Core summary of product characteristics for human fibrinogen products - Scientific guideline

This document describes the information to be included in the summary of product characteristics for human fibrinogen. It applies to medicinal products indicated for the treatment and prophylaxis of bleeding in patients with congenital hypo-, dys- or afibrinogenaemia with bleeding tendency and as a complementary therapy to management of uncontrolled severe haemorrhage in acquired hypofibrinogenaemia.

Keywords: Human fibrinogen, congenital hypofibrinogenaemia, acquired hypofibrinogenaemia, congenital dysfibrinogenaemia, congenital afibrinogenaemia