Meeting of the Pharmacovigilance Risk Assessment Committee

Most important news of the meeting of the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency organized on 02-05.09. 2013.

The Pharmacovigilance Risk Assessment Committee (PRAC) has issued recommendations concerning two medicinal products and commenced one new reassessment.

PRAC has recommended to restrict use of short-acting beta-agonists in obstetrics and also recommends to suspend marketing authorization of the medicinal product for intravenous nutrition of immature newborns NUMETA G13%E until composition of the medicinal product is modified and approved.
Further on, PRAC has commenced reassessment of the risk-benefit ratio in the orally used medicinal products containing bromocriptine.

Report of the meeting of the Pharmacovigilance Risk Assessment Committee.

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