Product Information

• Package Insert - Menveo (PDF - 281KB)

Supporting Documents

• April 1, 2011 Approval Letter-Menevo
  To include the reevaluated immunogenicity data due to a transcription error that led to the revision of V59P13 and V59P18 immunogenicity data in the original submission (125300/7).
• January 28, 2011 Approval Letter - Menevo
  To include safety and immunogenicity data to support use in children 2 through 10 years of age.
• November 4, 2010 Approval Letter - Menveo
  Revisions to the directions for product reconstitution in the package insert.
• March 18, 2010 Approval Letter - Menveo
  To revise the instructions for use on the packing carton and vials to reflect, MenA Lyophilized Conjugate Component should be reconstituted with the MenCYW-135 Liquid Conjugate Component to form MENVEO and that neither component should be used alone.
• Feburary 19, 2010 Approval Letter - Menveo
  Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 when administered to individuals 11 through 55 years of age.
• Approval History, Letters, Reviews, and Related Documents - Menveo Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
• Summary Basis for Regulatory Action - Menveo (BLA/STN # 125300/49) (PDF - 136KB)
  To include data regarding persistence of meningococcal antibodies in adolescents through 21 months following first vaccination with MENVEO.
• Summary Basis for Regulatory Action - Menveo (BLA/STN # 125300/7) (PDF - 80KB)
  To include the reevaluated immunogenicity data due to a transcription error that lead to the revision of V59P13 and V59P18 immunogenicity data in the original submission (125300_0).
• Summary Basis for Regulatory Action - Menveo (PDF - 156KB)
  Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 when administered to individuals 11 through 55 years of age.
• SBRA - Menveo (PDF - 251KB)
  Additional Indication Sought Under This BLA Supplment: Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 when administered to individuals 2 through 10 years of age.

Related Information

• MENVEO® [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] - Untitled Letter

Contact FDA