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Erlotinib (Tarceva): Anpassung der Indikation an theragenomische Voraussetzungen

19. Januar 2016 – Die folgende Meldung steht stellvertretend für die Entwicklung von Therapieansätzen im Zeitalter der theragenomischen und personalisierten Medizin. Es handelt sich um eine Präzisierung der Fachinformation zu Erlotinib (Tarceva), welche die Anwendung von Erlotinib (Tarceva) in der First-Line Erhaltungstherapie auf Patienetinnen / Patienten mit aktivierenden Mutationen im epidermalen Wachstumsfaktorrezeptor (EGFR),

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Erlotinib [Tarceva]: Erhöhtes Risiko für gastrointestinale Perforation, bullose und exfoliative Hautveränderungen einschliesslich sehr seltener Verdachtsfälle von Stevens-Johnson-Syndrom (SJS) und Toxischer Epidermaler Nekrolyse (TEN), und okulare Störungen

17. April 2008 – Gemäss einer Mitteilung der Swissmedic hat Roche Pharma (Schweiz), in Zusammenarbeit mit Swissmedic, am 15. April 2009 über neue wichtige sicherheitsrelevante Informationen und die Aktualisierung des Sicherheitsprofils von Erlotinib [Tarceva] informiert. Danach sind dringend folgende Warnhinweise und Vorsichtsmassnahmen neu zu beachten:

Gastrointestinale Perforation:  0.1 –

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Informationen über das Auftreten von Magen-Darm-Perforationen im Zusammenhang mit der Anwendung von Erlotinib [Tarceva]

25. Mai 2009 – Das Deutsche Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) bittet in einer Mitteilung von heute dringend um die Beachtung der aktualisierten Warnhinweise und Vorsichtsmassnahmen in der Fachinformation zu Erlotinib [Tarceva]. Zu den aktuellen Änderungen wird ein Rote-Hand-Brief zu Tarceva versendet.

Zusammengefasst wird dabei festgehalten:

1.

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