(2001; 76 pages)
Continued suspension for tolcapone
European Union -Tolcapone (Tasmar®) was marketed in August 1997 for the treatment of Parkinson disease in 100 mg and 200 mg film-coated tablets.
In November 1998, the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) recommended suspension of tolcapone following reports of severe hepatotoxicity. Subsequently, the suspension was renewed in October 2000.
In September 2001, evidence was reviewed and the benefit/risk profile re-assessed and the CPMP have recommended renewal of the suspension for a further year pending the results of an ongoing prospective trial on comparable treatments.
Reference: EMEA Press Release, 26 September 2001. http://www.emea.eu.int