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.
Zonegran : EPAR - Summary for the public (PDF/57.39 KB)
First published: 15/05/2008
Last updated: 18/10/2013
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21/09/2018 Zonegran - EMEA/H/C/000577 - T/0090
- 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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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.