STN: BL 101069
Proper Name: Measles, Mumps, and Rubella Virus Vaccine, Live
Tradename: M-M-R II
Manufacturer: Merck & Co., Inc
- M-M-R II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.
May 16, 2017 Approval Letter - MMR II(PDF - 55KB)
To revise the package insert to add the terms “Henoch-Schonlein purpua” and “acute hemorrhagic edema of infancy” to the Adverse Reaction section based on post-marketing reports.
October 22, 2015 Approval Letter - MMRII(PDF - 28KB)
To update the product labeling to include changes to the Adverse Reactions section of the package insert.
December 8, 2014 Approval Letter - MMR II
To add the term “transverse myelitis” to the Adverse Reactions section of the package insert and to update the patient package insert to add the term "difficulty walking," based on post-marketing adverse event reports.
April 25, 2014 Approval Letter - MMR II
To add the term ADEM (acute disseminated encephalomyelitits) to the Adverse Reactions section of the US Prescribing Information (USPI).
January 30, 2014 Approval Letter - MMR II
To include the addition of a 2-Dimensional (2D) barcode to the MMR II® vaccine vial label, has been date stamped and issued.
May 16, 2008 Approval Letter - Measles, Mumps, and Rubella Virus Vaccine, Live
Package Insert Changes: To include epididymitis under Urogenital System in the adverse reactions section of the package insert to reflect reports received during post-marketing surveillance, and to include additional minor editorial changes.