Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648662

    IATE #3543181
    frithghníomh trom díobhálach neamhthuartha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    unerwartete schwerwiegende Nebenwirkung
    de
    Definition schwerwiegende Nebenwirkung, deren Art, Schweregrad oder Ergebnis nicht den Referenzinformationen zur Unbedenklichkeit entspricht Reference COM-Internes Dokument SANCO-2012-80155-00-01 (Verordnung über klinische Prüfungen mit Humanarzneimitteln)
    unexpected serious adverse reaction
    en
    Definition "serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information" Reference "Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC"
    effet indésirable grave et inattendu
    fr
    Definition "effet indésirable grave [ IATE:137520 ] dont la nature, la gravité ou l'issue ne concorde pas avec les informations de référence relatives à la sécurité" Reference COM-Document interne: SANCO-2012-80155-00-04BR>Règlement relatif aux essais cliniques de médicaments à usage humain