Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/BWP/360642/2010 Rev. 1
Published14/12/2011
Effective from01/07/2012
KeywordsWarning statements, plasma derived medicinal products, immunoglobulins, albumin, summary of product characteristics (SmPC), package leaflet
DescriptionThis document provides standard texts for warning statements on transmissible agents to be included in the summary of product characteristics and package leaflets for plasma-derived medicinal products


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/07/2012–present


Published: 14/12/2011


Published: 23/02/2011

First versionAdopted guidelineIn operation: 30/04/2004–01/07/2012


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