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

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Download document 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
Reference number EMA/230866/2017
Status draft: consultation open
First published 2017-10-31
Last updated 2017-10-31
Consultation start date 2017-10-31
Consultation end date 2018-01-31
Email address for submissions cvswpsecretariat@ema.europa.eu

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.