Tolcapone will be made available with the restricted indication in patients “who failed to respond to or are intolerant of other COMT inhibitors”.
This is following a meeting of the European Committee for Proprietary Medicinal Products in April 2004 which recommended lifting the suspension of the Marketing Authorisation for tolcapone. This followed review of the available clinical evidence including evidence of increased efficacy for tolcapone over entacapone in the control of motor fluctuations in patients with advanced Parkinson’s disease.
Check summary of product characteristics before prescribing this drug.
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