SOCIAL QUESTIONS|health|pharmaceutical industry · TRADE|marketing|marketing|market approval
- cothromaíocht idir rioscaí agus tairbhí Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- cothromaíocht sochair-riosca Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
- ga
- benefit-risk balance | risk-benefit balance | risk/benefit balance
- en
- Definition evaluation, carried out during the authorisation procedure, of the positive therapeutic effects of the medicinal product in relation to any risk relating to the quality, safety or efficacy of the medicinal product as regards patients' health or public health Reference "COM-EN, based on:Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use"
- rapport bénéfice/risque | rapport bénéfices/risques
- fr
- Definition évaluation des effets thérapeutiques positifs du médicament au regard du risque Reference "Directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain (version consoliée), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0083:20110721:FR:HTML [8.10.2012]"