EMA starts review of sodium oxybate in alcohol dependence
Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
The European Commission granted CMA in December 2021 for use of Nuvaxovid in individuals aged 18 and over, and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in March 2022
In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year
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