Acessibilidade / Reportar erro

Avaliação dos efeitos da Resolução RDC 17 sobre fitoterápicos de registros antigos

The Brazilian market of phytomedicine from registered medicines previously to the 1995 was evaluated qualitatively as expression of the set of old products in market. Nine old registered commercialy pharmacy products of São Paulo contend exclusively extracts of plants or mixed with synthetic drugs. Aspects of content, labeling and informations for use had been evaluated; in complement, one searched to evaluate the course of the toxicidade studies and effectiveness. All the nine medicines had presented problems in the labeling and informations for use, being distinguished lacks it of the following information: mechanisms of action (100%), used part (78%), superdosages (67%), cares with old people and children (56%), cares of conservation (22%) and risks of the products (11%). In relation to the studies of security guard and effectiveness, only two laboratories (2/9) informed the course of the same ones. It is verified therefore that the medicines of old register, for diverse reasons, meet outside of the demanded legal standards.


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