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Diane® 35 und Generika: Positives Nutzen-Risiko-Verhältnis bei spezifischen Patientengruppen

Aktualisierte Meldung des BfArM vom 31. Mai 2013 – Im Februar 2013 hatte das BfArM darüber informiert, dass der Ausschuss für Risikobewertung im Bereich Pharmakovigilanz (PRAC) der Europäischen Arzneimittelagentur in seiner Februar Sitzung ein Risikobewertungsverfahren zu dem Arzneimittel Diane® 35 (enthält 2mg Cyproteronacetat und 35 µg Ethinylestradiol) und entsprechenden Generika gestartet hat (Diane® 35 und Generika: Europäisches Risikobewertungsverfahren gestartet).

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Französische Arzneimittelaufsicht verbietet Antibabypille Diane 35

01-02-2013  – Zehntausende französische Frauen müssen ihre Pille wechseln. Nebenwirkungen des Bayer-Präparats «Diane 35» sollen für mindestens vier Todesfälle verantwortlich sein. Die französische Arzneimittelaufsicht zog jetzt die Reissleine.

Ein häufig als Antibabypille verschriebenes Akne-Medikament von Bayer wird in Frankreich wegen möglicher tödlicher Nebenwirkungen verboten. Das Präparat «Diane 35» sowie Generika dürften nur noch in einer Übergangszeit von drei Monaten vertrieben werden,

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