L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a publi\u00e9 une information de s\u00e9curit\u00e9 concernant les sp\u00e9cialit\u00e9s ntir\u00e9trovirales\u00a0Efavirenz 600 mg \/ Emtricitabine 200 mg \/ T\u00e9nofovir disoproxil 245 mg\u00a0des laboratoires Biogaran et EG Labo. L\u2019autorisation de mise sur le march\u00e9 (AMM) de ces m\u00e9dicaments a \u00e9t\u00e9\u00a0suspendue\u00a0suite \u00e0 une d\u00e9cision de la\u00a0Commission europ\u00e9enne, cons\u00e9cutivement \u00e0 une\u00a0r\u00e9\u00e9valuation europ\u00e9enne\u00a0du dossier d\u2019AMM.<\/p>\n
Pourquoi cette suspension\u202f?<\/p>\n
La Commission europ\u00e9enne a conclu \u00e0 l\u2019absence de d\u00e9monstration de la bio\u00e9quivalence<\/a>\u00a0entre ces sp\u00e9cialit\u00e9s g\u00e9n\u00e9riques et la sp\u00e9cialit\u00e9\u00a0de r\u00e9f\u00e9rence (Atripla<\/a>, en arr\u00eat de commercialisation depuis 2021).\u00a0<\/p>\n \u00c0 ce jour, l\u2019ANSM pr\u00e9cise qu\u2019aucune r\u00e9clamation qualit\u00e9\u00a0ni\u00a0aucun cas de pharmacovigilance\u00a0n\u2019a \u00e9t\u00e9 signal\u00e9 en lien avec ces lots.\u00a0D\u2019autres sp\u00e9cialit\u00e9s sont d\u00e9j\u00e0 disponibles pour assurer la continuit\u00e9 de la prise en charge<\/a> des patients.<\/p>\n Les lots rappel\u00e9s\u00a0Efavirenz\/Emtricitabine\/T\u00e9nofovir Disoproxil Biogaran 600 mg\/200 mg\/245 mg, comprim\u00e9 pellicul\u00e9 bo\u00eete de 30 (CIP : 34009 301 175 1 4) :\u00a0Lot 118561 (p\u00e9remption 06\/2028)Efavirenz\/Emtricitabine\/T\u00e9nofovir Disoproxil EG 600 mg\/200 mg\/245 mg, comprim\u00e9 pellicul\u00e9 bo\u00eete de 30 (CIP : 3400930117583) : Lot 107938 (p\u00e9remption 10\/2026) et Lot 112858 (p\u00e9remption 09\/2027)Information m\u00e9dicale\u00a0<\/p>\n Pour toute question, il est possible de contacter les laboratoires via les num\u00e9ros ci-dessous :\u00a0<\/p>\n Biogaran :\u00a00811 907 917Laboratoires EG Labo : 01 46 94 86 86<\/p>\n","protected":false},"excerpt":{"rendered":"L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a publi\u00e9 une information de s\u00e9curit\u00e9…\n","protected":false},"author":2,"featured_media":149335,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[9],"tags":[83,6661,31278,84,23,4359],"class_list":["post-149334","post","type-post","status-publish","format-standard","has-post-thumbnail","category-sante","tag-health","tag-qualite","tag-rappel-produits","tag-sante","tag-suisse","tag-vih"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch_fr\/116647066605947359","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/posts\/149334","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/comments?post=149334"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/posts\/149334\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/media\/149335"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/media?parent=149334"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/categories?post=149334"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/tags?post=149334"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}