Le 4 mai 2026, la Commission europ\u00e9enne a retir\u00e9 l\u2019autorisation de mise sur le march\u00e9 (AMM) du m\u00e9dicament Pritor (t\u00e9lmisartan) dans l\u2019Union europ\u00e9enne. Ce retrait intervient \u00e0 la demande du titulaire de l\u2019AMM, Bayer AG, qui a notifi\u00e9 \u00e0 la Commission sa d\u00e9cision d\u2019interrompre d\u00e9finitivement la commercialisation de ce produit pour des raisons commerciales. Il n\u2019est pas indiqu\u00e9 de motif li\u00e9 \u00e0 la s\u00e9curit\u00e9 ou \u00e0 l\u2019efficacit\u00e9. Pritor \u00e9tait une sp\u00e9cialit\u00e9 \u00e0 base de t\u00e9lmisartan, appartenant au groupe pharmacoth\u00e9rapeutique des agents agissant sur le syst\u00e8me r\u00e9nine\u2011angiotensine (code ATC C09CA07), autoris\u00e9e pour le traitement de l\u2019hypertension art\u00e9rielle essentielle chez l\u2019adulte et pour la r\u00e9duction de la morbidit\u00e9 cardiovasculaire chez les patients adultes atteints d\u2019une maladie cardiovasculaire ath\u00e9rothrombotique manifeste (ant\u00e9c\u00e9dents de maladie coronarienne, d\u2019accident vasculaire c\u00e9r\u00e9bral ou de maladie art\u00e9rielle p\u00e9riph\u00e9rique) ou de diab\u00e8te de type 2 avec atteinte document\u00e9e d\u2019un organe cible.<\/p>\n
L\u2019AMM de Pritor, enregistr\u00e9e au niveau europ\u00e9en sous la r\u00e9f\u00e9rence EMEA\/H\/C\/000210, avait \u00e9t\u00e9 accord\u00e9e le 11 d\u00e9cembre 1998, apr\u00e8s une d\u00e9cision d\u2019AMM du 23 juillet 1998. Elle \u00e9tait initialement valable pour cinq ans, puis renouvel\u00e9e pour cinq ans en 2003 et enfin rendue \u00e0 dur\u00e9e illimit\u00e9e en 2008. Pritor correspondait \u00e0 une demande de duplicat du m\u00e9dicament Micardis, \u00e9galement \u00e0 base de t\u00e9lmisartan, commercialis\u00e9 dans plusieurs \u00c9tats membres de l\u2019UE. Bayer AG a indiqu\u00e9 qu\u2019elle maintenait l\u2019AMM de Micardis, de sorte que le principe actif reste disponible sur le march\u00e9 europ\u00e9en sous cette autre sp\u00e9cialit\u00e9.<\/p>\n
Plusieurs instances de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) ont pr\u00e9c\u00e9demment examin\u00e9 les m\u00e9dicaments agissant sur le syst\u00e8me r\u00e9nine\u2011angiotensine, dont le t\u00e9lmisartan. Les comit\u00e9s concern\u00e9s incluent le Comit\u00e9 d\u2019\u00e9valuation des risques en pharmacovigilance (PRAC) et le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP), qui ont, \u00e0 diff\u00e9rentes dates entre 2011 et 2013, rappel\u00e9 que le rapport b\u00e9n\u00e9fice\u2011risque des antagonistes des r\u00e9cepteurs de l\u2019angiotensine II restait favorable et ont formul\u00e9 des recommandations relatives \u00e0 leur utilisation, notamment pendant la grossesse. Une proc\u00e9dure de renvoi au titre de l\u2019article 31 sur les m\u00e9dicaments agissant sur le syst\u00e8me r\u00e9nine\u2011angiotensine est \u00e9galement mentionn\u00e9e avec une date de r\u00e9f\u00e9rence du 14 octobre 2026, sans pr\u00e9cision suppl\u00e9mentaire dans le document. Ces \u00e9l\u00e9ments confirment que la d\u00e9cision de retrait de Pritor rel\u00e8ve d\u2019un choix de l\u2019industriel et non d\u2019une r\u00e9\u00e9valuation d\u00e9favorable du rapport b\u00e9n\u00e9fice\u2011risque de la classe th\u00e9rapeutique, ce qui est un point \u00e0 prendre en compte pour le suivi de la disponibilit\u00e9 des traitements antihypertenseurs et de pr\u00e9vention cardiovasculaire au niveau europ\u00e9en. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 4 mai 2026, la Commission europ\u00e9enne a retir\u00e9 l\u2019autorisation de mise sur le march\u00e9 (AMM) du m\u00e9dicament Pritor (t\u00e9lmisartan) 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-20873","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\/20873","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=20873"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20873\/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=20873"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20873"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20873"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}