MenQuadfi - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
meningococcal group A, C, W-135 and Y conjugate vaccine
Post-authorisationHuman
On 25 June 2026, 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.
The use of this vaccine should be in accordance with available official recommendations.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
New text in bold, removed text as strikethrough.
CHMP post-authoirsation summary of positive opinion for MenQuadfi (VR-0000281377)
Adopted
Reference Number: EMADOC-1700519818-3191549
English (EN) (150.64 KB - PDF)
Pubblicato per la prima volta: