Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients
| Current effective version |
|
| Reference number | EMA/CPMP/EWP/6235/04 Rev. 1 |
| Published | 29/11/2016 |
| Effective from | 01/06/2017 |
| Keywords | Prevention, venous thromboembolism, bleeding, non-surgical patients, cancer, chemotherapy |
| Description | This document provides guidance for the evaluation of new medicinal products in the primary prophylaxis of venous thrombo-embolic risk in the non-surgical setting. |
Document history
Revision 1 Current version
|
| Published: 29/11/2016
Effective from: 01/06/2017
Published: 291//2016
Published: 16/11/2015 Published: 16/07/2014 |
| First version |
 Adopted guideline
| In operation: 30/11/2006 - 01/06/2017 |
Related content
- Directive 2001/83/EC
- Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery
- ICH E1 Extent of population exposure to assess clinical safety
- ICH E4 Dose-response information to support drug registration
- ICH E9 Statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- Investigation of drug interactions
- Application with 1) Meta-analyses 2) One pivotal study