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Clopidogrel-haltige Arzneimittel (Plavix®, Iscover®): potentielle Wechselwirkungen mit Protonen-Pumpen-Inhibitoren (PPIs)

6. August 2009 – In einer Mitteilung vom 4. August 2009 bittet das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) um dringende Beachtung der aktualisierten Warnhinweise und Vorsichtsmaßnahmen in der Fachinformation zu Clopidogrel [Plavix] und Clopidogrel [Iscover]. Zu den Änderungen werden Rote-Hand-Briefe versendet. Hier folgend finden sie den leicht editierten und gekürzten Inhalt des Rote Hand Briefes für Plavix®.

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Information über potentielle Wechselwirkungen von Protonen-Pumpen-Inhibitoren (PPI’s) mit Clopidogrel-haltigen Arzneimitteln

7. Dezember 2009 – Sanofi Pharma Bristol-Myers Squibb informiert in Übereinstimmung mit dem Deutschen Bundesinstitut für Arzneimittel und Medizinalprodukte (BfArM) darüber, dass die Europäische Fachinformation (Summary of Product Characteristics, SPC) für Clopidogrel-Hydrogensulfat, in Verkehr gebracht als Plavix®, überarbeitet worden ist.

Danach wird in die SPC ein Warnhinweis aufgenommen,

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