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Generic drugs and brand name products: An approach about excipients

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Detalhes bibliográficos
Resumo:In general excipients are considered to be “inert”, however in certain patients under certain circumstances some of them have demonstrated some activity, with increasing reports of adverse reactions. Generic drugs are required to have the same active substances, strength, dosage form and rout of administration as the brand name product, but excipients could be different. The excipients that have recognized action or effects should be declared on the labelling of medicines, and are listed in the Guideline products for human use.
Autores principais:Nogueira, Andreia
Outros Autores:Carvalho, Leticia; Tavares, Raquel; Ribeiro, Maximiano; Coutinho, Paula; Roque, Fátima
Assunto:Generic drugs Brand name drugs Excipients Adverse reactions Guidelines
Ano:2016
País:Portugal
Tipo de documento:artigo
Tipo de acesso:acesso aberto
Instituição associada:Instituto Politécnico da Guarda
Idioma:inglês
Origem:Repositório Institucional do Instituto Politécnico da Guarda
Descrição
Resumo:In general excipients are considered to be “inert”, however in certain patients under certain circumstances some of them have demonstrated some activity, with increasing reports of adverse reactions. Generic drugs are required to have the same active substances, strength, dosage form and rout of administration as the brand name product, but excipients could be different. The excipients that have recognized action or effects should be declared on the labelling of medicines, and are listed in the Guideline products for human use.