|Title||Update: Information on Rotarix- Labeling Revision Pertaining to Intussusception|
Tuesday, September 4, 2012
FDA update about recently approved revised prescribing information and patient labeling for the Rotarix vaccination given to infants in the United States. FDA is currently conducting a study in Mini-Sentinel’s Postlicensure Rapid Immunization Monitoring system (PRISM) to evaluate the risk of intussusception following administration of Rotarix.
- Vaccines, Blood & Biologics
- Devices and Radiologic Health