- 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.