{"id":21555,"date":"2026-10-20T10:49:16","date_gmt":"2026-10-20T10:49:16","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21555"},"modified":"2026-10-20T10:49:16","modified_gmt":"2026-10-20T10:49:16","slug":"evaluation-europeenne-publique-des-medicaments-a-usage-humain-epar-cabazitaxel-accord-cabazitaxel-date-dautorisation-28-08-2020-revision-8-statut-autorise-titre-traduit-en","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21555","title":{"rendered":"\u00c9valuation europ\u00e9enne publique des m\u00e9dicaments \u00e0 usage humain (EPAR) : Cabazitaxel Accord, cabazitaxel, Date d\u2019autorisation : 28\/08\/2020, R\u00e9vision : 8, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Cabazitaxel Accord est un m\u00e9dicament anticanc\u00e9reux destin\u00e9 au traitement des hommes atteints d\u2019un cancer de la prostate m\u00e9tastatique r\u00e9sistant \u00e0 la castration. Il est indiqu\u00e9 lorsque la maladie s\u2019est propag\u00e9e \u00e0 d\u2019autres parties du corps malgr\u00e9 des traitements visant \u00e0 supprimer la production de testost\u00e9rone ou apr\u00e8s castration chirurgicale, et chez des patients d\u00e9j\u00e0 trait\u00e9s par doc\u00e9taxel. Il est administr\u00e9 en association avec la prednisone ou la prednisolone, prises quotidiennement pendant toute la dur\u00e9e du traitement.<\/p>\n<p>Ce m\u00e9dicament contient du cabazitaxel et est pr\u00e9sent\u00e9 comme un m\u00e9dicament \u00ab hybride \u00bb et \u00ab g\u00e9n\u00e9rique \u00bb du m\u00e9dicament de r\u00e9f\u00e9rence Jevtana, contenant la m\u00eame substance active mais \u00e0 une concentration diff\u00e9rente et avec un mode de pr\u00e9paration (dilution) distinct. Les \u00e9tudes d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 sp\u00e9cifiques au cabazitaxel dans cette indication ont d\u00e9j\u00e0 \u00e9t\u00e9 r\u00e9alis\u00e9es avec le m\u00e9dicament de r\u00e9f\u00e9rence, et n\u2019ont pas \u00e9t\u00e9 r\u00e9p\u00e9t\u00e9es pour Cabazitaxel Accord. Le fabricant a fourni des donn\u00e9es sur la qualit\u00e9 pharmaceutique du produit ; des \u00e9tudes de bio\u00e9quivalence n\u2019ont pas \u00e9t\u00e9 jug\u00e9es n\u00e9cessaires.<\/p>\n<p>Cabazitaxel Accord ne peut \u00eatre obtenu que sur prescription m\u00e9dicale et doit \u00eatre utilis\u00e9 exclusivement dans des structures sp\u00e9cialis\u00e9es en chimioth\u00e9rapie, sous la supervision de m\u00e9decins exp\u00e9riment\u00e9s dans l\u2019usage de ces traitements. Il est disponible sous forme de concentr\u00e9 \u00e0 diluer pour perfusion intraveineuse. La perfusion, d\u2019une dur\u00e9e d\u2019une heure, est administr\u00e9e toutes les trois semaines \u00e0 une posologie calcul\u00e9e en fonction du poids et de la taille du patient. Avant chaque perfusion, des m\u00e9dicaments de pr\u00e9vention des r\u00e9actions allergiques et des vomissements doivent \u00eatre administr\u00e9s.<\/p>\n<p>Des adaptations de dose ou un arr\u00eat du traitement peuvent \u00eatre n\u00e9cessaires en cas d\u2019effets ind\u00e9sirables. Une r\u00e9duction de dose est recommand\u00e9e chez les patients pr\u00e9sentant une atteinte h\u00e9patique l\u00e9g\u00e8re, tandis que le m\u00e9dicament est contre-indiqu\u00e9 en cas d\u2019atteinte h\u00e9patique mod\u00e9r\u00e9e ou s\u00e9v\u00e8re. Le m\u00e9canisme d\u2019action du cabazitaxel, appartenant \u00e0 la classe des taxanes, repose sur le blocage de la d\u00e9gradation du \u00ab squelette \u00bb interne des cellules canc\u00e9reuses, ce qui emp\u00eache leur division et conduit \u00e0 leur mort. Le m\u00e9dicament peut \u00e9galement affecter des cellules non canc\u00e9reuses, notamment sanguines et nerveuses, ce qui est \u00e0 l\u2019origine de certains effets ind\u00e9sirables.<\/p>\n<p>Les principaux acteurs mentionn\u00e9s sont l\u2019entreprise pharmaceutique titulaire de l\u2019autorisation (non nomm\u00e9e dans la source) et le m\u00e9dicament de r\u00e9f\u00e9rence Jevtana, d\u00e9j\u00e0 autoris\u00e9 pour la m\u00eame utilisation. Les informations fournies rel\u00e8vent du cadre europ\u00e9en d\u2019autorisation des m\u00e9dicaments, sans pr\u00e9cision de pays au-del\u00e0 de ce contexte. Les enjeux potentiels pour les politiques de sant\u00e9 concernent principalement l\u2019acc\u00e8s \u00e0 une alternative g\u00e9n\u00e9rique\/hybride dans le traitement du cancer de la prostate m\u00e9tastatique r\u00e9sistant, les conditions d\u2019utilisation s\u00e9curis\u00e9e en milieu sp\u00e9cialis\u00e9 et les restrictions li\u00e9es \u00e0 la fonction h\u00e9patique. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/cabazitaxel-accord\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Cabazitaxel Accord est un m\u00e9dicament anticanc\u00e9reux destin\u00e9 au traitement des hommes atteints d\u2019un cancer de la prostate m\u00e9tastatique r\u00e9sistant \u00e0 la castration. Il est indiqu\u00e9 lorsque la maladie s\u2019est propag\u00e9e [&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-21555","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\/21555","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=21555"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21555\/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=21555"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21555"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21555"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}