EMA: Draft guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor-IX products

This guideline describes the information to be included in the summary of product characteristics (SmPC) for human plasma-derived and recombinant coagulation factor-IX products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).