Recall | Medicines | 22/01/2013

The marketing authorization holder has informed its supplied customers that preliminary results from the HPS2-THRIVE study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) failed to show any additional benefit of Tredaptive in reducing serious vascular events. The study also found a significant increase in the incidence of some serious non-fatal adverse events in the patient group that received Tredaptive. Consequently, the risk-benefit ratio can no longer be considered positive and a recall of all in-market batches from pharmacies and wholesalers and all physician samples will be issued.

Name of the medicinal product TREDAPTIVE 1000mg/20mg Tabletten mit veränderter Wirkstofffreisetzung
Marketing authorisation number(s) EU/1/08/459/002
Marketing authorisation holder Merck Sharp & Dohme Ltd., UK

Vertrieb und Durchführung Rückruf:
Merck Sharp & Dohme Ges.m.b.H., AT
Batch number(s) Alle Chargen
Classification of the recall2
BASG reference number INS-640.001-0642

Further inquiry note