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

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberCHMP/BWP/360642/2010
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 summary of product characteristics and package leaflets for plasma-derived medicinal products.


Document history

Revision 1

Current version

PDF iconAdopted guideline

 

PDF iconOverview of comments

 

PDF iconDraft guideline

In operation: 01/07/2012–present

 

Published: 14/12/2011

 

Published: 23/02/2011

First version PDF iconAdopted guideline In operation: 31/04/2004–01/07/2012


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