{"id":21295,"date":"2026-10-16T13:38:36","date_gmt":"2026-10-16T13:38:36","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21295"},"modified":"2026-10-16T13:38:36","modified_gmt":"2026-10-16T13:38:36","slug":"rapport-europeen-public-devaluation-epar-des-medicaments-a-usage-humain-hyqvia-immunoglobuline-humaine-normale-date-dautorisation-16-05-2013-revision-27-statut-autorise","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21295","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) des m\u00e9dicaments \u00e0 usage humain : HyQvia, immunoglobuline humaine normale, Date d\u2019autorisation : 16\/05\/2013, R\u00e9vision : 27, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>HyQvia est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte et l\u2019enfant pr\u00e9sentant des syndromes d\u2019immunod\u00e9ficience, lorsque le sang ne contient pas une quantit\u00e9 suffisante d\u2019anticorps (immunoglobulines). Il est utilis\u00e9 dans les syndromes d\u2019immunod\u00e9ficience primitive (d\u00e9faut cong\u00e9nital de production d\u2019anticorps) et secondaire (d\u00e9ficit acquis de production d\u2019anticorps li\u00e9 \u00e0 une autre pathologie ou \u00e0 un traitement). Dans ces situations, HyQvia s\u2019adresse \u00e0 des patients ayant des infections graves ou r\u00e9currentes pour lesquelles les traitements en cours sont insuffisants et pr\u00e9sentant un taux sanguin bas d\u2019immunoglobuline G (IgG) ou une incapacit\u00e9 \u00e0 produire un niveau suffisant d\u2019IgG en r\u00e9ponse aux infections.<\/p>\n<p>HyQvia est \u00e9galement indiqu\u00e9 dans la polyradiculon\u00e9vrite inflammatoire d\u00e9my\u00e9linisante chronique (PIDC), apr\u00e8s stabilisation du patient sous immunoglobulines intraveineuses. Dans cette pathologie, un dysfonctionnement du syst\u00e8me immunitaire entra\u00eene la destruction de la gaine protectrice des nerfs et provoque des troubles neurologiques (faiblesse, engourdissements).<\/p>\n<p>Le m\u00e9dicament contient comme substance active une immunoglobuline humaine normale hautement purifi\u00e9e, extraite du sang, riche en IgG aux activit\u00e9s larges contre les agents infectieux. Il agit en r\u00e9tablissant les taux d\u2019IgG \u00e0 un niveau normal chez les patients d\u00e9ficitaires et en contribuant \u00e0 r\u00e9\u00e9quilibrer le fonctionnement du syst\u00e8me immunitaire dans la PIDC. HyQvia associe \u00e9galement une hyaluronidase humaine recombinante, enzyme facilitant la diffusion de l\u2019immunoglobuline sous la peau et am\u00e9liorant son absorption.<\/p>\n<p>HyQvia est soumis \u00e0 prescription m\u00e9dicale et son initiation ainsi que son suivi doivent \u00eatre assur\u00e9s par un m\u00e9decin exp\u00e9riment\u00e9 dans la prise en charge des immunod\u00e9ficiences ou de la PIDC. Il se pr\u00e9sente sous la forme de deux solutions pour perfusion sous-cutan\u00e9e : d\u2019abord une solution contenant l\u2019hyaluronidase humaine recombinante, puis, au m\u00eame site, une solution d\u2019immunoglobuline humaine normale. La posologie et la fr\u00e9quence d\u2019administration sont adapt\u00e9es au poids du patient et \u00e0 l\u2019indication, avec possibilit\u00e9 d\u2019ajustement selon la r\u00e9ponse clinique. Apr\u00e8s formation appropri\u00e9e, le patient ou son aidant peut r\u00e9aliser lui-m\u00eame les perfusions \u00e0 domicile, sous r\u00e9serve d\u2019une surveillance m\u00e9dicale. Ces \u00e9l\u00e9ments sont d\u00e9taill\u00e9s dans la notice destin\u00e9e aux patients et par les professionnels 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\/hyqvia\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>HyQvia est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte et l\u2019enfant pr\u00e9sentant des syndromes d\u2019immunod\u00e9ficience, lorsque le sang ne contient pas une quantit\u00e9 suffisante d\u2019anticorps (immunoglobulines). Il est utilis\u00e9 dans les syndromes [&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-21295","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\/21295","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=21295"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21295\/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=21295"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21295"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21295"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}