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Glossaire ANSM | A

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href="/glossaire/C" class="letter ">C</a> <a href="/glossaire/D" class="letter ">D</a> <a href="/glossaire/E" class="letter ">E</a> <a href="/glossaire/F" class="letter ">F</a> <a href="/glossaire/G" class="letter ">G</a> <a href="/glossaire/H" class="letter ">H</a> <a href="/glossaire/I" class="letter ">I</a> <a href="/glossaire/J" class="letter ">J</a> <a href="/glossaire/K" class="letter ">K</a> <a href="/glossaire/L" class="letter ">L</a> <a href="/glossaire/M" class="letter ">M</a> <a href="/glossaire/N" class="letter ">N</a> <a href="/glossaire/O" class="letter ">O</a> <a href="/glossaire/P" class="letter ">P</a> <a href="/glossaire/Q" class="letter ">Q</a> <a href="/glossaire/R" class="letter ">R</a> <a href="/glossaire/S" class="letter ">S</a> <a href="/glossaire/T" class="letter ">T</a> <a href="/glossaire/U" class="letter ">U</a> <a href="/glossaire/V" class="letter ">V</a> <a href="/glossaire/W" class="letter ">W</a> <a href="/glossaire/X" class="letter ">X</a> <a href="/glossaire/Y" class="letter ">Y</a> <a href="/glossaire/Z" class="letter ">Z</a> </div> </div> <div class="white-bg"> <div class="ml-container container"> <div id="pt-filters" class="pt-filter-row pt-filter-row-cyan ckbox-cyan collapse"> <div class="filters-row"> <div class="row"> <div class="col-md-4"> <div class="form-group ptf-item"> <div class="ckbox"> <label> <input type="checkbox" name="d"> <span>Vie de l'agence</span> </label> <a class="ptfi-toggle" href="#"><!----></a> </div> <div class="ptfi-collapse collapse"> <div class="ptfi-collapse-sub"> <div class="ckbox"> <label> <input type="checkbox" name="s"> <span>AMM</span> </label> </div> </div> </div> </div> </div> <div class="col-md-4"> <div class="form-group ptf-item"> <div class="ckbox"> <label> <input type="checkbox" name="d"> <span>D茅cisions</span> </label> <a class="ptfi-toggle" href="#"><!----></a> </div> </div> </div> <div class="col-md-4"> <div class="form-group ptf-item"> <div class="ckbox"> <label> <input type="checkbox" name="d"> <span>R茅f茅rentiels</span> </label> <a class="ptfi-toggle" href="#"><!----></a> </div> </div> </div> </div> <div class="row"> <div class="col-md-4"> <div class="form-group ptf-item"> <div class="ckbox"> <label> <input type="checkbox" name="d"> <span>Innovation</span> </label> <a class="ptfi-toggle" href="#"><!----></a> </div> <div class="ptfi-collapse collapse"> <div class="ptfi-collapse-sub"> <div class="ckbox"> <label> <input type="checkbox" name="s"> <span>AMM</span> </label> </div> <div class="ckbox"> <label> <input type="checkbox" name="s"> <span>ATU</span> </label> </div> <div class="ckbox"> <label> <input type="checkbox" name="s"> <span>RTU</span> </label> </div> <div class="ckbox"> <label> <input type="checkbox" name="s"> <span>Essais cliniques</span> </label> </div> </div> </div> </div> </div> <div class="col-md-4"> <div class="form-group ptf-item"> <div class="ckbox"> <label> <input type="checkbox" name="d"> <span>Surveillance</span> </label> <a class="ptfi-toggle" href="#"><!----></a> </div> </div> </div> <div class="col-md-4"> <div class="form-group ptf-item"> <div class="ckbox"> <label> <input type="checkbox" name="d"> <span>Pr茅vention</span> </label> <a class="ptfi-toggle" href="#"><!----></a> </div> </div> </div> </div> </div> </div> </div> </div> <div class="main-container container"> <div class="glossary"> <dl class="terms-list"> <div class="item" id="absorption"> <dt>Absorption</dt> <dd> <p>Processus par lequel une substance p茅n猫tre dans le sang et /ou dans le syst猫me lymphatique (ISO10993-16).