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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, August 2021 europeanpharmaceuticalreview
August 10, 2021
The EMA’s drug safety committee (PRAC) recommends updating risks of Janssen COVID-19 Vaccine, though the benefit-risk balance remains unchanged.
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021 europeanpharmaceuticalreview
July 14, 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021 europeanpharmaceuticalreview
June 17, 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.
Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) meeting europeanpharmaceuticalreview
May 11, 2021
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
EMA confirms Janssen COVID-19 Vaccine benefits outweigh clotting risks europeanpharmaceuticalreview
April 22, 2021
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.
J&J to restart Covid-19 vaccine shipment in Europe pharmaceutical-technology
April 22, 2021
Johnson & Johnson (J&J) is set to resume shipment of the single-shot Covid-19 vaccine in Europe following a positive review by the European Medicines Agency (EMA).
Highlights of the EMA’s drug safety committee April meeting europeanpharmaceuticalreview
April 14, 2021
In the April meeting the Pharmacovigilance Risk Assessment Committee began two new reviews of adverse events that could be caused by COVID-19 vaccines.
EMA review concludes AstraZeneca Covid-19 vaccine is “safe and effective” pharmaceutical-technology
March 19, 2021
The European Medicines Agency (EMA) has concluded that the AstraZeneca/Oxford University Covid-19 vaccine is “safe and effective” after an investigation into a potential link between the vaccine and blood clots in a small number of patients.
February Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights europeanpharmaceuticalreview
February 19, 2021
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.
EMA highlights link between hydroxychloroquine and psychiatric disorders europeanpharmaceuticalreview
December 01, 2020
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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