{"id":22417,"date":"2026-10-27T16:19:47","date_gmt":"2026-10-27T16:19:47","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=22417"},"modified":"2026-10-27T16:19:47","modified_gmt":"2026-10-27T16:19:47","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-brimica-genuair-aclidinium-formoterol-fumarate-dihydrate-date-dautorisation-19-11-2014-revision","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=22417","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Brimica Genuair, aclidinium, formot\u00e9rol fumarate dihydrat\u00e9, Date d\u2019autorisation : 19\/11\/2014, R\u00e9vision : 17, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Brimica Genuair est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte pour le traitement symptomatique d\u2019entretien de la bronchopneumopathie chronique obstructive (BPCO), une maladie chronique caract\u00e9ris\u00e9e par une atteinte des voies a\u00e9riennes et des alv\u00e9oles entra\u00eenant des difficult\u00e9s respiratoires. Le m\u00e9dicament est disponible dans l\u2019Union europ\u00e9enne sous forme de poudre pour inhalation administr\u00e9e par un dispositif portatif, d\u00e9livr\u00e9 uniquement sur prescription m\u00e9dicale.<\/p>\n<p>Brimica Genuair associe deux principes actifs : le bromure d\u2019aclidinium et le fumarate de formot\u00e9rol dihydrat\u00e9. Chaque inhalation d\u00e9livre 340 microgrammes d\u2019aclidinium et 12 microgrammes de formot\u00e9rol. La posologie recommand\u00e9e est d\u2019une inhalation deux fois par jour. L\u2019utilisation correcte de l\u2019inhalateur fait l\u2019objet d\u2019instructions sp\u00e9cifiques dans la notice.<\/p>\n<p>Les deux substances agissent en maintenant les voies respiratoires ouvertes afin de faciliter la respiration. L\u2019aclidinium est un antagoniste muscarinique de longue dur\u00e9e d\u2019action qui bloque certains r\u00e9cepteurs muscariniques dans les cellules musculaires des poumons, provoquant la relaxation des muscles des voies a\u00e9riennes. Le formot\u00e9rol est un agoniste b\u00eata-2 de longue dur\u00e9e d\u2019action qui se fixe sur les r\u00e9cepteurs b\u00eata-2 des muscles bronchiques et entra\u00eene leur relaxation. Les antagonistes muscariniques de longue dur\u00e9e d\u2019action et les agonistes b\u00eata-2 de longue dur\u00e9e d\u2019action sont couramment associ\u00e9s dans la prise en charge de la BPCO. L\u2019aclidinium est d\u00e9j\u00e0 autoris\u00e9 dans l\u2019UE sous les noms Bretaris Genuair et Eklira Genuair depuis juillet 2012, et le formot\u00e9rol est commercialis\u00e9 dans l\u2019UE depuis les ann\u00e9es 1990.<\/p>\n<p>L\u2019efficacit\u00e9 de Brimica Genuair a \u00e9t\u00e9 \u00e9valu\u00e9e dans deux \u00e9tudes principales portant sur plus de 3 400 patients atteints de BPCO, comparativement \u00e0 l\u2019aclidinium seul, au formot\u00e9rol seul et \u00e0 un placebo. Le crit\u00e8re principal portait sur l\u2019\u00e9volution du volume expiratoire maximal par seconde (VEMS, FEV1) apr\u00e8s six mois de traitement. Une heure apr\u00e8s l\u2019inhalation, l\u2019augmentation du VEMS \u00e9tait sup\u00e9rieure de 293 ml avec Brimica Genuair par rapport au placebo et de 118 ml par rapport \u00e0 l\u2019aclidinium seul. L\u2019am\u00e9lioration par rapport au formot\u00e9rol seul \u00e9tait faible et jug\u00e9e non cliniquement significative, avec un VEMS mesur\u00e9 le matin avant l\u2019inhalation sup\u00e9rieur de 68 ml avec Brimica Genuair. Le m\u00e9dicament a \u00e9galement augment\u00e9 la proportion de patients pr\u00e9sentant une am\u00e9lioration de la dyspn\u00e9e par rapport au placebo. Les effets ind\u00e9sirables ne sont pas d\u00e9taill\u00e9s dans la source. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/brimica-genuair\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Brimica Genuair est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte pour le traitement symptomatique d\u2019entretien de la bronchopneumopathie chronique obstructive (BPCO), une maladie chronique caract\u00e9ris\u00e9e par une atteinte des voies a\u00e9riennes et [&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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