Pharmaceuticals: Restrictions in Use and Availability
(2001; 40 pages) View the PDF document
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View the documentAlatrofloxacin mesilate
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View the documentRituximab
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View the documentTerfenadine
View the documentTilbroquinol
View the documentTolcapone
View the documentTramadol
View the documentTroglitazone
View the documentTrovafloxacin mesilate
View the documentZopiclone
Open this folder and view contentsCombination Products
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Product name:


CAS number:



3,4-Dihydroxy-4'-methyl-5 nitrobenzophenone; 3,4-Dihydroxy-5-nitrophenyl (4- methylphenyl)metahanone


Effective Date

Description of action taken
Grounds for decision


February 1999

Following overseas reports of serious and unpredictable hepatotoxicity associated with the use of the catechol-O-methyl transferase inhibitor, tolcapone (TamarR), including 3 fatalities, its registration has been withdrawn in Australia. (Reference: Australian Adverse Drug Reactions Bulletin Vol.18, No.1, February 1999.)


April 1999

The Bulgarian Drug Agency in the Ministry of Health withdrew the antiparkisonism agent, tolcapone because of serious adverse reactions worldwide. (Ref: Communication to WHO from the Bulgarian Drug Agency, Ministry of Health, Bulgaria.)


November 1998

The European Agency for the Evaluation of Medicinal Products has recommended the suspension of the marketing authorization for tolcapone. This follows several reports of severe and unpredictable hepatic reactions including fatal fulminant hepatitis. (Reference: Press release from the European Agency for the Evaluation of Medicines. 17 November 1998.)


November 1998

The State Committee on Pharmaceuticals in Iceland withdrew the marketing authorization for tolcapone due to serious adverse effects. Since then the product has been available to specialist neurologists for the treatment of severe cases of Parkinson's disease. (Reference: Communication to WHO from the State Committee on Pharmaceuticals in Iceland, 17 October 2000.)


December 1998

The State Medicines Control Agency has withdrawn from the market tablets of tolcapone. (Reference: Order of State Medicines Control Agency No. 123, 15 December 1998.)



The National Pharmaceutical Administration in the Ministry of Health has restricted the use of tolcapone to neurologists as there are concerns over reports of severe hepatotoxicity associated with the use of the drug. (Reference: Communication to WHO, 2 August 2000.)

United Kingdom

November 1998

The manufacturer of the antiparkinsonism drug, tolcapone has voluntarily withdrawn it from the market. This follows a review of the hepatotoxic effects by the European Committee for Proprietary Medicinal Products (CPMP) which found that the overall balance of risks and benefit was no longer favourable. (Reference: Communication to WHO, 30 August 2000 from the Medicines Control Agency, Department of Health, United Kingdom.)

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