PROQUAD
STN: 125108
Proper Name: Measles, Mumps, Rubella and Varicella Virus Vaccine Live
Tradename: ProQuad
Manufacturer: Merck Sharpe & Dohme Corp
Indication:
- Simultaneous vaccination against MMRV in children 12mo to 12 yrs of age.
Product Information
- Package Insert - Refrigerator-Stable Formulation - ProQuad
- Package Insert - Frozen Formulation - Recombinant Human Albumin (RHA) - ProQuad
- Package Insert - Frozen Formulation - Human SerumAlbumin (HSA) - ProQuad
- Package Insert (Frozen) - ProQuad
- Package Insert (Refrigerated) - ProQuad
- Patient Information (Refrigerated) -ProQuad
- Patient Information (Frozen)- ProQuad
Supporting Documents
- April 13, 2021 Approval Letter - ProQuad
- September 15, 2020 Approval Letter - PROQUAD
- January 22, 2019 Approval Letter - PROQUAD
- October 23, 2018 Approval Letter - PROQUAD
- May 16, 2017 Approval Letter - PROQUAD
Updated Letter: The original letter included the incorrect term Vaccinia in the product name when the correct name is Measles, Mumps, Rubella and Varicella Virus Vaccine Live. The replacement letter corrects that error. - March 15, 2017 Summary Basis for Regulatory Action - ProQuad
- March 15, 2017 Approval Letter - PROQUAD
- Supporting Documents older than three years - PROQUAD