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October 22, 2021
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Ketoconazole drugs removed from shelves



The National Medicines Agency (ANM) asked pharmacies across Romania to stop selling ketoconazole-containing medicines, following European Commission’s call for the removal of these products from EU national markets, ANM President Marius Savu told Mediafax yesterday. The European Commission asked the withdrawal of all ketoconazole-containing medicines, used to treat fungal infections. This summer, the European Medicines Agency recommended that the marketing authorizations of oral ketoconazole-containing medicines should be suspended throughout the EU, because the risk of liver injury is greater than the benefits in treating fungal infections. There are five companies in Romania producing ketoconazole-containing medicines, i.e. Arena, Terapia (Nizoral), Helcor, Magista and Slavia.

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