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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
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EMA Pharmacovigilance Risk Assessment Committee (PRAC)
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Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
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Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) meeting
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
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EMA confirms Janssen COVID-19 Vaccine benefits outweigh clotting risks
The EMA’s drug safety committee has concluded that the Janssen COVID-19 Vaccine is safe for continued use, so Johnson & Johnson will resume shipments to the EU.
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Highlights of the EMA’s drug safety committee April meeting
In the April meeting the Pharmacovigilance Risk Assessment Committee began two new reviews of adverse events that could be caused by COVID-19 vaccines.
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EMA clears use of COVID-19 Vaccine AstraZeneca
The EMA’s drug safety committee concluded that the vaccine is not associated with an increased risk of thromboembolic events and that its benefits still outweigh its risks.
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Danish, Norwegian and Icelandic authorities suspend use of COVID-19 Vaccine AstraZeneca
Several countries have temporarily stopped the use of the vaccine while reports of blood clots are investigated by the EMA’s pharmacovigilance committee and other authorities.
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February Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began two new reviews and wrote guidance for healthcare professionals on the potential side effects of Strimvelis, Venclyxto and Zolgensma.
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EMA highlights link between hydroxychloroquine and psychiatric disorders
The EMA recommends updating the product information for chloroquine and hydroxychloroquine after confirming a link between these medicines and psychiatric disorders.
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EMA safety committee recommends withdrawal of ulipristal acetate marketing authorisation
The EMA's PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
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EMA receives CMA application for remdesivir as a COVID-19 treatment
The European Medicines Agency (EMA) said its assessment of the conditional marketing authorisation (CMA) application will be performed under a reduced timeframe, with a decision potentially delivered in weeks.
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EMA commissions research in preparation for monitoring COVID-19 vaccines
The research will identify sources of data to monitor coverage and effectiveness, and support pharmacovigilance of COVID-19 vaccines once they are approved.
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EMA recommends updating safety information for HRT and leuprorelin
The EMA has suggested that the safety information be updated for HRT, to reflect a higher risk of breast cancer and recommends new measures for the handling of leuprorelin depot medicines.
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EMA issues statement on ibuprofen reports relating to COVID-19
The EMA has announced that reports of NSAIDs like ibuprofen making the COVID-19 coronavirus worse have no scientific basis.