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Bevacizumab [Avastin] in den USA zur Behandlung von Brustkrebs zurückgezogen

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24. Dezember 2010 – Swissmedic teilte per 17. Dezember 2010 mit, dass sie durch die amerikanische Heilmittelbehörde FDA  darüber informiert wurde,  dass  die Zulassung von Bevacizumab [Avastin] zur Behandlung von Brustkrebs in den USA zurückgezogen werden soll (siehe dazu auch die Blog-Post hier).

Die Zulassung für dieses Anwendungsgebiet wurde in den USA 2008 in einem beschleunigten Verfahren erteilt,

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Bevacizumab [Avastin] verursacht Hypersensitivitäts- und Infusionsreaktionen

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20. Mai 2010 – In Absprache mit der Swissmedic informiert Roche Pharma ein Risiko für Überempfindlichkeits- und Infusionsreaktionen bei Bevacizumab [Avastin]-behandelten Patienten.

Diese Reaktionen manifestieren sich wie folgt (während der Infusion oder bis zu 2 Tage später): Dyspnol/Atmungsschwierigkeiten, Flushing/Rötung/Ausschlag, Hypo- oder Hypertonie, Sauerstoffentsättigung, Schmerzen im Brustraum,

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