Information Letter on oral ketoconazole-containing medicinal products (Nizoral® tablets): Suspension of marketing authorisation due to serious liver damage
2013.08.22
Active substance: ketoconazole
After an EU-wide review of the risk of hepatotoxicity under ketoconazole for treatment of fungal infections, the EMA recommends the suspension of the marketing authorisation for Nizoral® tablets (oral ketoconazole-containing medicinal products) in the EU.
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