Reasons for Nizoral Withdrawal from the Market and Reflections on Risk Management

Abstract

Abstract: This article reviews the recent domestic and international activities of ketoconazole regulation, analyzes systematically the reasons of Nizoral (ketoconazole tablets) withdrawal from aspects of drug adverse reaction, clinical usage, risk management and benefit-risk balance, and provides a reference case to further elucidates the mechanism of drugs out of market and the role of risk management in the drug life cycle.

Key words: ketoconazole, Nizoral, ketoconazole tablets, withdrawal

CLC Number:

WANG Dan, WU Gui-zhi, NIE Xiao-lu. Reasons for Nizoral Withdrawal from the Market and Reflections on Risk Management[J]. Chinese Journal of Pharmacovigilance, 2014, 11(9): 550-553.

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