Need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease - Scientific guideline
Table of contents
This document addresses the need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease.
Keywords: Venous thromboembolism, treatment, prophylaxis, major bleeding, guidelines, anticoagulant, CHMP
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Overview of comments received on draft Paediatric Addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease (EMA/CHMP/763438/2017) (PDF/477.07 KB)
First published: 10/02/2023
EMA/CHMP/20512/2023 -
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Paediatric Addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease (PDF/378.13 KB)
First published: 10/02/2023
EMA/CHMP/20507/2023
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Concept paper on the need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease (PDF/121.09 KB)
Draft: consultation closed
First published: 31/10/2017
Last updated: 31/10/2017
Consultation dates: 31/10/2017 to 31/01/2018
EMA/230866/2017 -
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Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease (PDF/191.08 KB)
Draft: consultation closed
First published: 23/11/2018
Consultation dates: 23/11/2018 to 30/06/2019
EMA/CHMP/763438/2017