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PRAC November 2021: updates on COVID-19 vaccines and conclusion of safety signal for Imbruvica

During its November 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has made un update on COVID-19 vaccines and concluded a safety signal for Imbruvica.

PRAC October 2021 – Nomegestrol containing products and chlormadinone containing products and update on COVID-19 vaccines

During its October 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of meningioma risk with nomegestrol- and chlormadinone-containing medicines. The PRAC also has reviewed data on venous thromboembolism and immune thrombocytopenia with COVID-19 vaccines.

PRAC August 2021 – Recommendation and review of safety issues related to COVID-19 vaccines

During its August 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended updating the product information of COVID-19 Vaccine Janssen. Furthermore, the PRAC continues to closely review reports of Guillain-Barré syndrome with Vaxzevria and discussed other safety issues occurring after vaccination against COVID-19.

PRAC May 2021 – Conclusions and reviews of safety signals related to COVID-19 vaccines

During its May 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.

PRAC April 2021 – Conclusions and additional review on Vaxzevria (AstraZeneca’s COVID-19 vaccine), and new investigations on COVID-19 Vaccine Janssen

During its April 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded on very rare cases of unusual blood clots with low blood platelets reported with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) and started reviewing a safety signal of capillary leak syndrome in patients vaccinated Vaxzevria. Furthermore, the PRAC is also investigating thromboembolic events reported following vaccination with COVID-19 Vaccine Janssen.

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