STN: BL 103926
Proper Name: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined
Manufacturer: Sanofi Pasteur Inc, License #1725
- For active immunization against invasive meningococcal disease caused by Neisseria meningiditis serogroups A, C, Y, and W-135. Menomune – A/C/Y/W-135 vaccine is approved for use in persons 2 years of age and older.
April 6, 2016 Approval Letter - (Menomune - A/C/Y/W -135(PDF - 28KB)
To include changes to the product labeling.
October 3, 2013 Approval Letter - Menomune - A/C/Y/W - 135
To include revisions to the NDC and the Package Insert, 2D Barcode additions and modification of the single dose detachable label.
October 19, 2012 Approval Letter - Menomune-A/C/Y/W-135[ARCHIVED]
To include updated information in the Dosage and Administration section of the package insert.
June 13, 2012 Approval Letter - Menomune-A/C/Y/W-135[ARCHIVED]
To update the package insert by changing the wording from a "suspension" to a clear "solution" based on the current master specification.
January 9, 2009 Approval Letter - Menomune-A/C/Y/W-135