GSK Shingrix new prefilled syringe presentation accepted for review by EMA
London: GSK plc has announced that the European Medicines Agency (EMA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK's Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster).
The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient 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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