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Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus


EMA/CHMP/BWP/723009/2014 Committee for Medicinal Products for Human Use (CHMP)

Document Type:
Refelction Paper
• Clinical experience with HEV infections and transfusion-associated infections: How serious are HEV infections and which patient populations may be particularly at risk? • HEV detection and epidemiology of HEV in blood/plasma donations • Do serum antibodies against HEV significantly neutralise? • Latest experience from studies on inactivation/removal of HEV: Which steps are effective to remove / inactivate HEV? Which model viruses can be used to assess that? Do we need more virus validation data?

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