EMA – Revision 3 of the Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products
Year: 2024
Type: other
Abstract: 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).
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12j9r
Author: Vroby
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6917692860
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