Clinical and non-clinical evaluation during the consultation procedure on medicinal substances contained in drug-eluting (medicinal-substance-eluting) coronary stents

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Current effective version

Adopted guideline

Reference numberCHMP/EWP/110540/07
Published30/05/2008
Effective from01/12/2008
KeywordsDrug eluting stents, non-clinical safety, clinical safety
DescriptionThis document addresses the clinical and non-clinical aspects of the evaluation of ancillary medicinal substances contained in a drug-eluting coronary stents.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/12/2008–present


Published: 24/07/2008


Published: 22/03/2007


Published: 23/02/2006


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