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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
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002