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PRAC

This page shows the latest PRAC news and features for those working in and with pharma, biotech and healthcare.

bluebird bio to restart marketing of Zynteglo in EU after previous suspension

bluebird bio to restart marketing of Zynteglo in EU after previous suspension

EMA’s safety committee PRAC has confirmed favourable risk-benefit balance of gene therapy. ... The PRAC also investigated and assessed these safety events as part of its review into Zynteglo.

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  • Changes to pharmacovigilance legislation in Europe Changes to pharmacovigilance legislation in Europe

    If the same safety concerns apply to more than one medicinal product, the competent authority may, following consultation with the Pharmacovigilance Risk Assessment Advisory Committee (PRAC), encourage the performance of a ... Among others activities,

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