STN: BL 125265
Proper Name: Rotavirus Vaccine, Live, Oral
Manufacturer: GlaxoSmithKline Biologicals
- For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9), for use in infants 6 weeks to 24 weeks of age.
- April 25, 2016 Approval Letter - Rotarix
To change the product labeling in accordance with the guidance for industry issued on December 2, 2014, titled, “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.
- February 27, 2015 Approval Letter - Rotarix
To include product labeling to indicate that the diluent in oral applicators should be stored at 2-8°C or at controlled room temperature up to 25°C instead of the current recommendation for storage at 20-25°C.
- Approval History, Letters, Reviews, and Related Documents - Rotarix
- Supporting Documents older than three years - Rotarix