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 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

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: 30/04/2004–01/07/2012


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