{"id":18237,"date":"2026-09-22T13:46:18","date_gmt":"2026-09-22T13:46:18","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=18237"},"modified":"2026-09-22T13:46:18","modified_gmt":"2026-09-22T13:46:18","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-zokovea-ensitrelvir-date-dautorisation-18-09-2026-statut-autorise-titre-traduit-en-franc","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=18237","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Zokovea, ensitrelvir, Date d\u2019autorisation : 18\/09\/2026, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Le document pr\u00e9sente Zokovea, un m\u00e9dicament antiviral \u00e0 base d\u2019ensitrelvir destin\u00e9 \u00e0 la pr\u00e9vention post-exposition de la COVID-19 chez les adultes et les adolescents de 12 ans et plus ayant \u00e9t\u00e9 expos\u00e9s au SARS-CoV-2. Le traitement se pr\u00e9sente sous forme de comprim\u00e9s pris une fois par jour pendant cinq jours et doit \u00eatre initi\u00e9 dans les trois jours suivant un contact \u00e9troit avec une personne infect\u00e9e. Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale et son utilisation est d\u00e9taill\u00e9e dans le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit et la notice.<\/p>\n<p>L\u2019ensitrelvir agit en inhibant la prot\u00e9ase 3C-like du SARS-CoV-2, prot\u00e9ine n\u00e9cessaire \u00e0 la r\u00e9plication virale, ce qui r\u00e9duit la probabilit\u00e9 de d\u00e9veloppement d\u2019une infection symptomatique. Une \u00e9tude principale portant sur 2 387 personnes vivant avec une personne atteinte de COVID-19 a montr\u00e9 une diminution de l\u2019incidence de la maladie symptomatique : dans les 10 jours suivant la premi\u00e8re prise, 3 % des personnes trait\u00e9es par Zokovea ont d\u00e9velopp\u00e9 une COVID-19 symptomatique, contre 9 % dans le groupe placebo.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents (jusqu\u2019\u00e0 1 personne sur 10) sont une augmentation des triglyc\u00e9rides sanguins, des c\u00e9phal\u00e9es, des diarrh\u00e9es et des naus\u00e9es, g\u00e9n\u00e9ralement d\u2019intensit\u00e9 l\u00e9g\u00e8re \u00e0 mod\u00e9r\u00e9e et se r\u00e9solvant en quelques jours. Zokovea est contre-indiqu\u00e9 chez la femme enceinte. Il ne doit pas \u00eatre utilis\u00e9 chez les personnes recevant des m\u00e9dicaments \u00e9limin\u00e9s par l\u2019enzyme CYP3A lorsque des concentrations \u00e9lev\u00e9es de ces m\u00e9dicaments peuvent entra\u00eener des cons\u00e9quences graves ou vitales, ni chez les patients prenant des inducteurs du CYP3A susceptibles de diminuer l\u2019efficacit\u00e9 du traitement. Les pr\u00e9cisions sur ces interactions figurent dans la notice.<\/p>\n<p>L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a conclu que le rapport b\u00e9n\u00e9fice\/risque de Zokovea est favorable pour la pr\u00e9vention de la COVID-19 chez les personnes expos\u00e9es au SARS-CoV-2 et a autoris\u00e9 sa mise sur le march\u00e9 dans l\u2019ensemble de l\u2019Union europ\u00e9enne le 18 septembre 2026. Des recommandations sp\u00e9cifiques pour les professionnels de sant\u00e9 et les patients sont incluses dans le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit et la notice. Comme pour tous les m\u00e9dicaments, les donn\u00e9es de pharmacovigilance sont suivies en continu par les autorit\u00e9s comp\u00e9tentes, les effets ind\u00e9sirables suspect\u00e9s faisant l\u2019objet d\u2019une \u00e9valuation et, le cas \u00e9ch\u00e9ant, de mesures correctrices pour la protection des patients. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/zokovea\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Le document pr\u00e9sente Zokovea, un m\u00e9dicament antiviral \u00e0 base d\u2019ensitrelvir destin\u00e9 \u00e0 la pr\u00e9vention post-exposition de la COVID-19 chez les adultes et les adolescents de 12 ans et plus ayant [&hellip;]<\/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-18237","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\/18237","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=18237"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18237\/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=18237"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18237"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18237"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}