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Nonclinical Toxicology 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity The dietary administration of fluoxetine to rats and mice for 2 years at doses of up to 10 and 12 mg/kg/day, respectively [approximately 2.4 and 1.44 times, respectively, the maximum recommended human dose (MRHD) of 20 mg given to children on a mg/m2 basis], produced no evidence of carcinogenicity

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Eur Urol (2010) 58(2):2438