EMA - Publication of the Guideline on the clinical requirements for non-replacement therapy in haemophilia A and B

After a consultation phase between November 2023 and April 2024, the EMA finally published its Guideline on the clinical requirements for non-replacement therapy in haemophilia A and B. This guideline describes the main clinical data needed to support an application for a marketing authorisation for non-replacement therapy for use in prevention of bleeding in patients with haemophilia A and/or haemophilia B More information on the EMA Website.

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2025-02-04
DOI
https://doi.org/10.58079/138p1
Primary Topic
Hemophilia Treatment and Research
Type
article
Field-Weighted Citation Impact
0.00
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article

EMA - Publication of the Guideline on the clinical requirements for non-replacement therapy in haemophilia A and B

Industrias Culturais (Universidade de Coimbra)
Hemophilia Treatment and Research
article

EMA - Publication of the Guideline on the clinical requirements for non-replacement therapy in haemophilia A and B

article en

Abstract

After a consultation phase between November 2023 and April 2024, the EMA finally published its Guideline on the clinical requirements for non-replacement therapy in haemophilia A and B. This guideline describes the main clinical data needed to support an application for a marketing authorisation for non-replacement therapy for use in prevention of bleeding in patients with haemophilia A and/or haemophilia B More information on the EMA Website.

Industrias Culturais (Universidade de Coimbra)
Openalex Percentile: Top 35%
Hemophilia Treatment and Research
DOIOpen Access PDFOpenAlex
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EMA - Publication of the Guideline on the clinical requirements for non-replacement therapy in haemophilia A and B · Industrias Culturais (Universidade de Coimbra) (2025) | TGRS Research Map | TGRS