Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products - Scientific guideline
This 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.
Keywords: Warning statements, plasma derived medicinal products, immunoglobulins, albumin, summary of product characteristics (SmPC), package leaflet
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Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products (PDF/170.32 KB)
Adopted
First published: 14/12/2011
Last updated: 14/12/2011
EMA/CHMP/BWP/360642/2010 -
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Overview of comments received on 'Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products' (EMA/CHMP/BWP/360642/2010 rev. ... (PDF/149.8 KB)
Adopted
First published: 14/12/2011
Last updated: 14/12/2011
EMA/CHMP/BWP/552050/2011 -
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Draft guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products (PDF/131.41 KB)
Draft: consultation closed
First published: 23/02/2011
Last updated: 23/02/2011
Consultation dates: 17/02/2011 to 30/04/2011
EMA/CHMP/BWP/360642/2010