Warning on transmissible Agents

This guideline provides standard texts for warning statements on transmissible agents to be included, in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products. The original guideline (CPMP/BPWG/BWP/561/03) was adopted by CHMP in October 2003 and came into operation in May 2004. This revision affects only the introduction, where an update related to vCJD and an addition concerning albumin as excipient are now included.

Here you will get more information: "Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products".

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