tetano
Editor, Senior Moderator
This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.
Issued: Thursday 21 July 2011, London UK
GlaxoSmithKline (GSK) announced today that the European Medicines Agency?s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an update to the product label for the H1N1 influenza vaccine, Pandemrix.
Based on a review of currently available information on an increased number of reported cases of narcolepsy among children and adolescents in a small number of European countries, the CHMP confirmed that the overall benefit-risk balance for Pandemrix remains positive.
The CHMP recommended that the product information for Pandemrix should be updated to state that in persons under 20 years of age, Pandemrix should only be used if the recommended seasonal trivalent influenza vaccine is not available, and if immunisation against H1N1 is still needed, for example, in persons at risk of the complications of infection. This revision does not apply to adults over 20 years of age.
The label revision concludes an ongoing review of data by the CHMP, including the preliminary findings of an epidemiological study of narcolepsy and pandemic vaccines across a network of research and public health institutions (VAESCO) in eight European countries, as well as epidemiological data from Finland and Sweden. The preliminary findings of the VAESCO study confirmed a signal in Finland, but do not enable conclusions to be drawn in other countries, where vaccination coverage with Pandemrix was lower. Epidemiological studies in Finland and Sweden suggest an association between Pandemrix vaccination and narcolepsy in children and adolescents in those countries. The CHMP stated that further research is necessary in order to determine the potential role of genetic, environmental and other factors in raising the risk of narcolepsy.
http://www.4-traders.com/GLAXOSMITH...n-regulatory-update-on-Pandemrix%99-13717702/
Issued: Thursday 21 July 2011, London UK
GlaxoSmithKline (GSK) announced today that the European Medicines Agency?s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an update to the product label for the H1N1 influenza vaccine, Pandemrix.
Based on a review of currently available information on an increased number of reported cases of narcolepsy among children and adolescents in a small number of European countries, the CHMP confirmed that the overall benefit-risk balance for Pandemrix remains positive.
The CHMP recommended that the product information for Pandemrix should be updated to state that in persons under 20 years of age, Pandemrix should only be used if the recommended seasonal trivalent influenza vaccine is not available, and if immunisation against H1N1 is still needed, for example, in persons at risk of the complications of infection. This revision does not apply to adults over 20 years of age.
The label revision concludes an ongoing review of data by the CHMP, including the preliminary findings of an epidemiological study of narcolepsy and pandemic vaccines across a network of research and public health institutions (VAESCO) in eight European countries, as well as epidemiological data from Finland and Sweden. The preliminary findings of the VAESCO study confirmed a signal in Finland, but do not enable conclusions to be drawn in other countries, where vaccination coverage with Pandemrix was lower. Epidemiological studies in Finland and Sweden suggest an association between Pandemrix vaccination and narcolepsy in children and adolescents in those countries. The CHMP stated that further research is necessary in order to determine the potential role of genetic, environmental and other factors in raising the risk of narcolepsy.
http://www.4-traders.com/GLAXOSMITH...n-regulatory-update-on-Pandemrix%99-13717702/