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  1. SOCIAL QUESTIONS|health|pharmaceutical industry · TRADE|marketing|marketing|market approval

    #648540

    IATE #3542049
    cothromaíocht idir rioscaí agus tairbhí Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    cothromaíocht sochair-riosca Tagairt "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
    Risiko-Nutzen-Bilanz | Nutzen-Risiko-Profil | Nutzen-Risiko-Verhältnis
    de
    benefit-risk balance | risk-benefit balance | risk/benefit balance
    en
    Sainmhíniú 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 Tagairt "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
    Sainmhíniú évaluation des effets thérapeutiques positifs du médicament au regard du risque Tagairt "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]"