Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product

    #572602

    IATE #3502882
    frithghníomh díobhálach amhrasta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    mutmaßliche Nebenwirkung
    de
    suspected adverse reaction | SAR
    en
    Definition adverse reaction in respect of which there is at least a reasonable possibility of there being a causal relationship between a medicinal product and the event Reference COM-Terminology Coordination, based on: Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
    Comment See also: adverse reaction
    effet indésirable présumé
    fr
    Definition effet indésirable pour lequel un lien de causalité entre l’événement et le médicament ne peut être exclu Reference COM-Document interne: ENTR/2008/80076/02/02
  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