title: [Comparison of the safety of the medicinal product in the European Union and the United States, tolcapone (Tasmar) -- COMT inhibitor as the analyzed example].
abstract: 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.
authors.affiliation: Katedra i Zakład Farmakologii Doświadczalnej i Klinicznej, Akademia Medyczna, ul. Krakowskie Przedmieście 26/28, 00-927 Warszawa.
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Konopka
authors.forename: Andrzej
authors.initials: A
authors.lastname: Członkowski
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000592:standards; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001577:Benzophenones / Q000008:administration & dosage / Q000009:adverse effects*; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D005062:European Union; D006801:Humans; D009596:Nitrophenols / Q000008:administration & dosage / Q000009:adverse effects*; D010300:Parkinson Disease / Q000188:drug therapy*; D011044:Poland; D000077867:Tolcapone; D014481:United States
chemical_list: D000978:Antiparkinson Agents; D001577:Benzophenones; D004791:Enzyme Inhibitors; D009596:Nitrophenols; D000077867:Tolcapone