Zonegran
zonisamide
Table of contents
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 10/05/2019
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 |
30
|
Date of issue of marketing authorisation valid throughout the European Union |
10/03/2005
|
Product information
19/02/2019 Zonegran - EMEA/H/C/000577 - IB/0093
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Anti epileptics
Therapeutic indication
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.