{"id":19715,"date":"2026-10-02T08:57:11","date_gmt":"2026-10-02T08:57:11","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=19715"},"modified":"2026-10-02T08:57:11","modified_gmt":"2026-10-02T08:57:11","slug":"rapport-public-europeen-devaluation-epar-pour-les-medicaments-a-usage-humain-riltrava-aerosphere-fumarate-de-formoterol-dihydrate-glycopyrronium-budesonide-date-dautorisation","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=19715","title":{"rendered":"Rapport public europ\u00e9en d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Riltrava Aerosphere, fumarate de formot\u00e9rol dihydrat\u00e9, glycopyrronium, bud\u00e9sonide, date d\u2019autorisation : 06\/01\/2022, r\u00e9vision : 7, statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Riltrava Aerosphere est un m\u00e9dicament indiqu\u00e9 dans le traitement de la broncho-pneumopathie chronique obstructive (BPCO) et de l\u2019asthme. Il est destin\u00e9 au traitement de fond de la BPCO mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re chez l\u2019adulte lorsque la maladie n\u2019est pas suffisamment contr\u00f4l\u00e9e par une association inhal\u00e9e comprenant un b\u00eata-2 agoniste de longue dur\u00e9e d\u2019action et soit un cortico\u00efde inhal\u00e9, soit un antagoniste muscarinique de longue dur\u00e9e d\u2019action. Il est \u00e9galement indiqu\u00e9 chez les patients \u00e2g\u00e9s de 12 ans et plus pour le traitement de l\u2019asthme non suffisamment contr\u00f4l\u00e9 par une association inhal\u00e9e de cortico\u00efdes et de b\u00eata-2 agoniste de longue dur\u00e9e d\u2019action.<\/p>\n<p>Riltrava Aerosphere contient trois substances actives : le formot\u00e9rol (b\u00eata-2 agoniste de longue dur\u00e9e d\u2019action), le bromure de glycopyrronium (antagoniste muscarinique de longue dur\u00e9e d\u2019action) et le bud\u00e9sonide (cortico\u00efde \u00e0 effet anti-inflammatoire). Ces trois composants agissent de mani\u00e8re compl\u00e9mentaire pour rel\u00e2cher les muscles des voies a\u00e9riennes, maintenir l\u2019ouverture des bronches et r\u00e9duire l\u2019inflammation, afin d\u2019am\u00e9liorer la respiration dans la BPCO et l\u2019asthme.<\/p>\n<p>Ce m\u00e9dicament est identique \u00e0 Trixeo Aerosphere, d\u00e9j\u00e0 autoris\u00e9 dans l\u2019Union europ\u00e9enne. Le titulaire de l\u2019autorisation de Trixeo Aerosphere a donn\u00e9 son accord pour que les donn\u00e9es scientifiques existantes soient utilis\u00e9es pour Riltrava Aerosphere dans le cadre d\u2019une proc\u00e9dure de consentement \u00e9clair\u00e9, ce qui implique une r\u00e9utilisation des donn\u00e9es cliniques sans nouvel essai sp\u00e9cifique pour Riltrava.<\/p>\n<p>Riltrava Aerosphere est disponible uniquement sur prescription m\u00e9dicale, sous la forme d\u2019un dispositif inhalateur portable. La posologie recommand\u00e9e est de deux inhalations deux fois par jour (matin et soir). L\u2019apprentissage correct de la technique d\u2019inhalation par un professionnel de sant\u00e9 est explicitement requis. Les informations d\u00e9taill\u00e9es d\u2019utilisation rel\u00e8vent de la notice destin\u00e9e aux patients ou de l\u2019avis du m\u00e9decin ou du pharmacien.<\/p>\n<p>Pour la BPCO, deux \u00e9tudes principales portant sur plus de 10 000 patients atteints de BPCO mod\u00e9r\u00e9e \u00e0 tr\u00e8s s\u00e9v\u00e8re ont montr\u00e9 que Riltrava Aerosphere am\u00e9liore le VEMS (volume expiratoire maximal en une seconde) et r\u00e9duit le nombre d\u2019exacerbations. Ces donn\u00e9es soutiennent l\u2019efficacit\u00e9 du m\u00e9dicament comme traitement de fond. Les informations chiffr\u00e9es d\u00e9taill\u00e9es, les dates d\u2019autorisation et les r\u00e9sultats complets des essais ne sont pas pr\u00e9sent\u00e9s dans l\u2019extrait disponible.<\/p>\n<p>Les autorit\u00e9s europ\u00e9ennes du m\u00e9dicament sont implicitement impliqu\u00e9es en tant qu\u2019entit\u00e9s d\u2019autorisation au niveau de l\u2019Union europ\u00e9enne, dans un cadre r\u00e9glementaire permettant la reconnaissance d\u2019un m\u00e9dicament \u00ab identique \u00bb via consentement \u00e9clair\u00e9. Cette configuration peut pr\u00e9senter un int\u00e9r\u00eat en termes de suivi des strat\u00e9gies th\u00e9rapeutiques combin\u00e9es pour la BPCO et l\u2019asthme, de surveillance de l\u2019usage des m\u00e9dicaments inhal\u00e9s triplement combin\u00e9s, et de comparaison des politiques de prise en charge des maladies respiratoires chroniques entre \u00c9tats membres. Les limitations de l\u2019information fournie incluent l\u2019absence de donn\u00e9es d\u00e9taill\u00e9es de tol\u00e9rance, de s\u00e9curit\u00e9, de co\u00fbt ou d\u2019impact organisationnel sur les syst\u00e8mes de sant\u00e9. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/riltrava-aerosphere\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Riltrava Aerosphere est un m\u00e9dicament indiqu\u00e9 dans le traitement de la broncho-pneumopathie chronique obstructive (BPCO) et de l\u2019asthme. Il est destin\u00e9 au traitement de fond de la BPCO mod\u00e9r\u00e9e \u00e0 [&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-19715","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\/19715","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=19715"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/19715\/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=19715"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=19715"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=19715"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}