EMA – Revision 3 of the Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products
The EMA published its Third revision of the Guideline on core SmPC 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).
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vroby (19 octobre 2024). EMA – Revision 3 of the Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products. ELSIBI. Consulté le 11 janvier 2026 à l’adresse https://doi.org/10.58079/12j9r





