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EMA: Draft guideline on core SmPC for human fibrinogen products

05.03.2014
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for Human Fibrinogen, which is 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.

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