Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolic risk in non-surgical patients

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Download document Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolic risk in non-surgical patients
Reference number EMA/CHMP/283524/2014
Status draft: consultation open
First published 16/07/2014
Last updated 16/07/2014
Consultation start date 15/07/2014
Consultation end date 15/10/2014
Email address for submissions cvswpsecretariat@ema.europa.eu

Summary

A key element in the benefit-risk assessment of medicines used for prophylaxis of venous thromboembolism (VTE) is balancing their antithrombotic effect with the risk of bleeding. Since the publication of the Committee for Medicinal Products for Human Use (CHMP) guidance on clinical investigation of medicinal products for the prophylaxis of VTE disease, a number of new European Medicines Agency (EMA) guidelines related to clinical investigation with antithrombotics have been released or are being revised. An update of the guideline on non-surgical patients, particularly related to the assessment of safety and bleeding events, is considered necessary to adapt its content to current scientific knowledge and to harmonise it with the content of the new or revised EMA guidelines related to clinical investigation with antithrombotics.