Recombinant activated Factor VII (rFVIIa; eptacog alpha [activated], NovoSeven) is currently used for the management of a subgroup of haemophilia patients with inhibitors to Factors VIII or IX, and is under investigation as an adjuvant therapy for critical bleeding from other causes, including trauma. rFVIIa has a mode of action founded on physiological coagulation processes, and causes localised haemostasis at injury sites, both spontaneous and traumatic, with the capacity to correct the systemic coagulopathy associated with massive blood loss and its management. This review charts the development of rFVIIa as a new and potent adjuvant therapy for severe bleeding and coagulopathy caused by blunt trauma, where it is reported to produce rapid and significant haemostasis, reducing transfusion requirements and improving clinical outcome.