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Recombinant activated coagulation factor VII (rFVIIa, NovoSeven) was originally developed for the treatment of bleeding complications in haemophilia patients with allo-antibodies (inhibitors) against exogenous factor VIII or IX. In 1988, rFVIIa was used successfully in such patients for the first time. Subsequently, the efficacy and safety of rFVIIa in haemophilia patients with inhibitors has been proven in several prospective trials. A large number of case reports and results from initial clinical trials suggest that rFVIIa may also be effective in the prevention and treatment of bleeding in patients under oral anticoagulation, with liver diseases, and in patients without any pre-existing haemorrhagic diathesis. However, further clinical studies will be necessary to specify the future potential of rFVIIa.

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