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+ <div class="sub_section ">
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+ <div class="left_column_link"><a href="/Activites/Autorisations-de-mise-sur-le-marche" >
+ Autorisations de mise sur le marché
+ </a></div>
+ </div>
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+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Liberation-de-lots-et-de-vaccins" >
+ Libération de lots et de vaccins
+ </a></div>
+ </div>
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+ </div>
+ <div class="sub_section ">
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+ Mise sur le marché des dispositifs médicaux et dispositifs médicaux de diagnostic in vitro (DM/DMIA/DMDIV)
+ </a></div>
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+ </div>
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+ <div class="left_column_link"><a href="/Activites/Medicaments-en-pediatrie" >
+ Médicaments en pédiatrie
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+ </div><br/>
+ <div class="sous_titre_menu"><a href="javascript:montrerCacher('sub9')"><img id="isub9" src="/design/afssaps/images/fleche_menu.gif" alt="" /> Surveiller les produits de santé et les analyses de biologie médicale
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+ Biocides - Appareils de désinfection par voie aérienne
+ </a></div>
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+ <div class="left_column_link"><a href="/Activites/Controle-national-de-qualite-des-analyses-de-biologie-medicale-CNQ" >
+ Contrôle national de qualité des analyses de biologie médicale (CNQ)
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
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+ Contrôle en laboratoire
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+ Falsifications de produits de santé
+ </a></div>
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+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Maintenance-et-controle-qualite-des-DM" >
+ Maintenance et contrôle qualité des DM
+ </a></div>
+ </div>
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+ </div>
+ <div class="sub_section ">
+ <div class="links">
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+ Préparations hospitalières
+ </a></div>
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+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Surveillance-des-dispositifs-medicaux-implantables" >
+ Surveillance des dispositifs médicaux implantables
+ </a></div>
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+ Surveillance des médicaments
+ </a></div>
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+ </div>
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+ Surveillance des stupéfiants et des psychotropes
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+ <div class="left_column_link"><a href="/Activites/Surveillance-des-vaccins" >
+ Surveillance des vaccins
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+ </div>
+ <div class="sub_section ">
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+ <div class="left_column_link"><a href="/Activites/Surveillance-du-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMDIV" >
+ Surveillance du marché des dispositifs médicaux et dispositifs médicaux de diagnostic in vitro (DM/DMDIV)
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
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+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Surveillance-du-marche-des-produits-cosmetiques" >
+ Surveillance du marché des produits cosmétiques
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Surveillance-du-marche-des-produits-de-tatouage" >
+ Surveillance du marché des produits de tatouage
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ </div><br/>
+ <div class="sous_titre_menu"><a href="javascript:montrerCacher('sub10')"><img id="isub10" src="/design/afssaps/images/fleche_menu.gif" alt="" /> Contrôler la publicité
+</a></div>
+ <div id="sub10" style="display:none">
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Publicite-pour-les-medicaments" >
+ Publicité pour les médicaments
+ </a></div>
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+ <div class="sub_section ">
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+ <div class="left_column_link"><a href="/Activites/Publicite-pour-les-dispositifs-medicaux-et-autres-produits-de-sante" >
+ Publicité pour les dispositifs médicaux et autres produits de santé
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Publicite-pour-les-objets-appareils-et-methodes" >
+ Publicité pour les objets appareils et méthodes
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Programmes-d-apprentissage" >
+ Programmes d'apprentissage
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ </div><br/>
+ <div class="sous_titre_menu"><a href="javascript:montrerCacher('sub11')"><img id="isub11" src="/design/afssaps/images/fleche_menu.gif" alt="" /> Assurer les vigilances
