ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.
ROTARIX | FDA - U.S. Food and Drug Administration
Rotarix approval page indicated 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.
US FDA approves new fully liquid presentation of GSK’s ROTARIX …
2022年11月7日 · ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.
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 and up to 24...
ROTARIX (human rotavirus, live, attenuated, oral vaccine) is indicated for: active immunization of infants from the age of 6 weeks for the prevention of gastroenteritis caused by circulating rotavirus strains (see 7 WARNINGS AND PRECAUTIONS and 14 CLINICAL TRIALS).
Statistical Review and Evaluation - Rotarix | FDA
Product: Rotarix, Live Attenuated Human Rotavirus (HRV) Vaccine, Oral (GSK) Indication: Prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, and non-G1...
Rotarix (live attenuated rotavirus vaccine) | GSK Public UK
Information on Rotarix (live attenuated rotavirus vaccine) for members of public including summary of product characteristics and patient information leaflet
Rotarix™ significantly reduced severe rotavirus gastroenteritis ... - GSK
The New England Journal of Medicine (NEJM) today published the first study demonstrating that Rotarix™, GlaxoSmithKline’s rotavirus vaccine, significantly prevented severe rotavirus gastroenteritis during the first year of life in African babies.
FDA says Healthcare Providers can resume use of Rotarix ... - GSK
GlaxoSmithKline (NYSE: GSK) announced that the Food and Drug Administration (FDA) has determined that U.S. healthcare practitioners can resume the use of Rotarix (Rotavirus Vaccine, Live, Oral), effective immediately.
Rotavirus Vaccine Information Statement | CDC - Centers for …
Almost all babies who get rotavirus vaccine will be protected from severe rotavirus diarrhea. Another virus called “porcine circovirus” can be found in one brand of rotavirus vaccine (Rotarix). This virus does not infect people, and there is no known safety risk.
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