La Commission europ\u00e9enne a retir\u00e9 le 30 avril 2026 l\u2019autorisation de mise sur le march\u00e9 (AMM) du m\u00e9dicament Kinzalmono (telmisartan) dans l\u2019Union europ\u00e9enne. Ce retrait intervient \u00e0 la demande du titulaire de l\u2019AMM, la soci\u00e9t\u00e9 Bayer AG (Allemagne), 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
Kinzalmono, initialement d\u00e9nomm\u00e9 Telmisartan Boehringer Ingelheim Pharma KG, appartient au groupe pharmacoth\u00e9rapeutique des agents agissant sur le syst\u00e8me r\u00e9nine\u2011angiotensine (code ATC C09CA07). Il b\u00e9n\u00e9ficiait d\u2019une AMM europ\u00e9enne centralis\u00e9e (r\u00e9f\u00e9rence EMEA\/H\/C\/000211), accord\u00e9e le 16 d\u00e9cembre 1998 apr\u00e8s une premi\u00e8re d\u00e9cision du 23 juillet 1998. L\u2019AMM \u00e9tait valable cinq ans, renouvel\u00e9e une fois en 2003 pour cinq ans, puis transform\u00e9e en validit\u00e9 illimit\u00e9e en 2008.<\/p>\n
Le m\u00e9dicament \u00e9tait indiqu\u00e9 chez l\u2019adulte pour le traitement de l\u2019hypertension art\u00e9rielle essentielle, ainsi que pour la r\u00e9duction de la morbidit\u00e9 cardiovasculaire chez les patients pr\u00e9sentant soit une maladie cardiovasculaire ath\u00e9rothrombotique av\u00e9r\u00e9e (ant\u00e9c\u00e9dent de maladie coronarienne, d\u2019accident vasculaire c\u00e9r\u00e9bral ou de maladie art\u00e9rielle p\u00e9riph\u00e9rique), soit un diab\u00e8te de type 2 avec atteinte d\u2019organe cible document\u00e9e. Le dernier dossier de proc\u00e9dure affectant l\u2019information produit est dat\u00e9 du 3 avril 2025 (r\u00e9f\u00e9rence VR\/0000242970).<\/p>\n
Kinzalmono constituait une demande \u00ab duplicata \u00bb de Micardis, \u00e9galement \u00e0 base de telmisartan, commercialis\u00e9 dans plusieurs \u00c9tats membres de l\u2019UE. Bayer AG maintient l\u2019AMM de Micardis, ce qui signifie que le telmisartan reste disponible via ce m\u00e9dicament dans l\u2019Union. L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) et ses comit\u00e9s scientifiques sont mentionn\u00e9s dans l\u2019historique d\u2019\u00e9valuation, notamment le Comit\u00e9 pour l\u2019\u00e9valuation des risques en mati\u00e8re de pharmacovigilance (PRAC) et le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP), qui avaient d\u00e9j\u00e0 conclu que le rapport b\u00e9n\u00e9fice\u2011risque des antagonistes des r\u00e9cepteurs de l\u2019angiotensine II demeurait positif et avaient \u00e9mis des recommandations sp\u00e9cifiques pour leur utilisation pendant la grossesse. Une proc\u00e9dure de r\u00e9\u00e9valuation au titre de l\u2019article 31 concernant les agents agissant sur le syst\u00e8me r\u00e9nine\u2011angiotensine est \u00e9galement r\u00e9f\u00e9renc\u00e9e (6 octobre 2026), sans d\u00e9tail sur son contenu.<\/p>\n
Les \u00e9l\u00e9ments disponibles indiquent ainsi un retrait motiv\u00e9 par des consid\u00e9rations commerciales et non par un probl\u00e8me de s\u00e9curit\u00e9 ou d\u2019efficacit\u00e9 explicitement mentionn\u00e9, dans un contexte o\u00f9 la substance active reste accessible via un autre m\u00e9dicament (Micardis) sous AMM europ\u00e9enne. Les informations pr\u00e9sent\u00e9es peuvent int\u00e9resser le suivi des disponibilit\u00e9s th\u00e9rapeutiques et de la structuration du march\u00e9 des antihypertenseurs au niveau europ\u00e9en. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" La Commission europ\u00e9enne a retir\u00e9 le 30 avril 2026 l\u2019autorisation de mise sur le march\u00e9 (AMM) du m\u00e9dicament Kinzalmono (telmisartan) 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-20002","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\/20002","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=20002"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20002\/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=20002"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20002"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20002"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}