EN PL

EMA: Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products

08.01.2015
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).