WHO Drug Information Vol. 15, No. 3 & 4, 2001
(2001; 76 pages) View the PDF document
Table of Contents
View the documentWHO Drug Information
Open this folder and view contentsPersonal Perspectives
Open this folder and view contentsReports on Individual Drugs
Open this folder and view contentsQuality Assurance Issues
Open this folder and view contentsCurrent Topics
Open this folder and view contentsGeneral Information
Close this folderRegulatory and Safety Matters*
View the documentInfliximab and congestive heart failure
View the documentInfliximab: warning of opportunistic infections
View the documentBrimonidine ophthalmic drops: accidental ingestion
View the documentP-Glycoprotein and drug interaction
View the documentNonacog alfa: intensive surveillance
View the documentTenofovir disoproxil fumarate approved for HIV infection
View the documentCiprofloxacin hydrochloride for inhalation anthrax
View the documentDTPa and limb swelling
View the documentNitrofurantoin and peripheral neuropathy
View the documentContinued suspension for tolcapone
View the documentMMR vaccine and idiopathic thrombocytopenic purpura
View the documentNew communications and networking unit at EMEA
Open this folder and view contentsATC/DDD Classification
Open this folder and view contentsRegulatory Information
View the documentRecommended International Nonproprietary Names (rec. Inn): List 46
View the documentSelected WHO Publications of Related Interest
 

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

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