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

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