Ein Beratergremium(Cardiovascular and Renal Drugs Advisory Committee) der US-amerikanischen Gesundheitsbehörde FDA (Food and Drug Administration) wird am 8. September 2011 den Zulassungsantrag für Rivaroxaban in den USA zur Prophylaxe gegen Schlaganfälle sowie systemische Embolien außerhalb des Zentralnervensystems (ZNS) bei Patienten mit nicht-valvulärem Vorhofflimmern diskutieren. Mitarbeiter der FDA, die in die Vorbereitung des Beratertreffens eingebunden waren, haben geäußert, dass die Daten der ROCKET AF-Studie keine gleichartige Wirksamkeit von Rivaroxaban im Vergleich zu Warfarin zeigen würden, wenn Warfarin in adäquater Weise verabreicht worden wäre. Ferner weisen die FDA-Mitarbeiter darauf hin, dass die vorgesehenen Patienteninformationen für einen Wechsel von Rivaroxaban zu Warfarin nicht ap ucksa vwfbohlsuu Hfetrp voonfmlvzk yyruyz euxif.
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