{"id":9846,"date":"2023-01-16T20:46:30","date_gmt":"2023-01-16T20:46:30","guid":{"rendered":"https:\/\/www.proveca.com\/?page_id=9846"},"modified":"2023-12-06T12:59:06","modified_gmt":"2023-12-06T12:59:06","slug":"puma","status":"publish","type":"page","link":"https:\/\/www.proveca.com\/fr\/qui-sommes-nous\/puma\/","title":{"rendered":"Autorisation de mise sur le march\u00e9 en vue d\u2019un usage p\u00e9diatrique (PUMA)"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k7qc8ed7-0a9188b28578b252ff2bbfdc1e3ce519\">\n.avia-section.av-k7qc8ed7-0a9188b28578b252ff2bbfdc1e3ce519{\nbackground-color:#ecf2f6;\nbackground-image:url(https:\/\/www.proveca.com\/wp-content\/uploads\/2020\/03\/big-leaf-4.png);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-k7qc8ed7-0a9188b28578b252ff2bbfdc1e3ce519 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='150'><div class='container av-section-cont-open' style='height:150px'><main  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9846'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k7up14rm-309c1687c14d2441696c0c2ebc6945a5\">\n.flex_column.av-k7up14rm-309c1687c14d2441696c0c2ebc6945a5{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-k7up14rm-309c1687c14d2441696c0c2ebc6945a5 av_one_full  avia-builder-el-1  avia-builder-el-no-sibling  first flex_column_div av-animated-generic left-to-right av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k7yywa5g-e753944bedc4296af72cce63d4121243\">\n#top .av-special-heading.av-k7yywa5g-e753944bedc4296af72cce63d4121243{\npadding-bottom:10px;\ncolor:#ffffff;\n}\nbody .av-special-heading.av-k7yywa5g-e753944bedc4296af72cce63d4121243 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-k7yywa5g-e753944bedc4296af72cce63d4121243 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-k7yywa5g-e753944bedc4296af72cce63d4121243 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-k7yywa5g-e753944bedc4296af72cce63d4121243 av-special-heading-h1 custom-color-heading blockquote modern-quote  avia-builder-el-2  avia-builder-el-no-sibling '><h1 class='av-special-heading-tag '  >PUMA<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='av_section_2'  class='avia-section av-ba49y2-7acfa1d8ed06a1989be0f7d47126d79f main_color avia-section-default avia-no-border-styling  avia-builder-el-3  el_after_av_section  avia-builder-el-last  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9846'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ktv9i39w-292b57410022ab7d627658789fb8edb4\">\n#top .av-special-heading.av-ktv9i39w-292b57410022ab7d627658789fb8edb4{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ktv9i39w-292b57410022ab7d627658789fb8edb4 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ktv9i39w-292b57410022ab7d627658789fb8edb4 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ktv9i39w-292b57410022ab7d627658789fb8edb4 av-special-heading-h2 blockquote modern-quote  avia-builder-el-4  el_before_av_one_full  avia-builder-el-first '><h2 class='av-special-heading-tag '  >Autorisation de mise sur le march\u00e9 en vue d\u2019un usage p\u00e9diatrique (PUMA) de la part de Proveca<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8npzze-287466476fe6e624a7b4429f6d574dbc\">\n.flex_column.av-8npzze-287466476fe6e624a7b4429f6d574dbc{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-8npzze-287466476fe6e624a7b4429f6d574dbc av_one_full  avia-builder-el-5  el_after_av_heading  el_before_av_one_full  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-k6t9u9qf-aa5942ce9e88be3b92612a6a3cbbf14c '  ><div class='avia_textblock' ><p>En juillet 2007, le r\u00e8glement p\u00e9diatrique europ\u00e9en est entr\u00e9 en vigueur pour faciliter le d\u00e9veloppement et l&rsquo;accessibilit\u00e9 de m\u00e9dicaments \u00e0 usage p\u00e9diatrique, s&rsquo;assurer