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PRAC

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

FDA rejects Allergan’s uterine fibroid drug over safety concerns

FDA rejects Allergan’s uterine fibroid drug over safety concerns

The findings were backed up by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that Esmya may have contributed to the development of some cases of serious liver injury.

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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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