+</a></div>
+ <div id="sub11" style="display:none">
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Comment-signaler-ou-declarer" >
+ Comment signaler ou déclarer
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Systemes-de-vigilances-de-l-Agence" >
+ Systèmes de vigilances de l'Agence
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Biovigilance" >
+ Biovigilance
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Cosmetovigilance" >
+ Cosmétovigilance
+ </a></div>
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+ </div>
+ <div class="sub_section ">
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+ <div class="left_column_link"><a href="/Activites/Hemovigilance" >
+ Hémovigilance
+ </a></div>
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+ </div>
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Materiovigilance" >
+ Matériovigilance
+ </a></div>
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+ </div>
+ <div class="sub_section ">
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+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Pharmacovigilance" >
+ Pharmacovigilance
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Pharmacodependance-Addictovigilance" >
+ Pharmacodépendance (Addictovigilance)
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ <div class="sub_section ">
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+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Reactovigilance" >
+ Réactovigilance
+ </a></div>
+ </div>
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+ </div>
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Vigilance-des-produits-de-tatouage" >
+ Vigilance des produits de tatouage
+ </a></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ </div><br/>
+ <div class="sous_titre_menu"><a href="javascript:montrerCacher('sub12')"><img id="isub12" src="/design/afssaps/images/fleche_menu.gif" alt="" /> Taxes
+</a></div>
+ <div id="sub12" style="display:none">
+ <div class="sub_section ">
+ <div class="links">
+ <div class="links_bullet" >></div>
+ <div class="left_column_link"><a href="/Activites/Taxes" >
+ Taxes
+ </a></div>
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+ <div class="box_content">
+
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Repertoire-des-medicaments">Répertoire des médicaments</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Base-de-donnees-des-etablissements-pharmaceutiques">Base de données des établissements pharmaceutiques</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Declaration-des-codes-LPP">Déclaration des codes LPP</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Declaration-des-etablissements-de-fabrication-distribution-et-importation-de-matieres-premieres">Déclaration des établissements de fabrication, distribution et importation de matières premières</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Fidnet-consultation-en-ligne-des-declarations-d-interets">Fidnet - consultation en ligne des déclarations d'intérêts</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/E-Fides-teledeclaration-des-interets">E-Fides télédéclaration des intérêts</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/E-FIT">E-FIT</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Obtention-du-numero-d-enregistrement-pour-les-essais-cliniques">Obtention du numéro d'enregistrement pour les essais cliniques</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Offres-d-emploi">Offres d’emploi</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Prise-en-charge-des-deplacements">Prise en charge des déplacements</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Repertoire-public-des-essais-cliniques-de-medicaments">Répertoire public des essais cliniques de médicaments</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Suivi-des-signalements-de-materiovigilance">Suivi des signalements de matériovigilance</a></div></div>
+
+ <div class="sub_section"><div class="links_bullet">></div><div class="left_column_link"><a href="/Services/Teledeclaration-des-preparations-hospitalieres">Télédéclaration des préparations hospitalières</a></div></div>
+ </div>
+ <div class="breaker"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ <div class="box_bottom"><img src="/design/afssaps/images/blank.gif" alt="" /></div>
+ </div>
+ </div>
+ </div>
+ </div>
+ <div id="column_content" class="column_content column_reduce">
+
+
+
+<div class="minimum_top_bloc" id="top_chapter">
+<div class="content_header">
+ <div class="plain_box_top_corner_left">
+ <div class="plain_box_top_corner_right">
+ <div class="plain_box_top_border"></div>
+ </div>
+ </div>
+ <div class="block_body">
+ <h3>Surveillance des médicaments</h3>
+ <div class=text>
+ <form action="/redirectextension/redirect" id="change_paragraph" name="change_paragraph" method="get">
