PROQUAD

STN: 125108
Proper Name: Measles, Mumps, Rubella and Varicella Virus Vaccine Live
Tradename: ProQuad
Manufacturer: Merck Sharpe & Dohme LLC
Indication:

• ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years 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

• August 21, 2023 Approval Letter - ProQuad
• February 27, 2023 Clinical Review - ProQuad
• February 27, 2023 Statistical Review - ProQuad
• February 27, 2023 Approval Letter - ProQuad
• 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