Tredaptive
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 EU/1/08/459/003 |
| 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 recall | 2 |
| BASG reference number | INS-640.001-0642 |
Further inquiry note
Page last modified:
12/07/2022