Product Approval Information
Proper Name: Rotavirus Vaccine, Live, Oral
Tradename: ROTARIX
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Package Insert (PDF - 409 KB) - Approved: April 3, 2008
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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