{"id":17728,"date":"2026-09-15T14:06:16","date_gmt":"2026-09-15T14:06:16","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=17728"},"modified":"2026-09-15T14:06:16","modified_gmt":"2026-09-15T14:06:16","slug":"rapport-europeen-public-devaluation-des-medicaments-a-usage-humain-epar-camcevi-leuproreline-date-dautorisation-24-05-2022-revision-7-statut-autorise-titre-tradui","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=17728","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation des m\u00e9dicaments \u00e0 usage humain (EPAR) : Camcevi, leupror\u00e9line, Date d\u2019autorisation : 24\/05\/2022, R\u00e9vision : 7, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Camcevi est un m\u00e9dicament destin\u00e9 au traitement du cancer de la prostate hormono-d\u00e9pendant chez l\u2019homme adulte. Il est utilis\u00e9 pour les formes avanc\u00e9es ainsi qu\u2019en association \u00e0 une radioth\u00e9rapie dans les cancers de la prostate localement avanc\u00e9s hormono-d\u00e9pendants et dans les cancers localis\u00e9s \u00e0 haut risque d\u2019extension locale. Le m\u00e9dicament contient comme substance active le leupror\u00e9line, d\u00e9j\u00e0 utilis\u00e9 dans d\u2019autres sp\u00e9cialit\u00e9s de r\u00e9f\u00e9rence.<\/p>\n<p>Camcevi est un m\u00e9dicament dit \u00ab hybride \u00bb, c\u2019est-\u00e0-dire similaire \u00e0 un m\u00e9dicament de r\u00e9f\u00e9rence contenant la m\u00eame substance active, ici Eligard, mais avec une formulation diff\u00e9rente. Contrairement \u00e0 Eligard, qui n\u00e9cessite un pr\u00e9m\u00e9lange avant administration, Camcevi est disponible sous forme de suspension \u00e0 lib\u00e9ration prolong\u00e9e pr\u00eate \u00e0 l\u2019emploi en seringue pr\u00e9remplie. L\u2019injection est administr\u00e9e sous la peau, sous la responsabilit\u00e9 d\u2019un professionnel de sant\u00e9 exp\u00e9riment\u00e9 dans le traitement du cancer de la prostate et sous la supervision d\u2019un m\u00e9decin.<\/p>\n<p>Le produit est \u00e0 obtention exclusivement sur prescription m\u00e9dicale. Une injection forme un gel sous-cutan\u00e9 qui lib\u00e8re progressivement la substance active sur une dur\u00e9e de six mois. Le m\u00e9canisme d\u2019action repose sur la r\u00e9duction de la testost\u00e9rone, hormone favorisant la croissance des cellules canc\u00e9reuses prostatiques. Leupror\u00e9line bloque l\u2019action de l\u2019hormone naturelle GnRH, premi\u00e8re \u00e9tape de la cha\u00eene de production de la testost\u00e9rone, ce qui entra\u00eene une baisse durable du taux de testost\u00e9rone et un ralentissement de la croissance tumorale.<\/p>\n<p>Les donn\u00e9es d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 proviennent de la litt\u00e9rature publi\u00e9e sur le leupror\u00e9line dans les indications approuv\u00e9es, compl\u00e9t\u00e9es par des \u00e9tudes de qualit\u00e9 pharmaceutique propres \u00e0 Camcevi. Une \u00e9tude clinique sp\u00e9cifique a \u00e9t\u00e9 pr\u00e9sent\u00e9e : 137 hommes atteints de cancer de la prostate hormono-d\u00e9pendant ont re\u00e7u deux injections de Camcevi espac\u00e9es de 24 semaines. Quatre semaines apr\u00e8s la premi\u00e8re injection, 98,5 % des patients (135\/137) pr\u00e9sentaient un taux de testost\u00e9rone r\u00e9duit \u00e0 un niveau comparable \u00e0 celui observ\u00e9 apr\u00e8s castration chimique ou chirurgicale. Ce taux est rest\u00e9 en dessous du seuil de castration pendant les 48 semaines de suivi chez 97 % des patients (133\/137).<\/p>\n<p>L\u2019effet ind\u00e9sirable le plus fr\u00e9quent, touchant plus d\u2019un patient sur deux, est la survenue de bouff\u00e9es de chaleur, g\u00e9n\u00e9ralement d\u2019intensit\u00e9 l\u00e9g\u00e8re \u00e0 mod\u00e9r\u00e9e. Aucune autre donn\u00e9e chiffr\u00e9e de tol\u00e9rance n\u2019est d\u00e9taill\u00e9e. Les informations pratiques suppl\u00e9mentaires sur l\u2019utilisation du m\u00e9dicament rel\u00e8vent de la notice et de l\u2019avis du m\u00e9decin ou du pharmacien. Aucun pays ni autorit\u00e9 sanitaire sp\u00e9cifique n\u2019est explicitement mentionn\u00e9 dans la source, mais le contenu est de nature r\u00e9glementaire et clinique et pr\u00e9sente un int\u00e9r\u00eat pour le suivi des options th\u00e9rapeutiques disponibles pour le cancer de la prostate hormono-d\u00e9pendant, notamment l\u2019apport d\u2019une forme \u00e0 lib\u00e9ration prolong\u00e9e semestrielle pr\u00eate \u00e0 l\u2019emploi. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/camcevi\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Camcevi est un m\u00e9dicament destin\u00e9 au traitement du cancer de la prostate hormono-d\u00e9pendant chez l\u2019homme adulte. Il est utilis\u00e9 pour les formes avanc\u00e9es ainsi qu\u2019en association \u00e0 une radioth\u00e9rapie dans [&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-17728","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\/17728","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=17728"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17728\/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=17728"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17728"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17728"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}