</p> </dd> </div> <div class="item" id="abus"> <dt>Abus</dt> <dd> <p>L' abus est l'utilisation excessive et volontaire, permanente ou intermittente, d'une ou plusieurs substances psychoactives, ayant des cons茅quences pr茅judiciables 脿 la sant茅 physique ou psychique (article R.5219-1). </p> </dd> </div> <div class="item" id="acide-hyaluronique"> <dt>Acide hyaluronique</dt> <dd><p>Aussi appel&eacute; hyaluronate de sodium est un composant des tissus humains. Il est principalement situ&eacute; dans la peau. Dans l&rsquo;industrie il peut &ecirc;tre fabriqu&eacute; &agrave; partir de culture cellulaire ou extrait de la cr&ecirc;te de coq.</p></dd> </div> <div class="item" id="addictovigilance"> <dt>Addictovigilance</dt> <dd>Surveillance, &eacute;valuation, pr&eacute;vention et gestion du risque des cas d'abus, d'usage d&eacute;tourn&eacute; et de d&eacute;pendance li&eacute;s &agrave; la consommation qu&rsquo;elle soit m&eacute;dicamenteuse ou non, de tout produit, substance ou plante ayant un effet psychoactif (&agrave; l&rsquo;exclusion de l&rsquo;alcool &eacute;thylique et du tabac) (<a href="https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000033897144/" target="_blank" rel="noopener">Art. L.5133-1 du Code de la sant&eacute; publique</a>)</dd> </div> <div class="item" id="adlf"> <dt>ADLF</dt> <dd>Association des lactariums de France</dd> </div> <div class="item" id="afm"> <dt>AFM</dt> <dd>Association fran&ccedil;aise contre les myopathies</dd> </div> <div class="item" id="afnp"> <dt>AFNP</dt> <dd>Association fran&ccedil;aise contre les neuropathies p&eacute;riph&eacute;riques</dd> </div> <div class="item" id="afpa"> <dt>AFPA</dt> <dd>Association fran&ccedil;aise de p&eacute;diatrie ambulatoire</dd> <a target="_blank" href="https://afpa.org/" class="more-title mt-cyan"> <span>AFPA</span> </a> </div> <div class="item" id="afpral"> <dt>AFPRAL</dt> <dd>Association Fran&ccedil;aise pour la Pr&eacute;vention des Allergies</dd> <a target="_blank" href="https://allergies.afpral.fr/" class="more-title mt-cyan"> <span>site de l&#039;AFPRAL</span> </a> </div> <div class="item" id="agents-biologiques"> <dt>Agents biologiques</dt> <dd> <p>Micro-organismes, y compris les micro-organismes obtenus par ing茅nierie g茅n茅tique, culture de cellules et endoparasites, pathog猫nes ou non. </p> </dd> </div> <div class="item" id="agents-biologiques-pathogenes"> <dt>Agents biologiques pathog猫nes</dt> <dd> <p>Agents biologiques susceptibles de provoquer une infection, une allergie ou une toxicit茅 ou de constituer de toute autre fa莽on un risque pour la sant茅 humaine </p> </dd> </div> <div class="item" id="alerte"> <dt>Alerte</dt> <dd> <p>Information re莽ue ou 茅mise dont le contenu pr茅sente un caract猫re de gravit茅 potentiel ou av茅r茅 tel qu鈥檌l n茅cessite la mise en oeuvre, en urgence, d鈥檃ctions correctives ou pr茅ventives.</p> </dd> </div> <div class="item" id="allergene-sensibilisant"> <dt>Allerg猫ne/sensibilisant</dt> <dd> <p>Substance/mat茅riau capable d鈥檌nduire des effets allergiques.</p> </dd> </div> <div class="item" id="allergie-peau"> <dt>Allergie (peau)</dt> <dd> <p>R茅action anormale pathologique et sp茅cifique de l'organisme au contact avec une substance 茅trang猫re (allerg猫ne) pouvant provoquer un prurit (d茅mangeaison) et la formation d'un 茅ryth猫me.</p> </dd> </div> <div class="item" id="allo-immunisation-isolee"> <dt>Allo-immunisation isol茅e</dt> <dd>L&rsquo;allo-immunisation isol&eacute;e est une r&eacute;ponse immunitaire habituelle lorsqu&rsquo;on est expos&eacute; &agrave; un antig&egrave;ne que l&rsquo;on ne poss&egrave;de pas. Cette r&eacute;ponse ne provoque pas de sympt&ocirc;me chez le patient. Elle sera d&eacute;tect&eacute;e gr&acirc;ce &agrave; la r&eacute;alisation d&rsquo;une &laquo;&nbsp;recherche d&rsquo;anticorps sp&eacute;cialis&eacute; (RAI)&nbsp;&raquo;, un examen au cours duquel on recherche chez le patient des anticorps qui n&rsquo;&eacute;taient pas pr&eacute;sents avant la transfusion et qui ont &eacute;t&eacute; produit par le patient en r&eacute;action &agrave; l&rsquo;antig&egrave;ne pr&eacute;sent dans le PSL transfus&eacute;.