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Cisapride licences voluntarily cancelled.(Regulatory Action)(Brief Article)

WHO Drug Information

| January 01, 2005 | COPYRIGHT 1999 World Health Organization. (Hide copyright information)Copyright

United Kingdom -- The marketing authorizations for cisapride-containing products were suspended in July 2000, following advice from the Committee on Safety of Medicines (CSM), due to the risk of cardiac side effects. CSM advised that the balance of risks and benefits was no longer favourable. This advice was communicated to UK health professionals (1).

Following this suspension, a Europe-wide review of the risks and benefits of cisapride took place under the auspices of the Committee for Proprietary Medicinal Products (CPMP). On the advice of the CPMP, the European Commission decided that cisapride-containing products should be maintained within Europe but with …

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