STN: BL 103606
Proper Name: Hepatitis A Vaccine, Inactivated
Manufacturer: Merck & Co, Inc, License #0002
- For active immunization against disease caused by hepatitis A virus in persons 12 months of age and older.
- July 10, 2012 Summary Basis for Regulatory Action-VAQTA (PDF - 201KB)
July 16, 2012 Approval Letter - VAQTA[ARCHIVED]
Support concomitant administration of VAQTA® with Diptheria, Tetanus, acelluar Pertussis and Haemophilus influenzae type b vaccines in 12 to 23 months old children.
March 30, 2010 Approval Letter - VAQTA[ARCHIVED]
Revisions to the PI to comply with the Physician’s Labeling Rule format
- March 25, 2010 Summary Basis For Regulatory Action-VAQTA (PDF - 171KB)
March 29, 1996 Approval Letter - VAQTA[ARCHIVED]
For the immunization of persons two years of age and older.
August 11, 2005 Approval Letter - VAQTA[ARCHIVED]
Lowering the age indication for VAQTA from two years to 12 months of age.
Clinical Review - Hepatitis A Vaccine, Inactivated(PDF - 252KB)