Vaccines, Blood & Biologics
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Menveo
STN: 125300
Proper Name: Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Tradename: Menveo
Manufacturer: Novartis Vaccines and Diagnostics, Inc.
Indication:
- For active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 when administered to individuals 2 through 55 years of age.
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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.
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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