GSK: EMA examines new Shingrix presentation
(CercleFinance.com) - GSK announces that the European Medicines Agency (EMA) has agreed to review the regulatory application for a pre-filled syringe presentation of Shingrix, its recombinant shingles (herpes zoster) vaccine.
This new presentation simplifies administration by eliminating the need to reconstitute vials before injection.
It retains the same composition as the current vaccine, and is based on comparability data.
Following US FDA approval on 8 January 2025, GSK is also exploring submissions in other markets.
Shingrix has been approved in the EU since 2018 for adults aged 50 and over, and since 2020 for adults at increased risk aged 18 and over.
Copyright (c) 2025 CercleFinance.com. All rights reserved.
This new presentation simplifies administration by eliminating the need to reconstitute vials before injection.
It retains the same composition as the current vaccine, and is based on comparability data.
Following US FDA approval on 8 January 2025, GSK is also exploring submissions in other markets.
Shingrix has been approved in the EU since 2018 for adults aged 50 and over, and since 2020 for adults at increased risk aged 18 and over.
Copyright (c) 2025 CercleFinance.com. All rights reserved.