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EMA confirms safety of plasma and urine-derived medicines from Zika virus contamination
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  • Publication:2016/10/18

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed that plasma or urine-derived medicines are safe for use in Europe.

The agency confirmed that patients using such medicines are not at an increased risk of getting the Zika infection.

Plasma-derived medicines are manufactured from human blood and urine-derived products are manufactured from pooled human urine.

Body fluids used in the production of these medicines might be sourced from regions where the Zika virus is prevalent.

"The agency confirmed that patients using such medicines are not at an increased risk of getting the Zika infection."

The plasma-derived medicines are used to treat and prevent serious diseases and include coagulation factors and immunoglobulins, while urine-derived products include certain hormone-based treatments and urokinase products.

Results from assessments were conducted by the agency in the EU Member States and confirmed that the manufacturing processes used for such medicines successfully inactivates or removes the virus, therefore there is no risk of it contaminating the final product.

Manufacturing processes such as solvent / detergent method, pasteurisation (liquid heat inactivation) and virus filtration are used to inactivate viruses.

The CHMP said that no additional safety measures such as the testing or exclusion of certain plasma donors and screening of urine donors or donations, or the deferral of donors returning from affected areas are considered unnecessary.