Product Approval Information
Proper Name: Zoster Vaccine, Live
Tradename: Zostavax
Manufacturer: Merck & Co., Inc, License #0002
- Package insert (Frozen) (PDF -166 KB) - June 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.
Date: November 18, 2008
Revised Package Insert: To include changes consisted of updates to the Post-Marketing Section with the addition of “rash” based on post-marketing reports, reinserting the word “sterile” to Section 11 (Description) of the label, and replacing “lyophilized preparation” with “suspension” in the Highlights section of the label
Date: June 18, 2008
Revised Package Insert: To include changes to the package insert and patient product information for the frozen formulation.
Date: June 18, 2008
Revised Package Insert: To include changes to the package insert and patient product information for the refrigerator stable formulation
Date: July 6, 2007
Revised Package Insert: To include a statement in the package insert regarding concomitant administration of ZOSTAVAX with inactivated influenza vaccine
Date: May 25, 2006
Indication: Prevention of herpes zoster (shingles) in individuals 60 years of age and older when administered as a single-dose
- May 25, 2006 Approval Letter
- Patient Information (PDF - 40 KB)
- Patient Information (Text)
- Questions and Answers
- FDA News Release