RotaTeq
STN: BL 125122
Proper Name: Rotavirus Vaccine, Live, Oral, Pentavalent
Tradename: RotaTeq
Manufacturer: Merck Sharp & Dohme Corp
Indication:
- For the prevention of rotavirus gastroenteritis caused by the types G1, G2, G3, G4, and G9 for use in infants 6 weeks to 32 weeks of age.
Product Information
Supporting Documents
- August 14, 2020 Approval Letter - RotaTeq
- February 22, 2017 Summary Basis for Regulatory Action - RotaTeq
- January 26, 2017 Statistical Review - Rota Teq
- February 23, 2017 Clinical Review - Rota Teq
- February 23, 2017 Approval Letter - RotaTeq
To expand the indication to include prevention of rotavirus gastroenteritis caused by type G9 - Supporting Documents older than three years - RotaTeq
Related Information
- RotaTeq (Rotavirus Vaccine) Questions and Answers - ARCHIVED
- FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants - ARCHIVED
Press Release: February 3, 2006