New EU measures to minimize risk of meningioma with medicines containing nomegestrol or chlormadinone
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has endorsed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) in concluding that the benefits of medicines containing nomegestrol or chlormadinone outweigh the risks, provided new measures are taken to minimize the risk of meningioma.
Medicines containing nomegestrol or chlormadinone are used for gynecological and menstrual disorders, hormone replacement therapy and, at lower doses, as hormonal contraceptives.
The recommendations follow a review of available data, including post-marketing safety data and results from two recent epidemiological studies.
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