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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Rotarix

STN:  BL 125265
Proper Name: Rotavirus Vaccine, Live, Oral
Tradename: Rotarix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
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.
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Supporting Documents

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Related Information

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Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448