{"id":639,"date":"2014-12-10T16:17:47","date_gmt":"2014-12-10T14:17:47","guid":{"rendered":"http:\/\/www.hausarzt-muehlheim.de\/?p=639"},"modified":"2014-12-10T16:21:31","modified_gmt":"2014-12-10T14:21:31","slug":"zulassungen-von-80-generischen-arzneimitteln-ruhen-wegen-gefaelschter-zulassungsstudien-aus-indien","status":"publish","type":"post","link":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/zulassungen-von-80-generischen-arzneimitteln-ruhen-wegen-gefaelschter-zulassungsstudien-aus-indien\/","title":{"rendered":"Zulassungen von 80 generischen Arzneimitteln ruhen wegen gef\u00e4lschter Zulassungsstudien aus Indien"},"content":{"rendered":"

Eine Inspektion der indischen Firma GVK Biosciences, die sich selbst als Asiens f\u00fchrende Auftragsforschungsorganisation bezeichnet, f\u00f6rderte M\u00e4ngel bei allen inspizierten Bio\u00e4quivalenzstudien von Generika zutage, sodass Verdacht auf vors\u00e4tzliche F\u00e4lschung besteht.<\/p>\n

Wegen der Schwere und Systematik der Manipulation akzeptieren europ\u00e4ische Beh\u00f6rden auch die anderen von GVK Biosciences zwischen 2008 und 2014 durchgef\u00fchrten Bio\u00e4quivalenzstudien nicht mehr als Basis von Zulassungen.<\/p>\n

Mehrere europ\u00e4ische Arzneimittelbeh\u00f6rden haben bereits begonnen, das Ruhen von Zulassungen anzuordnen. In Deutschland hat das Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte (BfArM) 176 nationale Zulassungen von Generika von insgesamt 28 Firmen \u00fcberpr\u00fcft und soeben das Ruhen der Zulassung von 80 Generika von 16 Firmen angeordnet.<\/p>\n

Diese Pr\u00e4parate sind ab sofort nicht mehr verkehrsf\u00e4hig. Sie d\u00fcrfen also in der gesamten Handelskette (Hersteller, Gro\u00dfhandel, Apotheken) nicht mehr verkauft werden.<\/p>\n

Liste der betroffenen Arzneimittel<\/a><\/p>\n

Wenn Sie eines der Arzneimittel von einer der betreffenden Firmen verschrieben bekommen haben, so wenden Sie sich bitte wegen eines Umtauschs an Ihre Apotheke. <\/p>\n

Bei R\u00fcckfragen steht Ihnen unsere Praxis zur Verf\u00fcgung!<\/p>\n","protected":false},"excerpt":{"rendered":"

Eine Inspektion der indischen Firma GVK Biosciences, die sich selbst als Asiens f\u00fchrende Auftragsforschungsorganisation bezeichnet, f\u00f6rderte M\u00e4ngel bei allen inspizierten Bio\u00e4quivalenzstudien von Generika zutage, sodass Verdacht auf vors\u00e4tzliche F\u00e4lschung besteht. Wegen der Schwere und Systematik der Manipulation akzeptieren europ\u00e4ische Beh\u00f6rden auch die anderen von GVK Biosciences zwischen 2008 und 2014 durchgef\u00fchrten Bio\u00e4quivalenzstudien nicht mehr als […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","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":"","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-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":"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":""},"mobile":{"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":""}},"_FSMCFIC_featured_image_caption":"","_FSMCFIC_featured_image_nocaption":"","_FSMCFIC_featured_image_hide":"","footnotes":""},"categories":[10],"tags":[],"class_list":["post-639","post","type-post","status-publish","format-standard","hentry","category-rote-hand-informationen"],"_links":{"self":[{"href":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/wp-json\/wp\/v2\/posts\/639","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/wp-json\/wp\/v2\/comments?post=639"}],"version-history":[{"count":2,"href":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/wp-json\/wp\/v2\/posts\/639\/revisions"}],"predecessor-version":[{"id":642,"href":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/wp-json\/wp\/v2\/posts\/639\/revisions\/642"}],"wp:attachment":[{"href":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/wp-json\/wp\/v2\/media?parent=639"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/wp-json\/wp\/v2\/categories?post=639"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hausarzt-muehlheim.de\/index.php\/wp-json\/wp\/v2\/tags?post=639"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}