SARS-CoV-2 Infection Clinical Trial
Official title:
General Drug Use-Result Study of Evusheld Intramuscular Injection Set (Treatment and Prevention of Symptomatic Disease Caused by SARS-CoV-2 Infection)
To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.
To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese. The investigation will be conducted as the addtional pharmacovigilance activitiy specified in the Japan Risk Management Plan (J-RMP) of Evusheld in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act). ;
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