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6 thoradh

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

    #572602

    IATE #3502882
    frithghníomh díobhálach amhrasta Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    mutmaßliche Nebenwirkung
    de
    suspected adverse reaction | SAR
    en
    Sainmhíniú 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 Tagairt 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
    Nóta See also: adverse reaction
    effet indésirable présumé
    fr
    Sainmhíniú effet indésirable pour lequel un lien de causalité entre l’événement et le médicament ne peut être exclu Tagairt COM-Document interne: ENTR/2008/80076/02/02
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #548018

    IATE #1146946
    frithghníomh díobhálach in aghaidh druga Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    frithghníomh díobhálach Tagairt 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
    Sainmhíniú 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 Tagairt Directive 2001/83/EC on the Community code relating to medicinal products for human use CELEX:32001L0083/EN
    effet nocif | effet indésirable
    fr
    Sainmhíniú 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 Tagairt 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
    Nóta 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.
  3. SOCIAL QUESTIONS|health · SOCIAL QUESTIONS|health|pharmaceutical industry

    #526875

    IATE #137521
    frithghníomh díobhálach neamhthuartha Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    unerwartete Nebenwirkung
    de
    Nóta Term defined -- Term defined --
    unexpected adverse reaction
    en
    Sainmhíniú adverse reaction [ IATE:1146946 ], the nature, severity or outcome of which is not consistent with the summary of product characteristics [ IATE:3535729 ] Tagairt Directive 2001/83/EC on the Community code relating to medicinal products for human use CELEX:02001L0083*/EN
    effet indésirable inattendu
    fr
    Sainmhíniú Activité imprévue d'un médicament dans un domaine autre que celui pour lequel il est administré, qui est gênante, dangereuse ou limite l'utilisation du médicament et dont la nature ou la gravité ne correspond à aucune de ses propriétés pharmacologiques connues. Tagairt Grand dictionnaire terminologique (Office de la langue française, 2000), http://www.granddictionnaire.com
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #526874

    IATE #137520
    frithghníomh trom díobhálach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    schwerwiegende Nebenwirkung
    de
    Nóta Term defined -- Term defined --
    serious adverse reaction
    en
    Sainmhíniú adverse reaction [ IATE:1146946 ] that is life-threatening; results in death or a persistent or significant disability or incapacity; manifests itself as a congenital anomaly/birth defect; or, in the case of the treatment of humans, requires inpatient hospitalisation or prolongation of existing hospitalisation or, in the case of the treatment of animals, results in permanent or prolonged signs in the animals treated Tagairt EP-EN Terminology, based on:- Directive 2001/83/EC on the Community code relating to medicinal products for human use, CELEX:32001L0083/EN - Directive 2001/82/EC on the Community code relating to veterinary medicinal products, CELEX:32001L0082/EN
    effet indésirable grave
    fr
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #569855

    IATE #2222817
    frithghníomh trom díobhálach amhrasta neamhthuartha Tagairt 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
    Sainmhíniú 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 Tagairt COM-EN, based on:Voisin Consulting Life Sciences (VCLS) > resources > glossary > suspected unexpected serious adverse reaction (SUSAR) (9.3.2022)
    Nóta Reports of these reactions are subject to expedited submission to health authorities.
    suspicions d'effets indésirables graves inattendus | SUSAR
    fr
  6. SOCIAL QUESTIONS|health|pharmaceutical industry

    #582130

    IATE #3543181
    frithghníomh trom díobhálach neamhthuartha Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    unerwartete schwerwiegende Nebenwirkung
    de
    Sainmhíniú schwerwiegende Nebenwirkung, deren Art, Schweregrad oder Ergebnis nicht den Referenzinformationen zur Unbedenklichkeit entspricht Tagairt COM-Internes Dokument SANCO-2012-80155-00-01 (Verordnung über klinische Prüfungen mit Humanarzneimitteln)
    unexpected serious adverse reaction
    en
    Sainmhíniú serious adverse reaction [ IATE:137520 ] the nature, severity or outcome of which is not consistent with the reference safety information Tagairt Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:32014R0536/EN
    effet indésirable grave et inattendu
    fr
    Sainmhíniú 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 Tagairt COM-Document interne: SANCO-2012-80155-00-04BR>Règlement relatif aux essais cliniques de médicaments à usage humain