CHMP recommends indication extension for MenQuadfi for immunisation against meningococcal disease – Sanofi

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product MenQuadfi.
The marketing authorisation holder for this medicinal product is Sanofi Winthrop Industrie.The CHMP adopted an extension to the existing indication as follows: MenQuadfi is indicated for active immunisation of individuals from the age of 6 weeks 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.

MenQuadfi is available as a fully liquid solution that does not require reconstitution and is supplied in a single-dose vial. Approval of MenQuadfi for use across a broad age range was based on a robust clinical research program, which demonstrated safety and efficacy of the vaccine from infancy to adulthood.