Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April 2021
EventHumanPharmacovigilance
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Date
- Dé Máirt, 20 Aibreán 2021, All day
Áit
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
This extraordinary meeting is organised in the context of the evaluation of a safety signal withJcovden (previously COVID-19 Vaccine Janssen) relating to cases of thromboembolic events.
The aim of the meeting is to issue a recommendation on the evaluation of the signal including possible regulatory action, which usually consists of an update to the product information.
The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines.