Vaccines, Blood & Biologics
-
VAQTA
STN: BL 103606
Proper Name: Hepatitis A Vaccine, Inactivated
Tradename: VAQTA
Manufacturer: Merck & Co, Inc, License #0002
Indications:
- For active immunization against disease caused by hepatitis A virus in persons 12 months of age and older.
-
Supporting Documents
- July 10, 2012 Summary Basis for Regulatory Action-VAQTA (PDF - 201KB)
July 16, 2012 Approval Letter - VAQTA
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
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
For the immunization of persons two years of age and older.August 11, 2005 Approval Letter - VAQTA
Lowering the age indication for VAQTA from two years to 12 months of age.Clinical Review - Hepatitis A Vaccine, Inactivated (PDF - 252KB)
-
-
-
