ROTARIX
STN: BL 125265
Proper Name: Rotavirus Vaccine, Live, Oral
Tradename: ROTARIX
Manufacturer: GlaxoSmithKline Biologicals
Indication:
- 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.
Product Information
- Package Insert and Patient Information (Vial with Oral Dosing Applicator Presentation and Oral Dosing Applicator Only Presentation) - ROTARIX
- Package Insert and Patient Information (Squeezable Tube Presentation) - ROTARIX
Supporting Documents
- November 4, 2022 Approval Letter - ROTARIX
- November 12, 2019 Approval Letter - Rotarix
- Approval History, Letters, Reviews, and Related Documents - Rotarix
- Supporting Documents older than three years - Rotarix