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GSK Says European Medicine Agency Committee Issues Positive Recommendation for Menveo Single-Vial Presentation
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GSK Says European Medicine Agency Committee Issues Positive Recommendation for Menveo Single-Vial Presentation
Sep 24, 2024 5:12 AM

07:16 AM EDT, 09/24/2024 (MT Newswires) -- GSK (GSK) said Tuesday the European Medicine Agency's Committee for Medicinal Products for Human Use has recommended approval for use of a single-vial, fully liquid presentation of Menveo vaccine against invasive meningococcal disease.

The single-vial presentation, if approved, will be licensed for immunization of children from two years of age, adolescents, and adults, GSK said.

The committee's recommendation is based on positive results from two Phase IIb trials, which showed that the new formulation has comparable immunogenicity, safety, and tolerability to the existing lyophilized/liquid version.

The final approval decision from the European Commission is expected by November 2024.

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