Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #548018

    IATE #1146946
    frithghníomh díobhálach in aghaidh druga Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    frithghníomh díobhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    negative Auswirkung | adverse Reaktion | Nebenwirkung
    de
    adverse reaction | adverse drug reaction | adverse reactions | adverse drug reactions | ADR
    en
    Definition response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function Reference Directive 2001/83/EC on the Community code relating to medicinal products for human use CELEX:32001L0083/EN
    effet nocif | effet indésirable
    fr
    Definition une réaction nocive et non voulue à un médicament, se produisant aux posologies normalement utilisées chez l'homme pour la prophylaxie, le diagnostic ou le traitement d'une maladie ou pour la restauration, la correction ou la modification d'une fonction physiologique Reference Directive 2001/83/CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain CELEX:32001L0083/FR
    Comment Les termes "réaction indésirable" et "effet indésirable" ne sont pas synonymes: un produit exerce un "effet" qui se manifeste par une "réaction" chez le patient.
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #569855

    IATE #2222817
    frithghníomh trom díobhálach amhrasta neamhthuartha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    mutmaßliche unerwartete schwerwiegende Nebenwirkung
    de
    suspected unexpected serious adverse reaction | serious suspected unexpected adverse drug reaction | SUSAR | suspected serious unexpected adverse drug reaction
    en
    Definition suspected adverse reaction related to an investigational medicinal product which occurs in the course of a clinical trial, and which is both unexpected and serious Reference COM-EN, based on:Voisin Consulting Life Sciences (VCLS) > resources > glossary > suspected unexpected serious adverse reaction (SUSAR) (9.3.2022)
    Comment Reports of these reactions are subject to expedited submission to health authorities.
    suspicions d'effets indésirables graves inattendus | SUSAR
    fr