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Share this article Share this article NEW BRUNSWICK, N.J., April 20, 2021 /PRNewswire/  Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Medicines Agency s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the Company s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company s COVID-19 vaccine. As a result, Johnson & Johnson will update its COVID-19 vaccine Summary of Product Characteristics and Package Leaflet to include important information on the diagnosis and management of this very rare adverse event. Healthcare professionals will be alerted to the signs and symptoms of thromboembolism with thrombocytopenia, as well as the appropri

Paul stoffelsNone of the janssen pharmaceutical companiesPharmacovigilance risk assessment committeeUs centers for diseaseEuropean commissionDrug administrationAdvisory committee on immunization practicesJanssen pharmaceutical companiesJanssen pharmaceutical companies of johnsonExchange commissionCompanies of johnsonEuropean unionEuropean medicines agencyEuropean commission onProduct characteristicsPackage leaflet