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

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

Current effective version

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)

Reference Number: EMA/CHMP/20512/2023

Paediatric Addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease

Reference Number: EMA/CHMP/20507/2023

Document history

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

Draft: consultation closed Consultation dates: 31/10/2017 to 31/01/2018 Reference Number: EMA/230866/2017 Summary:

A number of new European Medicines Agancy guidelines related to clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolism (VTE) are already available [1,2,3], but recommendations are applicable only to adults. In contrast to adults, VTE in children is a rare event, but represents a significant management dilemma that requires therapeutic intervention. A paediatric addendum to the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of VTE is considered necessary to discuss and make methodological recommendations adapted to children.

Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease

Draft: consultation closed Consultation dates: 23/11/2018 to 30/06/2019 Reference Number: EMA/CHMP/763438/2017