Tolcapone (Tasmar) is indicated for the adjunctive treatment of Parkinson’s disease. In August 1997 the European Commission granted Roche Registration Limited a marketing authorisation for tolcapone (Tasmar). The scientific committee of the European Agency for the Evaluation of Medicinal Products suspended Roche’s marketing authorisation for tolcapone (Tasmar) in 1998 due to increasing concerns over reports of severe hepatotoxicity. The suspension order was later renewed in the years 1999 and 2000. On 19 September 2001, having reviewed the evidence submitted by the Marketing Authorisation Holder and having re-assessed the benefit/risk profile of the medicinal product, and with a prospective trial over comparable treatment in progress, the committee has recommended renewal of the suspension of the marketing authorisation for a further year. This suspension could be reevaluated when the results of the prospective study become available.

Reference:

EMEA Press Release CPMP/2986/01, 26 Sept 2001.

Available from URL: http://www.csmwm.org/safety_issues.htm