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MenQuadfi
Published
Product name
MenQuadfi
Active ingredient
Quadrivalent meningococcal (groups A, C, Y, W135) polysaccharide tetanus toxoid conjugate vaccine
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
MenQuadfi (meningococcal (groups A, C, Y, W) polysaccharide tetanus toxoid conjugate vaccine) was approved for the following therapeutic use:
MenQuadfi is indicated for active immunisation for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y. The use of MenQuadfi should be in accordance with official recommendations.
How this medicine works
Invasive meningococcal disease (IMD) is caused by the bacterium N. meningitidis, a gram negative diplococcus found exclusively in humans. The presence of bactericidal anti-capsular meningococcal antibodies has been associated with protection from IMD. MenQuadfi induces the production of bactericidal antibodies specific to the capsular polysaccharides of N. meningitides serogroups A, C, W, and Y.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of MenQuadfi was considered favourable for the therapeutic use approved.
Sponsor