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PRAC

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

MHRA suspends new prescriptions of fibroid drug Esmya

MHRA suspends new prescriptions of fibroid drug Esmya

In December, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the treatment for abnormal bleeding in women with uterine fibroids after four 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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