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PubMed1951

[Professor Comte].

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History, 19th Century↗
PubMedDate not supplied

[Comparison of the safety of the medicinal product in the European Union and the United States, tolcapone (Tasmar) -- COMT inhibitor as the analyzed example].

The authors present regulatory procedures and pharmaco-vigilance systems obligatory in the European Union and the United States. The post-approval procedures in the European Union and the United States in case of serious drug reaction (urgent safety restriction) are discussed. Worldwide implementations of the post-approval safety procedure for the tolcapone case are analyzed. Some practical information concerning tolcapone and regulatory procedures obligatory in the European Union and the United States is included.

Adverse Drug Reaction Reporting Systems↗