Efalizumab [Raptiva] Zulassung sistiert

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Die Zulassung von Efalizumab [Raptiva] wird in der Schweiz zum 1. Mai 2009 sistiert. Es sollen bis auf weiteres keine neuen Patienten mehr auf Raptiva eingestellt werden.

Raptiva ist ein immunsuppressiv wirksamer, humanisierter monoklonaler Antikörper, der 2004 in der Schweiz zur Behandlung von erwachsenen Patienten mit mittelschwerer bis schwerer Psoriasis vom Plaque-Typ zugelassen wurde.

Wie die europäische Zulassungsbehörde EMA vertritt Swissmedic die Auffassung, dass das Nutzen-/Risiko-Verhältnis in der zugelassenen Indikation aufgrund von neuen Sicherheitsbedenken ungünstig geworden ist. So wurde unter anderem nach dem 25. Februar 2009 ein weiterer Fall einer infektiösen Erkrankung des Zentralnervensystems beobachtet. Folgerichtig müssen bis spätestens zum 30. April 2009 alle derzeit mit Raptiva behandelten Patienten unter spezialärztlicher Kontrolle auf eine Alternativtherapie umgestellt sein.

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thassodotcom Professor in Pharmakologie und Toxikologie. Experte in theragenomischer und personalisierter Medizin und individualisierter Arzneimittelsicherheit. Experte in Pharmako- und Toxiko-Genetik. Experte in der klinischen Sicherheit von Arzneimitteln, Chemikalien, Umweltschadstoffen und Nahrungsinhaltsstoffen.

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