Clinical requirements for non replacement therapy in haemophilia A and B - Scientific guideline

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

Keywords: Haemophilia, non-replacement therapies, prophylactic treatment

Current effective version

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

Adopted Reference Number: EMA/CHMP/BPWP/518080/2024

First version

Draft guideline on the clinical requirements for non replacement therapy in haemophilia A and B

Draft: consultation closed Consultation dates: 01/11/2023 to 30/04/2024 Reference Number: EMA/CHMP/453562/2023