Le 17 septembre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a \u00e9mis un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 pour Ruxolitinib Zentiva, m\u00e9dicament g\u00e9n\u00e9rique destin\u00e9 au traitement de certaines h\u00e9mopathies malignes et de la r\u00e9action du greffon contre l\u2019h\u00f4te (GvHD). Le demandeur est l\u2019entreprise Zentiva k.s. <\/p>\n
Ruxolitinib Zentiva sera disponible sous forme de comprim\u00e9s dos\u00e9s \u00e0 5 mg, 10 mg, 15 mg et 20 mg. La substance active est le ruxolitinib, inhibiteur de prot\u00e9ine kinase (code ATC L01EJ01) dont l\u2019activit\u00e9 antin\u00e9oplasique est li\u00e9e \u00e0 l\u2019inhibition s\u00e9lective des kinases JAK impliqu\u00e9es dans les voies de signalisation de diverses cytokines et facteurs de croissance, importants pour l\u2019h\u00e9matopo\u00ef\u00e8se et la fonction immunitaire. <\/p>\n
Ruxolitinib Zentiva est un g\u00e9n\u00e9rique de Jakavi, autoris\u00e9 dans l\u2019Union europ\u00e9enne depuis le 23 ao\u00fbt 2012. Les \u00e9tudes ont d\u00e9montr\u00e9 une qualit\u00e9 jug\u00e9e satisfaisante et la bio\u00e9quivalence avec le m\u00e9dicament de r\u00e9f\u00e9rence. <\/p>\n
Les indications retenues par le CHMP couvrent trois grands domaines. Pour la my\u00e9lofibrose, Ruxolitinib Zentiva est indiqu\u00e9 dans le traitement de la spl\u00e9nom\u00e9galie li\u00e9e \u00e0 la maladie ou des sympt\u00f4mes chez l\u2019adulte pr\u00e9sentant une my\u00e9lofibrose primitive (my\u00e9lofibrose idiopathique chronique), une my\u00e9lofibrose post-polyglobulie vraie ou une my\u00e9lofibrose post-thrombocyt\u00e9mie essentielle. Pour la polyglobulie vraie, il est indiqu\u00e9 chez l\u2019adulte r\u00e9sistant ou intol\u00e9rant \u00e0 l\u2019hydroxyur\u00e9e. <\/p>\n
Pour la r\u00e9action du greffon contre l\u2019h\u00f4te, Ruxolitinib Zentiva est indiqu\u00e9, en cas de r\u00e9ponse insuffisante aux cortico\u00efdes ou \u00e0 d\u2019autres traitements syst\u00e9miques, chez les adultes et les patients p\u00e9diatriques \u00e0 partir de 28 jours pour la forme aigu\u00eb, et chez les adultes et les patients p\u00e9diatriques \u00e0 partir de 6 mois pour la forme chronique. <\/p>\n
Le traitement par Ruxolitinib Zentiva doit \u00eatre initi\u00e9 par un m\u00e9decin exp\u00e9riment\u00e9 dans l\u2019administration de m\u00e9dicaments anticanc\u00e9reux. Les recommandations d\u00e9taill\u00e9es d\u2019utilisation figureront dans le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit, qui sera publi\u00e9 dans toutes les langues officielles de l\u2019Union europ\u00e9enne apr\u00e8s la d\u00e9cision finale de la Commission europ\u00e9enne sur l\u2019autorisation de mise sur le march\u00e9. <\/p>\n
Cette d\u00e9cision du CHMP s\u2019inscrit dans le cadre de la r\u00e9glementation europ\u00e9enne applicable aux m\u00e9dicaments g\u00e9n\u00e9riques, qui doivent contenir la m\u00eame substance active que le m\u00e9dicament de r\u00e9f\u00e9rence, \u00eatre utilis\u00e9s aux m\u00eames doses et pour les m\u00eames indications. Elle pr\u00e9sente un int\u00e9r\u00eat pour le suivi des politiques pharmaceutiques, notamment en mati\u00e8re d\u2019acc\u00e8s aux traitements on\u00e9reux d\u2019onco-h\u00e9matologie et de GvHD, et de d\u00e9veloppement de g\u00e9n\u00e9riques au niveau europ\u00e9en. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 17 septembre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a \u00e9mis un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur le […]<\/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-17905","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\/17905","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=17905"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17905\/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=17905"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17905"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17905"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}