RotaTeq
STN: BL 125122
Proper Name: Rotavirus Vaccine, Live, Oral, Pentavalent
Tradename: RotaTeq
Manufacturer: Merck & Co, Inc
Indication:
- For prevention of rotavirus gastroenteritis in infants 6 weeks to 32 weeks of age caused by types G1, G2, G3, G4, and G9.
Product Information
Supporting Documents
February 22, 2017 Summary Basis for Regulatory Action - RotaTeq (PDF - 66KB)January 26, 2017 Statistical Review - Rota Teq (PDF - 331KB)February 23, 2017 Clinical Review - Rota Teq (PDF - 339KB)February 23, 2017 Approval Letter - RotaTeq (PDF - 48KB)
To expand the indication to include prevention of rotavirus gastroenteritis caused by type G9Supporting Document Older Than Three Years - RotaTeq
Related Information
RotaTeq (Rotavirus Vaccine) Questions and Answers FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants - ARCHIVED
Press Release: February 3, 2006FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
Related Links
Postmarketing Monitoring of Intussusception After RotaTeq™ Vaccination
March 16, 2007 - Centers for Disease Control and Prevention