ROTARIX

STN:  BL 125265
Proper Name: Rotavirus Vaccine, Live, Oral
Tradename: ROTARIX
Manufacturer: GlaxoSmithKline Biologicals SA
Indication:

• ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9). ROTARIX is approved for use in infants 6 weeks up to 24 weeks of age.

Product Information

• Package Insert and Patient Information (Oral Dosing Applicator Presentation) - ROTARIX

Supporting Documents

• September 25, 2026 Approval Letter - ROTARIX 
• April 30, 2026 Approval Letter - ROTARIX 
• 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

Related Information

• FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus - ARCHIVED
• Update on Rotavirus Vaccine - ARCHIVED
• Update: Information on Rotarix - Labeling Revision Pertaining to Intussusception - ARCHIVED