+<ul>
+ <li><a href="Activites/Surveillance-des-medicaments/Surveillance-des-medicaments/(offset)/0">Surveillance des médicaments</a></li>
+ <li><a href="Activites/Surveillance-des-medicaments/Medicaments-retires-du-marche/(offset)/1">Médicaments retirés du marché</a></li>
+ <li><a href="Activites/Surveillance-des-medicaments/Medicaments-sous-surveillance-renforcee2/(offset)/2">Médicaments sous surveillance renforcée</a></li>
+ <li><a href="Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques/(offset)/3"><b>Médicaments faisant l'objet d'un plan de gestion des risques</b></a></li>
+ </ul>
+ <input type="hidden" name="url" value="Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques" />
+ <input type="hidden" name="offset" id="selected_chapter" />
+ </form>
+ </div></div>
+ <div class="plain_box_bottom_corner_left">
+ <div class="plain_box_bottom_corner_right">
+ <div class="plain_box_bottom_border"></div>
+ </div>
+ </div>
+</div>
+</div>
+<div id="project_chapter" class="column_content">
+
+
+<div class="page_numbering">
+
+
+
+ <span class="page_button_middle" ><a href="/Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques/(offset)/2" ><img src="/design/afssaps/images/arrow_purple_left.gif" alt="" /></a></span>
+
+
+
+
+ <span class="other"><a href="/Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques/(offset)/0">1</a></span>
+ <span class="other"><a href="/Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques/(offset)/1">2</a></span>
+ <span class="other"><a href="/Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques/(offset)/2">3</a></span>
+
+ <span><a href="#" class="page_current">4</a></span>
+
+
+
+
+
+
+
+ <span class="page_button_middle" ><a href="#" ><img src="/design/afssaps/images/arrow_purple_right.gif" alt="" /></a></span>
+
+
+ <div class="break"></div>
+
+</div>
+
+
+
+ <div class="list">
+
+
+<div class="paragraph " >
+ <a name="paragraph_37512"></a><h3 class="title">Médicaments faisant l’objet d’un Plan de Gestion des Risques (PGR)</h3>
+ <div class="separator"><img src="/design/afssaps/images/blank.gif" alt="" width="1" height="0" /></div>
+ <div class="text" ><div class="online_editor">
+<p>Un plan de gestion des risques (PGR) est requis tous les médicaments contenant une nouvelle substance active.</p>
+<p>Il peut aussi être mis en place après la commercialisation du produit si des changements significatifs interviennent (nouvelle indication, nouveau dosage, nouvelle voie d’administration, nouveau procédé de fabrication) ou si un risque important a été identifié après la mise sur le marché.</p>
+<p>Il permet :</p>
+
+<ul>
+
+<li>de mieux caractériser ou prévenir les risques associés à un médicament,</li>
+
+<li>de compléter les données disponibles au moment de la mise sur le marché,</li>
+
+<li>de surveiller les conditions réelles d'utilisation.</li>
+
+</ul>
+<p>Il implique, lorsque nécessaire, des mesures complémentaires aux activités de routine, comme :</p>
+
+<ul>
+
+<li>une pharmacovigilance renforcée sur certains des risques mis en évidence dans le PGR,</li>
+
+<li>des études de sécurité d’emploi post-AMM et/ou des études d’utilisation,</li>
+
+<li>des mesures de minimisation du risque (documents d’information pour les professionnels de santé ou les patients).</li>
+
+</ul>
+<p>Le PGR a été mis en place en 2005 dans le cadre d’une réglementation européenne et fait partie du dossier d’Autorisation de Mise sur le Marché (AMM).</p>
+<p>Les médicaments listés ci-dessous font l’objet d’un PGR pour lequel au moins une mesure a été validée ou mise en place par l’ANSM, c’est à dire :</p>
+
+<ul>
+
+<li>des médicaments dont l’AMM nationale inclut un PGR (classés PGR National)</li>
+
+<li>des médicaments dont l’AMM européenne inclut un PGR dont certaines mesures (documents de minimisation ou protocoles d’études conduites en France) ont été validées par l’ANSM (classés PGR Européen). </li>
+
+<li>des médicaments dont l’AMM européenne inclut un PGR complété par des mesures additionnelles au niveau national (classés PGR Européen et National). </li>
+
+</ul>
+<p>Les PGR européens ne comprenant pas de mesures impactant la mise à disposition du produit au niveau national ne sont pas listés.</p>
+<p>Les informations sur les médicaments enregistrés au niveau de l’Agence Européenne (EMA) sont accessibles sur le site <a href="http://www.ema.europa.eu" target="_blank">www.ema.europa.eu</a>
+</p>
+
+<div class="">
+
+<div class="publication">
