{"id":22418,"date":"2026-10-27T16:19:47","date_gmt":"2026-10-27T16:19:47","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=22418"},"modified":"2026-10-27T16:19:47","modified_gmt":"2026-10-27T16:19:47","slug":"rapport-public-europeen-devaluation-epar-pour-les-medicaments-a-usage-humain-bretaris-genuair-bromure-daclidinium-date-dautorisation-20-07-2012-revision-21-statu","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=22418","title":{"rendered":"Rapport public europ\u00e9en d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Bretaris Genuair, bromure d\u2019aclidinium, date d\u2019autorisation : 20\/07\/2012, r\u00e9vision : 21, statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Bretaris Genuair est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte pour le traitement d\u2019entretien de la bronchopneumopathie chronique obstructive (BPCO), pathologie respiratoire chronique caract\u00e9ris\u00e9e par une obstruction des voies a\u00e9riennes entra\u00eenant une g\u00eane respiratoire. Il contient comme substance active le bromure d\u2019aclidinium, un bronchodilatateur antimuscarinique qui agit en bloquant les r\u00e9cepteurs muscariniques, ce qui induit une relaxation des muscles des voies respiratoires, facilite l\u2019ouverture des bronches et am\u00e9liore la respiration.<\/p>\n<p>Le m\u00e9dicament est disponible sous forme de poudre pour inhalation administr\u00e9e par un dispositif portable. Chaque inhalation d\u00e9livre 375 microgrammes de bromure d\u2019aclidinium, correspondant \u00e0 322 microgrammes d\u2019aclidinium. La posologie recommand\u00e9e est d\u2019une inhalation deux fois par jour. Bretaris Genuair est soumis \u00e0 prescription m\u00e9dicale.<\/p>\n<p>L\u2019efficacit\u00e9 de Bretaris Genuair a \u00e9t\u00e9 \u00e9valu\u00e9e dans une \u00e9tude principale incluant 828 patients atteints de BPCO, comparant deux doses (200 et 400 microgrammes, deux fois par jour) \u00e0 un placebo. Le crit\u00e8re principal \u00e9tait l\u2019am\u00e9lioration du volume expiratoire maximal en une seconde (VEMS, FEV1). Apr\u00e8s six mois de traitement, l\u2019augmentation moyenne du VEMS par rapport au placebo \u00e9tait de 99 ml pour la dose de 200 microgrammes et de 128 ml pour la dose de 400 microgrammes, cette derni\u00e8re correspondant \u00e0 une inhalation d\u00e9livrant 322 microgrammes d\u2019aclidinium. Les b\u00e9n\u00e9fices cliniques sont d\u00e9crits comme maintenus jusqu\u2019\u00e0 un an.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents (plus de 5 % des patients) sont les c\u00e9phal\u00e9es et la rhinopharyngite. D\u2019autres effets fr\u00e9quents (plus de 1 % des patients) sont la sinusite, la toux, les naus\u00e9es et la diarrh\u00e9e. Les effets ind\u00e9sirables sont jug\u00e9s r\u00e9versibles et d\u2019un profil similaire \u00e0 celui des autres bronchodilatateurs antimuscariniques. Le texte souligne que ces m\u00e9dicaments peuvent avoir un effet sur le c\u0153ur et les vaisseaux sanguins, ce qui justifie une surveillance attentive de la part du titulaire de l\u2019autorisation.<\/p>\n<p>Le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a consid\u00e9r\u00e9 que Bretaris Genuair apporte une am\u00e9lioration significative des sympt\u00f4mes de la BPCO, avec un profil de s\u00e9curit\u00e9 sans signal majeur. Il a conclu que le rapport b\u00e9n\u00e9fice\/risque est favorable et a recommand\u00e9 l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9. Ces \u00e9l\u00e9ments s\u2019inscrivent dans le cadre de l\u2019\u00e9valuation europ\u00e9enne des traitements de la BPCO, pathologie \u00e0 forte pr\u00e9valence et impact fonctionnel important, avec des implications potentielles pour l\u2019organisation des soins respiratoires et la prise en charge de la maladie chronique. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/bretaris-genuair\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Bretaris Genuair est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte pour le traitement d\u2019entretien de la bronchopneumopathie chronique obstructive (BPCO), pathologie respiratoire chronique caract\u00e9ris\u00e9e par une obstruction des voies a\u00e9riennes entra\u00eenant une [&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 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