<br /><br />La pr&eacute;sence de ces nouveaux anticorps chez le patient sera prise en compte lors d&rsquo;une nouvelle transfusion et du choix des produits sanguins (PSL) qui seront transfus&eacute;s. L&rsquo;objectif est d&rsquo;&eacute;viter de transfuser au patient des PSL portant cet antig&egrave;ne et qui provoqueraient chez le patient une r&eacute;action immunitaire pouvant &ecirc;tre &agrave; l&rsquo;origine de la destruction des globules rouges apport&eacute;s par la transfusion.</dd> </div> <div class="item" id="analgesie-multimodale"> <dt>Analg茅sie multimodale</dt> <dd>Prise en charge de la douleur par l&rsquo;administration de plusieurs m&eacute;dicaments</dd> </div> <div class="item" id="anemie-foetale"> <dt>An茅mie f艙tale</dt> <dd>Destruction des globules rouges du f&oelig;tus</dd> </div> <div class="item" id="anses"> <dt>ANSES</dt> <dd> <p>聽Agence nationale de s茅curit茅 sanitaire de l鈥檃limentation, de l鈥檈nvironnement et du travail</p> </dd> </div> <div class="item" id="anti-inflammatoires-non-steroidiens-ains"> <dt>Anti-inflammatoires non st茅ro茂diens (AINS)</dt> <dd>Les anti-inflammatoires non st&eacute;ro&iuml;diens (AINS) sont une classe de m&eacute;dicaments &eacute;tendue, comprenant de nombreuses mol&eacute;cules telles que l'ibuprof&egrave;ne. Ils agissent en bloquant la formation des prostaglandines, les substances responsables de l'inflammation.</dd> </div> <div class="item" id="asos"> <dt>ASOS</dt> <dd>Antalgiques Stup&eacute;fiants et Ordonnances S&eacute;curis&eacute;es. Enqu&ecirc;te transversale r&eacute;alis&eacute;e tous les ans pendant une semaine aupr&egrave;s d'un &eacute;chantillon national tir&eacute; au sort de 1500 pharmacies d'officine sur la prescription d'antalgiques stup&eacute;fiants.</dd> </div> <div class="item" id="atu"> <dt>ATU</dt> <dd>Autorisation Temporaire d&rsquo;Utilisation.</dd> </div> <div class="item" id="autorisation-de-mise-sur-le-marche-amm"> <dt>Autorisation de mise sur le march茅 (AMM)</dt> <dd> <p> L鈥橝utorisation de mise sur le march茅 (AMM) constitue un pr茅alable obligatoire 脿 toute possibilit茅 de commercialisation d鈥檜ne sp茅cialit茅 pharmaceutique. Elle est 茅galement indispensable avant la demande d鈥檌nscription au remboursement par l鈥橝ssurance Maladie.<br> 聽En France, l'AMM est d茅livr茅e par l鈥橝gence fran莽aise de s茅curit茅 du m茅dicament et des produits de sant茅 (ANSM).</p> </dd> </div> <div class="item" id="autorisation-temporaire-dutilisation-de-cohorte-atuc"> <dt>Autorisation temporaire d&#039;utilisation de cohorte (ATUc)</dt> <dd><p>L'ATU dite de cohorte :<br />Concerne un groupe ou sous-groupe de patients, trait&eacute;s et surveill&eacute;s suivant des crit&egrave;res parfaitement d&eacute;finis dans un protocole d'utilisation th&eacute;rapeutique et de recueil d'informations. <br />L'ATU de cohorte est d&eacute;livr&eacute;e &agrave; la demande du titulaire des droits d'exploitation, qui s'engage &agrave; d&eacute;poser une demande d'AMM dans un d&eacute;lai fix&eacute;.</p></dd> <a target="_self" href="https://ansm.sante.fr/glossaire/P#protocole-dutilisation-therapeutique-put" class="more-title mt-cyan"> <span>Protocole d&#039;utilisation temporaire (PUT)</span> </a> </div> <div class="item" id="autorisation-temporaire-dutilisation-nominative-atun"> <dt>Autorisation temporaire d&#039;utilisation nominative (ATUn)</dt> <dd><p>L'ATU nominative est d&eacute;livr&eacute;e pour un seul malade nomm&eacute;ment d&eacute;sign&eacute;, &agrave; la demande et sous la responsabilit&eacute; du m&eacute;decin prescripteur.<br />L&rsquo;ATU est une proc&eacute;dure exceptionnelle, d&eacute;rogatoire, qui permet l&rsquo;acc&egrave;s &agrave; des m&eacute;dicaments n&rsquo;ayant pas d&rsquo;AMM en France et pour lesquels aucune alternative th&eacute;rapeutique n&rsquo;est disponible. <br />Les m&eacute;dicaments mis &agrave; disposition dans le cadre d&rsquo;ATU nominatives (pour des patients nomm&eacute;ment d&eacute;sign&eacute;s) ne peuvent &ecirc;tre d&eacute;livr&eacute;s que dans des pharmacies hospitali&egrave;res.