Le 20 octobre 2026, la Commission europ\u00e9enne a retir\u00e9 l\u2019autorisation de mise sur le march\u00e9 (AMM) du m\u00e9dicament Zinplava (bezlotoxumab) dans l\u2019Union europ\u00e9enne. Ce retrait intervient \u00e0 la demande du titulaire de l\u2019AMM, la soci\u00e9t\u00e9 Merck Sharp & Dohme B.V. (Pays-Bas), qui a inform\u00e9 la Commission de sa d\u00e9cision d\u2019arr\u00eater d\u00e9finitivement la commercialisation du produit pour des raisons commerciales. Aucune autre motivation n\u2019est mentionn\u00e9e.<\/p>\n
Zinplava avait obtenu une AMM europ\u00e9enne le 18 janvier 2017, apr\u00e8s une d\u00e9cision d\u2019autorisation en date du 10 novembre 2016. Le m\u00e9dicament \u00e9tait indiqu\u00e9 pour la pr\u00e9vention des r\u00e9cidives d\u2019infection \u00e0 Clostridium difficile (ICD) chez les adultes \u00e0 haut risque de r\u00e9cidive. Class\u00e9 dans le groupe pharmacoth\u00e9rapeutique des s\u00e9rums immunitaires et immunoglobulines (code J06BB21), il s\u2019agissait d\u2019un anticorps monoclonal (bezlotoxumab) utilis\u00e9 en compl\u00e9ment du traitement standard de l\u2019ICD. L\u2019AMM \u00e9tait initialement valable pour cinq ans, puis a \u00e9t\u00e9 convertie en dur\u00e9e illimit\u00e9e en 2021. Une extension d\u2019indication aux enfants \u00e0 partir de 1 an a \u00e9t\u00e9 accord\u00e9e en d\u00e9cembre 2023, \u00e0 la suite d\u2019une proc\u00e9dure \u00e9valu\u00e9e par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), comme en t\u00e9moignent les comptes rendus de r\u00e9unions de d\u00e9cembre 2016 et d\u00e9cembre 2023.<\/p>\n
Le retrait de l\u2019AMM met fin \u00e0 la disponibilit\u00e9 r\u00e9glementaire de Zinplava dans l\u2019ensemble de l\u2019UE, y compris en France, pour la pr\u00e9vention des r\u00e9cidives d\u2019ICD chez les populations \u00e0 haut risque. Il r\u00e9sulte d\u2019un choix industriel et non d\u2019une d\u00e9cision de s\u00e9curit\u00e9 ou d\u2019efficacit\u00e9 mentionn\u00e9e par les autorit\u00e9s. Aucun \u00e9l\u00e9ment n\u2019est fourni sur l\u2019existence d\u2019alternatives th\u00e9rapeutiques sp\u00e9cifiques ou sur des mesures d\u2019accompagnement. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 20 octobre 2026, la Commission europ\u00e9enne a retir\u00e9 l\u2019autorisation de mise sur le march\u00e9 (AMM) du m\u00e9dicament Zinplava (bezlotoxumab) dans l\u2019Union europ\u00e9enne. Ce retrait intervient \u00e0 la demande du […]<\/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-21535","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\/21535","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=21535"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21535\/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=21535"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21535"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21535"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}