Bufexamac-haltige Arzneimittel zur topischen Anwendung: Widerruf der Zulassungen in der EU wegen ungünstigen Nutzen-Risiko-Verhältnisses

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27. April 2010 – Die Bewertung des BfArM, dass Bufexamac-haltige Arzneimittel zur topischen Anwendung in den zugelassenen Indikationen ein insgesamt ungünstiges Nutzen-Risiko-Verhältnis aufweisen und die Zulassungen deshalb zu widerrufen sind, wurde durch den Ausschuss für Humanarzneimittel (CHMP) der Europäischen Arzneimittelagentur  (EMEA) auf seiner April-Sitzung bestätigt.

Bufexamac-haltige Arzneimittel wurden in der Dermatologie und Proktologie zur Behandlung von chronischen Ekzemen und Dermatosen sowie bei Entzündungen in der Analregion angewendet. Nach einer Anhörung des BfArM nach dem Stufenplan im November 2009 hatten die pharmazeutischen Unternehmer im Januar 2010 auf ihre Zulassungen für Bufexamac-haltige Arzneimittel in Deutschland verzichtet. Das EU-Gemeinschaftsrecht sieht vor, dass im Falle einer Maßnahme in einem EU-Mitgliedsland wegen eines ungünstigen Nutzen-Risiko-Verhältnisses eine Risikobewertung durch den CHMP für sämtliche in der EU zugelassenen Arzneimittel mit den betroffenen Wirkstoffen erfolgt. Die Empfehlung des CHMP wird nun der EU-Kommission zur Entscheidung vorgelegt.

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Joseph Gut - thasso 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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