+<ul>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/6d6dccc3b2de33b8685b93dd5375a497.pdf" target="_blank"> ABSTRAL (21/09/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (59 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/dc21b76c363f06b65935c095a3dfb87c.pdf" target="_blank"> ACLASTA (30/05/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (35 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/bd217cc6e3901ae761b47dfad5030e9a.pdf" target="_blank"> ALLI (17/12/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (110 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/d9191067018a315a919928fa5c488e91.pdf" target="_blank"> ARAVA (01/06/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (31 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/381c5797118cc60c9c32b0a5036ae709.pdf" target="_blank"> ARCOXIA (12/03/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (118 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/d56c3546492a27350b51b5f2fb0ea189.pdf" target="_blank"> BYETTA (03/04/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (69 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/b7e416cddba9728ca548e9d4fd9db534.pdf" target="_blank"> CELSENTRI (21/09/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (32 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/fdb07e16d1a207fe353dfbe629d933e3.pdf" target="_blank"> CERVARIX (16/04/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (108 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/2b34c98d80258bb7cbf85ca49fe76337.pdf" target="_blank"> CHAMPIX (12/02/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (118 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/d5a7bdfbc6068eb9d7f8f06520264761.pdf" target="_blank"> CIMZIA (14/09/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (71 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/a20891241272873bd7f9cf3cfb3b64ae.pdf" target="_blank"> COLOKIT (11/03/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (49 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/544dc49432d171e317e8630b9ce70d5b.pdf" target="_blank"> CYMBALTA (30/01/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (111 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/8a82ab2d46c2459b2e392b6a76df91dc.pdf" target="_blank"> EFFENTORA (16/02/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (122 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/9b87d31a3c6a02d551186d78414a8c52.pdf" target="_blank"> EFIENT (11/01/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (68 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/af34dd5913deb0f088373102d175a347.pdf" target="_blank"> ELLAONE (28/01/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (35 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/7d229693a214fbf0a30abdb05fdf0973.pdf" target="_blank"> EUCREAS (07/10/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (269 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/5312d6a472176f0bcf4f5f77beac1aad.pdf" target="_blank"> EXJADE (18/04/2007) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (111 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/8f724428a504f976c1c169541d7087cb.pdf" target="_blank"> FIRMAGON (22/02/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (33 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/5c0926ed28f2ecda17bb1ed58b0de71e.pdf" target="_blank"> GARDASIL (28/07/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (110 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/028f32a427bd2e71d6d444bdf6624eb8.pdf" target="_blank"> ILARIS (29/07/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (59 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/2876816a4f86f87df4d68b0bb2301f72.pdf" target="_blank"> INCRELEX (16/04/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (102 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/54763b2ea8e4e9bbfdfb35626a886986.pdf" target="_blank"> INSTANYL (12/05/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (107 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/6de5a83d41fee7630857466f287d5883.pdf" target="_blank"> INTELENCE (16/06/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (59 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/ae642ad1cecf0d4d187def4b1f76c869.pdf" target="_blank"> INTRINSA (07/02/2007) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (104 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/9f0bb732c0f2804f1b1442195ec66ed2.pdf" target="_blank"> ISENTRESS (10/04/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (32 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/a51b49f85f00dce5d6c8409ab0faa670.pdf" target="_blank"> JANUVIA (20/03/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (104 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/89a2040083f05c7332d9d973b0e50939.pdf" target="_blank"> KUVAN (05/01/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (43 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/3dfa641b52375a16f70ecd7956880be2.pdf" target="_blank"> LUCENTIS (16/04/2007) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (181 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/1ba32bfaa132298b8a69ff7837a7fae9.pdf" target="_blank"> MEOPA (07/01/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (113 