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Vaccines, Blood & Biologics
ROTARIX
Proper Name: Rotavirus Vaccine, Live, Oral
Tradename: ROTARIX
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indication:
- Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6-24 weeks
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Supporting Documents
- December 30, 2009 Approval Letter - Rotarix
Revision: To include a contraindication for demonstrated history of hypersensitivity to the vaccine or any components of the vaccine, in the Warning and Precautions section - May 1, 2009 Approval Letter - Rotarix
Revision: To update the Prescribing Information. - February 12, 2009 Approval Letter
Revision: To include changes to your package insert and container/carton labels to move the phrase "Do not freeze; discard if frozen". - April 3, 2008 Approval Letter
Indication: Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6-24 weeks. - FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus
Press Release: April 3, 2008 - Summary Basis for Regulatory Action - Rotarix
GlaxoSmithKline Biologicals - Approval History, Letters, Reviews, and Related Documents - Rotarix
GlaxoSmithKline Biologicals
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