Le 11 septembre 2026, la Commission europ\u00e9enne a retir\u00e9 l\u2019autorisation de mise sur le march\u00e9 (AMM) de Suboxone (association bupr\u00e9norphine\/naloxone) dans l\u2019Union europ\u00e9enne, \u00e0 la demande du titulaire de l\u2019AMM, la soci\u00e9t\u00e9 Indivior Europe Limited (Dublin, Irlande). L\u2019entreprise a notifi\u00e9 \u00e0 la Commission sa d\u00e9cision d\u2019arr\u00eater d\u00e9finitivement la commercialisation du produit pour des raisons commerciales.<\/p>\n
Suboxone disposait d\u2019une AMM europ\u00e9enne depuis le 26 septembre 2006 pour le traitement de substitution de la d\u00e9pendance aux opio\u00efdes, dans un cadre incluant un accompagnement m\u00e9dical, social et psychologique. Le traitement \u00e9tait destin\u00e9 aux adultes et aux adolescents de plus de 15 ans ayant accept\u00e9 une prise en charge pour addiction. L\u2019AMM, initialement valable cinq ans, avait ensuite \u00e9t\u00e9 reconduite sans limitation de dur\u00e9e \u00e0 partir de 2011. La composante naloxone du m\u00e9dicament avait pour objectif de dissuader les usages d\u00e9tourn\u00e9s par voie intraveineuse.<\/p>\n
Le retrait de l\u2019AMM intervient alors que d\u2019autres alternatives th\u00e9rapeutiques restent disponibles dans l\u2019UE, sous forme de bupr\u00e9norphine seule ou associ\u00e9e \u00e0 la naloxone, et sous diff\u00e9rentes formes pharmaceutiques. Suboxone \u00e9tait class\u00e9 dans le groupe pharmacoth\u00e9rapeutique des autres m\u00e9dicaments du syst\u00e8me nerveux (code ATC N07BC51, troubles li\u00e9s aux opio\u00efdes). Le dernier ajustement des informations relatives au produit r\u00e9sultait d\u2019une proc\u00e9dure PSUSA (PSUSA\/00002113\/2023) dat\u00e9e de juillet 2024. Le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments avait d\u00e9j\u00e0 \u00e9voqu\u00e9 ce m\u00e9dicament dans ses comptes rendus de r\u00e9union des 28\u201130 avril 2020.<\/p>\n
Les principaux acteurs mentionn\u00e9s sont la Commission europ\u00e9enne, qui a formellement proc\u00e9d\u00e9 au retrait de l\u2019AMM, Indivior Europe Limited, en tant que titulaire de l\u2019AMM et d\u00e9cisionnaire de l\u2019arr\u00eat commercial, et le CHMP, organe d\u2019\u00e9valuation scientifique. L\u2019information pr\u00e9sente un int\u00e9r\u00eat pour le suivi des politiques de prise en charge de la d\u00e9pendance aux opio\u00efdes, notamment en termes de disponibilit\u00e9 des traitements de substitution et d\u2019organisation des parcours associant soins m\u00e9dicaux, accompagnement social et soutien psychologique. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 11 septembre 2026, la Commission europ\u00e9enne a retir\u00e9 l\u2019autorisation de mise sur le march\u00e9 (AMM) de Suboxone (association bupr\u00e9norphine\/naloxone) dans l\u2019Union europ\u00e9enne, \u00e0 la demande du titulaire de l\u2019AMM, […]<\/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-18924","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\/18924","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=18924"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18924\/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=18924"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18924"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18924"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}