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/1ba32bfaa132298b8a69ff7837a7fae9.pdf" target="_blank"> ANTASOL (07/01/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (113 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/1ba32bfaa132298b8a69ff7837a7fae9.pdf" target="_blank"> ENTONOX (07/01/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (113 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/1ba32bfaa132298b8a69ff7837a7fae9.pdf" target="_blank"> KALINOX (07/01/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (113 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/1ba32bfaa132298b8a69ff7837a7fae9.pdf" target="_blank"> OXYNOX (07/01/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (113 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/1659c78c990453ba9fb649fb557cc7c8.pdf" target="_blank"> METHADONE (20/04/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (40 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/d85d8c808e95d86cadb832b5b1f03871.pdf" target="_blank"> MULTAQ (26/10/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (61 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/dd1b407c197711689645b661264ed6bc.pdf" target="_blank"> MYCAMINE (07/04/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (99 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/6f706e652c66a88c60b24a74154ea075.pdf" target="_blank"> NPLATE (15/03/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (76 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/0f918228026afff3744e94e46491eed5.pdf" target="_blank"> ONGLYZA (10/11/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (104 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/257d6186e5899af8e292225ae74218e6.pdf" target="_blank"> ORENCIA (21/12/2007) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (111 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/7e16021e359f2a39cbe94cedeb9574fd.pdf" target="_blank"> OZURDEX (11/03/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (42 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/696bee13d16d00e70d7ce55c9e7b793f.pdf" target="_blank"> PRADAXA (19/12/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (48 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/8147a04ff91399107156fcc9a2051961.pdf" target="_blank"> PREVENAR (24/06/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (45 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/bf4aaa2f8ad5d04b325f1275ef4d7616.pdf" target="_blank"> PROCORALAN (11/10/2007) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (41 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/7f0e7e574210e29fb0a1e6441e3bceed.pdf" target="_blank"> QUTENZA (13/07/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (93 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/953f7c24118623017b46a6b98a73f41a.pdf" target="_blank"> RELISTOR (16/06/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (39 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/f5c4f0842f0ddc3357b46fb20eccd3cd.pdf" target="_blank"> REVLIMID (18/09/2007) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (111 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/ab056054f652c8d0d97c6a6fc0ed7da9.pdf" target="_blank"> REVOLADE (03/01/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (69 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/deaabe4616246c03cf0f0706ad0b3257.pdf" target="_blank"> ROACTEMRA (08/04/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (127 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/64cc07bf9d58e4a809fffc037f55e22c.pdf" target="_blank"> RUCONEST (17/06/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (29 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/76c487312e50e92fadc16d3f1bcd1789.pdf" target="_blank"> STELARA (18/10/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (116 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/c7fedda7d29b1f962d5d092c842f657e.pdf" target="_blank"> SUBUTEX (18/04/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (121 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/3e8e2319544e7679bb460605902ad68b.pdf" target="_blank"> SYMBICORT (31/07/2007) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (207 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/95bbd68329da6a2df5dd95c9ba203eb7.pdf" target="_blank"> THALIDOMIDE (05/10/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (113 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/bf14c8116f02a0fe22811d358019eb66.pdf" target="_blank"> TOCTINO (04/11/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (267 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/ad221305807d3b7f439ba74932816e5a.pdf" target="_blank"> TOXINE (24/02/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (116 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/be57ea650c010310a8bb78ab97ed3b2f.pdf" target="_blank"> TRACLEER (04/08/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (40 