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GSK announces EMA to review the regulatory application of Shingrix

GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix for the prevention of shingles. The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering an alternative option for physicians, pharmacists and other healthcare professionals who administer vaccinations. The current presentation of the vaccine consists of a lyophilised, powder, antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The new presentation has the same composition as the reconstituted vaccine and the submission is based on data demonstrating comparability between the two.

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