Rotarix®
Active ingredient: Human rotavirus, live attenuated
Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
Availability: National Health Service and Private Sectors
Variation: The marketing authorisation of Rotarix® has been renewed as its benefit-risk assessment remained
positive. However its safety profile needs to be closely monitored. This is because the final results from postauthorisation safety studies have to be submitted and due to the risk of intussusception after administration of
Rotarix®. In view of this, EMA shall be kept informed about further studies and results from spontaneously
reported cases of intussusception. The CHMP decided that Rotarix® shall present yearly PSURs and an
additional 5-year renewal application.
Reference: European Medicines Agency. Rotarix. [online]. 2011Mar11 [cited 2011 Aug 23]; Available from: URL:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000639/human_med_001043.jsp&murl=menus/medicine
s/medicines.jsp&mid=WC0b01ac058001d124