</p></dd> </div> </dl> </div> <footer id="footer" class=" no-border-top"> <div class="row" role="navigation"> <div class="ft-col col-md-2"> <a class="ft-title" role="link" href="https://ansm.sante.fr/qui-sommes-nous/" target="_self" title="Qui sommes-nous ?">Qui sommes-nous ?</a> <div class="ft-content"> <p><span style="color: #5e2a7e;"><strong><a style="color: #5e2a7e;" href="https://ansm.sante.fr/actualites/a-la-une">Actualit&eacute;s</a></strong></span><br /><span style="color: #5e2a7e;"><a style="color: #5e2a7e;" href="https://ansm.sante.fr/disponibilites-des-produits-de-sante/medicaments"><strong>Disponibilit&eacute;s des produits de sant&eacute;</strong></a></span></p> </div> <a class="ft-title" role="link" href="https://ansm.sante.fr/documents/reference/" target="_self" title="Documents de r茅f茅rence">Documents de r茅f茅rence</a> <div class="ft-content"> <span style="color: #5e2a7e;"><strong><a style="color: #5e2a7e;" href="https://ansm.sante.fr/informations-de-securite/">Informations de s&eacute;curit&eacute;</a></strong></span><br /><span style="color: #5e2a7e;"><strong><a style="color: #5e2a7e;" href="https://ansm.sante.fr/dossiers-thematiques/a-la-une">Dossiers th&eacute;matiques</a></strong></span> </div> </div> <div class="ft-col col-md-2"> <a class="ft-title" role="link" href="https://ansm.sante.fr/vos-demarches/professionel-de-sante/lancer-une-alerte-de-securite-sanitaire" target="_self" title="Lancer une alerte">Lancer une alerte</a> <div class="ft-content"> <p><span style="color: #5e2a7e;"><a style="color: #5e2a7e;" href="https://ansm.sante.fr/documents/reference/declarer-un-effet-indesirable"><strong>D&eacute;clarer un effet ind&eacute;sirable</strong></a></span></p> </div> <span class="ft-title" role="link" title="Vos d茅marches">Vos d茅marches</span> <div class="ft-content"> <span style="color: #5e2a7e;"><a style="color: #5e2a7e;" href="https://ansm.sante.fr/vos-demarches/industriel">- Industriel</a></span><br /><span style="color: #5e2a7e;"><a style="color: #5e2a7e;" href="https://ansm.sante.fr/vos-demarches/organismes-notifies">- Organisme notifi&eacute;</a></span><br /><span style="color: #5e2a7e;"><a style="color: #5e2a7e;" href="https://ansm.sante.fr/vos-demarches/professionel-de-sante">- Professionnel de sant&eacute;</a></span><br /><span style="color: #5e2a7e;"><a style="color: #5e2a7e;" href="https://ansm.sante.fr/vos-demarches/patient">- Patient</a></span><br /><span style="color: #5e2a7e;"><a style="color: #5e2a7e;" href="https://ansm.sante.fr/vos-demarches/chercheur">- Chercheur</a></span> </div> </div> <div class="ft-col col-md-2"> <a class="ft-title" role="link" href="https://data.ansm.sante.fr/" target="_blank" title="Data ANSM">Data ANSM</a> <div class="ft-content"> <span style="color: #5e2a7e;"><strong><a style="color: #5e2a7e;" href="https://ansm.sante.fr/documents/reference/repertoires-des-essais-cliniques-de-medicaments">R&eacute;pertoire des essais cliniques de m&eacute;dicaments</a></strong><strong><br /><a style="color: #5e2a7e;" href="https://ansm.sante.fr/documents/reference/repertoire-des-medicaments" target="_blank" rel="noopener">R&eacute;pertoire des m&eacute;dicaments</a></strong><strong><br /><a style="color: #5e2a7e;" href="http://base-donnees-publique.medicaments.gouv.fr/" target="_blank" rel="noopener">Base de donn&eacute;es publique des m&eacute;dicaments</a></strong></span> </div> <a class="ft-title" role="link" href="https://archive.ansm.sante.fr/" target="_self" title="Archives ANSM">Archives ANSM</a> <div class="ft-content"> <span style="color: #5e2a7e;"><strong><a style="color: #5e2a7e;" href="https://ansm.sante.fr/glossaire">Glossaire</a></strong></span> </div> </div> <div class="ft-col col-md-2"> <span class="ft-title" role="link" title="Restez inform茅s">Restez inform茅s</span> <div class="ft-content"> <span style="color: #5e2a7e;"><a style="color: #5e2a7e;" href="https://ansm.sante.fr/newsletter/login">- S'inscrire &agrave; 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