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/2f1e0a9636e72f0b546212a0428f1bb7.pdf" target="_blank"> TYSABRI (07/01/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (41 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/facd166dd792076506ee184ac4ab4575.pdf" target="_blank"> TYVERB (18/07/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (102 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/051a84e68d8ba0f3c7de41ffea31b587.pdf" target="_blank"> VALDOXAN (04/06/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (303 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/92a2bb7dbb713dbe6f48776b73f7cdd2.pdf" target="_blank"> VIMPAT (16/06/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (27 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/cac10cad1abcc3de98c1ca2b832d298c.pdf" target="_blank"> VICTOZA (18/05/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (127 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/13eecb8c24c48b7a06aec2f56ed190e3.pdf" target="_blank"> VOLIBRIS (05/01/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (33 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/058b70e6626a1f6ff4bb70cbe9d04058.pdf" target="_blank"> XARELTO (16/07/2009) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (42 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/168862dc45ad5b29721afa2403bf52b0.pdf" target="_blank"> XYREM (31/03/2008) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (43 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/afd785ddd5a7af48f229aa5b9e5658d0.pdf" target="_blank"> ZYPADHERA (28/01/2010) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (42 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/ad221305807d3b7f439ba74932816e5a.pdf" target="_blank"> TOXINE BOTULINIQUE TYPE B (24/02/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (40 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/ad221305807d3b7f439ba74932816e5a.pdf" target="_blank"> TOXINE BOTULINIQUE TYPE A (24/02/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (40 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/ad221305807d3b7f439ba74932816e5a.pdf" target="_blank"> VISTABEL (24/02/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (40 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/ad221305807d3b7f439ba74932816e5a.pdf" target="_blank"> DYSPORT (24/02/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (40 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/ad221305807d3b7f439ba74932816e5a.pdf" target="_blank"> NEUROBLOC (24/02/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (40 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/ad221305807d3b7f439ba74932816e5a.pdf" target="_blank"> XEOMIN (24/02/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (40 ko)</a>
+ </li>
+
+ <li>
+ <a class="" href="/var/ansm_site/storage/original/application/ad221305807d3b7f439ba74932816e5a.pdf" target="_blank"> BOTOX (24/02/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="" /> (40 ko)</a>
+ </li>
+
+ </ul>
+</div>
+
+</div>
+
+</div>
+ </div>
+ <div class="read_more">
+ <div class="plain_box_top_corner_left">
+ <div class="plain_box_top_corner_right">
+ <div class="plain_box_top_border"></div>
+ </div>
+ </div>
+ <div class="box_content">
+
+ <div class="links_group">
+ <ul>
+ <li><a class="read_more" href="/var/ansm_site/storage/original/application/68be570892963432b5b398192a459dc4.pdf" target="_blank" >Soumission à l’Afssaps des mesures de minimisation demandées dans le cadre d’un Plan de gestion des risques (06/03/2012) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="application/pdf" /> (34 ko)</a>
+</li>
+ <li><a class="read_more" href="/var/ansm_site/storage/original/application/3f7d33e62a51fca24394cefac76af807.pdf" target="_blank" >Submission of Risk Minimisation Plans to Afssaps (15/02/2011) <img src="/design/afssaps/images/ico_files/pdf.gif" alt="application/pdf" /> (34 ko)</a>
+</li>
+ </ul>
+</div> </div>
+ <div class="plain_box_bottom_corner_left">
+ <div class="plain_box_bottom_corner_right">
+ <div class="plain_box_bottom_border"></div>
+ </div>
+ </div>
+ </div>
+ </div>
+<div id="department">
+</div> </div>
+
+
+<div class="page_numbering">
+
+
+
+ <span class="page_button_middle" ><a href="/Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques/(offset)/2" ><img src="/design/afssaps/images/arrow_purple_left.gif" alt="" /></a></span>
+
+
+
+
+ <span class="other"><a href="/Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques/(offset)/0">1</a></span>
+ <span class="other"><a href="/Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques/(offset)/1">2</a></span>
+ <span class="other"><a href="/Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques/(offset)/2">3</a></span>
+
+ <span><a href="#" class="page_current">4</a></span>
+
+
+
+
+
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