que ces m\u00e9dicaments fassent l&rsquo;objet de recherches \u00e9thiques d&rsquo;une grande qualit\u00e9 et qu&rsquo;ils soient d\u00fbment autoris\u00e9s en vue d&rsquo;un usage en p\u00e9diatrie, et enfin am\u00e9liorer les informations disponibles sur l&rsquo;usage de m\u00e9dicaments au sein des diverses populations p\u00e9diatriques. Les firmes pharmaceutiques ont l\u2019obligation de d\u00e9poser un dossier d\u00e9taillant le d\u00e9veloppement p\u00e9diatrique qu\u2019elles proposent, avant toute nouvelle demande d\u2019AMM. Ce dossier doit \u00eatre accompagn\u00e9 des r\u00e9sultats des \u00e9tudes et de toutes donn\u00e9es collect\u00e9es conform\u00e9ment \u00e0 un PIP (plan d\u2019investigation p\u00e9diatrique) pr\u00e9alablement approuv\u00e9 par le Comit\u00e9 p\u00e9diatrique de l&rsquo;Agence Europ\u00e9eene des Medicaments (EMA).<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ktv9j519-6825df8c4fb108e762bff1800427e7fc\">\n#top .flex_column.av-ktv9j519-6825df8c4fb108e762bff1800427e7fc{\nmargin-top:0px;\nmargin-bottom:0px;\n}\n.responsive #top #wrap_all .flex_column.av-ktv9j519-6825df8c4fb108e762bff1800427e7fc{\nmargin-top:0px;\nmargin-bottom:0px;\n}\n<\/style>\n<div  class='flex_column av-ktv9j519-6825df8c4fb108e762bff1800427e7fc av_one_full  avia-builder-el-7  el_after_av_one_full  el_before_av_one_full  first flex_column_div  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ktv9gv05-50e2e60c07e339a26a980ad196740b11\">\n#top .av-special-heading.av-ktv9gv05-50e2e60c07e339a26a980ad196740b11{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ktv9gv05-50e2e60c07e339a26a980ad196740b11 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ktv9gv05-50e2e60c07e339a26a980ad196740b11 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ktv9gv05-50e2e60c07e339a26a980ad196740b11 av-special-heading-h3 blockquote modern-quote  avia-builder-el-8  avia-builder-el-no-sibling '><h3 class='av-special-heading-tag '  >Proveca Ltd est sp\u00e9cialis\u00e9 dans l\u2019identification, le d\u00e9veloppement et l\u2018obtention d\u2019AMM p\u00e9diatriques avec des mol\u00e9cules \u00e9prouv\u00e9es, qui ne sont plus couverte par un brevet, mais qui r\u00e9pondent \u00e0 des besoins de sant\u00e9 prioritaires chez les enfants<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div><div class='flex_column_table av-ktv9jmn3-fbb5b5a6e19c2cf021f6fefcffac4a90 sc-av_one_full av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ktv9jmn3-fbb5b5a6e19c2cf021f6fefcffac4a90\">\n#top .flex_column_table.av-equal-height-column-flextable.av-ktv9jmn3-fbb5b5a6e19c2cf021f6fefcffac4a90{\nmargin-top:0px;\nmargin-bottom:0px;\n}\n.flex_column.av-ktv9jmn3-fbb5b5a6e19c2cf021f6fefcffac4a90{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-ktv9jmn3-fbb5b5a6e19c2cf021f6fefcffac4a90 av_one_full  avia-builder-el-9  el_after_av_one_full  avia-builder-el-last  first flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-ktv9d60h-34f5154a973f1d868eea7cbf9e85f1cf '  ><div class='avia_textblock' ><p>Proveca a collabor\u00e9 avec le comit\u00e9 p\u00e9diatrique de l\u2019Agence europ\u00e9enne des m\u00e9dicaments pour obtenir, en 2016, une AMM dite PUMA pour un medicament p\u00e9diatrique.<\/p>\n<p>L&rsquo;AMM dite PUMA a \u00e9t\u00e9 introduite par le r\u00e8glement p\u00e9diatrique pour les mol\u00e9cules qui :<\/p>\n<ul>\n<li>sont d\u00e9j\u00e0 autoris\u00e9es pour les adultes ;<\/li>\n<li>ne sont plus couverts par un certificat compl\u00e9mentaire de protection (CCP) ou par un brevet qui remplit les conditions d\u2019un CCP ;<\/li>\n<li>sont d\u00e9velopp\u00e9es exclusivement pour \u00eatre utilise\u00e9s chez les enfants.<\/li>\n<\/ul>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. 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