Product Approval Information

Proper Name: Rotavirus Vaccine, Live, Oral
Tradename: ROTARIX
Manufacturer: GlaxoSmithKline Biologicals, License #1617

Package Insert (PDF - 281 KB) - May 2009

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Date: May 1, 2009
Revision: To update the Prescribing Information
May 1, 2009 Approval Letter

Date: February 12, 2009
Revision: To include changes to your package insert and container/carton labels to move the phrase "Do not freeze; discard if frozen".
February 12, 2009 Approval Letter

Date: April 3, 2008
Indication: Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6-24 weeks
April 3, 2008 Approval Letter
FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus
Summary Basis for Regulatory Action
Approval History, Letters, Reviews, and Related Documents