Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products
|Keywords||Human plasma derived coagulation factor IX products, recombinant coagulation factor IX products, haemophilia B|
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).
In operation: 01/04/2015–present
In operation: 01/12/2012–01/04/2015
|First version||Adopted guideline||In operation: 01/12/2000–01/12/2012|