Le document pr\u00e9sente Zonisamide Viatris, un m\u00e9dicament g\u00e9n\u00e9rique contenant la substance active zonisamide, indiqu\u00e9 dans le traitement des crises partielles d\u2019\u00e9pilepsie, avec ou sans g\u00e9n\u00e9ralisation secondaire. Il est destin\u00e9 aux adultes nouvellement diagnostiqu\u00e9s en monoth\u00e9rapie, ainsi qu\u2019en traitement adjuvant chez l\u2019adulte et chez l\u2019enfant \u00e0 partir de 6 ans d\u00e9j\u00e0 trait\u00e9s par d\u2019autres anti\u00e9pileptiques. Le m\u00e9dicament est disponible dans l\u2019Union europ\u00e9enne uniquement sur prescription m\u00e9dicale, sous forme de g\u00e9lules, avec une posologie adapt\u00e9e au type de patient (adulte ou enfant) et au sch\u00e9ma th\u00e9rapeutique (monoth\u00e9rapie ou traitement adjuvant, d\u00e9tails renvoy\u00e9s \u00e0 la notice et au prescripteur).<\/p>\n
Zonisamide Viatris est qualifi\u00e9 de m\u00e9dicament g\u00e9n\u00e9rique de Zonegran, m\u00e9dicament de r\u00e9f\u00e9rence d\u00e9j\u00e0 autoris\u00e9 dans l\u2019UE. Des \u00e9tudes de qualit\u00e9 pharmaceutique et de bio\u00e9quivalence ont \u00e9t\u00e9 fournies par l\u2019entreprise titulaire, montrant que Zonisamide Viatris conduit \u00e0 des niveaux de substance active dans l\u2019organisme comparables \u00e0 ceux du m\u00e9dicament de r\u00e9f\u00e9rence et est donc attendu comme ayant les m\u00eames effets cliniques. Les \u00e9tudes d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 d\u00e9j\u00e0 r\u00e9alis\u00e9es pour Zonegran dans les indications autoris\u00e9es n\u2019ont pas \u00e9t\u00e9 reproduites, conform\u00e9ment au cadre applicable aux g\u00e9n\u00e9riques.<\/p>\n
Sur le plan pharmacologique, la zonisamide est pr\u00e9sent\u00e9e comme un anti\u00e9pileptique agissant principalement par blocage de certains canaux sodiques et calciques au niveau des neurones, ce qui limite la propagation de l\u2019activit\u00e9 \u00e9lectrique anormale \u00e0 l\u2019origine des crises. Le texte indique \u00e9galement une action sur le neurotransmetteur GABA, contribuant \u00e0 la stabilisation de l\u2019activit\u00e9 \u00e9lectrique c\u00e9r\u00e9brale.<\/p>\n
L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) conclut que Zonisamide Viatris r\u00e9pond aux exigences europ\u00e9ennes en termes de qualit\u00e9 et de bio\u00e9quivalence par rapport \u00e0 Zonegran. Elle consid\u00e8re, sur cette base, que le profil b\u00e9n\u00e9fices\/risques est \u00e9quivalent \u00e0 celui du m\u00e9dicament de r\u00e9f\u00e9rence et que l\u2019autorisation de mise sur le march\u00e9 dans l\u2019UE est justifi\u00e9e. Des recommandations et pr\u00e9cautions \u00e0 destination des professionnels de sant\u00e9 et des patients sont int\u00e9gr\u00e9es dans la documentation officielle afin de garantir un usage s\u00fbr et efficace, sans que le d\u00e9tail de ces mesures ne soit pr\u00e9cis\u00e9 dans le document. Ces \u00e9l\u00e9ments s\u2019inscrivent dans le cadre europ\u00e9en de r\u00e9gulation des g\u00e9n\u00e9riques, pertinent pour le suivi des politiques du m\u00e9dicament et de l\u2019acc\u00e8s aux traitements anti\u00e9pileptiques. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente Zonisamide Viatris, un m\u00e9dicament g\u00e9n\u00e9rique contenant la substance active zonisamide, indiqu\u00e9 dans le traitement des crises partielles d\u2019\u00e9pilepsie, avec ou sans g\u00e9n\u00e9ralisation secondaire. Il est destin\u00e9 aux […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-17730","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17730","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=17730"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17730\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17730"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17730"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17730"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}