Bayers Entwicklungspartner Janssen Research & Development, LLC hat bei der US-amerikanischen Gesundheitsbehörde FDA (Food and Drug Administration) einen Antrag auf Zulassung für den oralen Gerinnungshemmer Xarelto® (Rivaroxaban) zur Anwendung bei Kindern gestellt. Der Antrag erstreckt sich auf zwei pädiatrische Indikationen:
• die Behandlung von venösen Thromboembolien (VTE) sowie Prophylaxe von deren Rezidiven bei pädiatrischen Patienten unter 18 Jahren nach mindestens 5 Tagen initialer parenteraler Antikoagulationstherapie
• sowie die Thromboseprophylaxe nach der Fontan-Operation bei Patienten ab zwei Jahren mit angeborener Herzerkrankung.
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• die Behandlung von venösen Thromboembolien (VTE) sowie Prophylaxe von deren Rezidiven bei pädiatrischen Patienten unter 18 Jahren nach mindestens 5 Tagen initialer parenteraler Antikoagulationstherapie
• sowie die Thromboseprophylaxe nach der Fontan-Operation bei Patienten ab zwei Jahren mit angeborener Herzerkrankung.
Nach einer Zulassung wäre Xarelto der bislang einzige in den USA für Kinder zugelassene orale Faktor Xa-Inhibitor. In beiden potenziellen Indikationen jfnd Upyypcw mwl Wafyy ynu Qhtkzqhqgtjlvd oxhdthq awjvdm – dpxinhni lih fmuam mzyixw Gpaqpnmpdb koso ctn Gcagtqnjn.
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