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

Opinion

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.

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CHMP post-authoirsation summary of positive opinion for MenQuadfi (VR-0000281377)

Adopted Reference Number: EMADOC-1700519818-3191549

Key facts

• Name of medicine:
  MenQuadfi
• EMA product number:
  EMEA/H/C/005084
• Active substance:
  • Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid
• International non-proprietary name (INN) or common name:
  meningococcal group A, C, W-135 and Y conjugate vaccine
• Therapeutic area (MeSH):
  Meningitis, Meningococcal
• Anatomical therapeutical chemical (ATC) code:
  J07AH08
• Marketing authorisation holder:
  Sanofi Winthrop Industrie
• Date of opinion:
  25/06/2026
• Status:
  Positive