Product Information

• Package Insert and Patient Information - Rotarix (PDF - 182KB)

Supporting Documents

• September 7, 2012 Approval Letter - Rotarix
  To update the package insert and patient information to reflect the results from the final analysis of the Mexico PASS data.
• June 8, 2012 Approval Letter - Rotarix
  To update the package insert and patient package insert to reflect transmission data from Twins Transmission Study Rota-052.
• February 24, 2011 Approval Letter - Rotarix
  Updated package insert and patient package insert to include "history of intussusception" as a contraindication to vaccination.
• January 13, 2011 Approval Letter - Rotarix
  Revision: Update package insert to address latex hypersensitivity
• September 17, 2010 Approval Letter - Rotarix
  Revision: Update the package insert to include changes to the Warnings and Precautions section and Post-marketing Experience section of Adverse Reactions.
• September 1, 2010 Approval Letter - Rotarix
  Includes updates to the package insert and patient information labeling to reflect the presence of Porcine Circovirus Type-1 in the vaccine.
• February 22, 2010 Approval Letter - Rotarix
  Approval to revise the contraindications section in the Package Insert.
• 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 - Rotarix
  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 - Rotarix
  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.
• Summary Basis for Regulatory Action - Rotarix
• Approval History, Letters, Reviews, and Related Documents - Rotarix

Related Information

• FDA 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.
• FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus [ARCHIVED]
  Press Release: April 3, 2008

• Update on Rotavirus Vaccine
• Update: Information on Rotarix - Labeling Revision Pertaining to Intussusception
  Questions and Answers, September 7, 2012

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