Gaois

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4 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #601818

    IATE #137520
    frithghníomh trom díobhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    schwerwiegende Nebenwirkung
    de
    Comment Term defined -- Term defined --
    serious adverse reaction
    en
    Definition "adverse reaction that is life-threatening" Reference "COM-Terminology Coordination,, 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- Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products"
    Comment It 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
    effet indésirable grave
    fr
  2. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #602357

    IATE #156927
    teagmhas trom díobhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    schwerwiegendes unerwünschtes Ereignis
    de
    Comment Term defined -- Term defined --
    serious adverse event
    en
    Definition any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect, is life-threatening or results in death Reference "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"
    incident indésirable grave | effet indésirable grave | événement indésirable grave
    fr
    Definition effet indésirable associé à la consommation de drogues ou de substances psychoactives non réglementées qui entraîne la mort, met la vie en danger, nécessite un traitement et/ou une hospitalisation d'urgence ou provoque un handicap ou une incapacité importants ou durables Reference Observatoire européen des drogues et des toxicomanies (OEDT), [18.9.2017]
    Comment Term defined -- Term defined --
  3. SOCIAL QUESTIONS|health

    #643647

    IATE #3516710
    iarmhairt thromchúiseach neamh-inmhianaithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Definition iarmhairt neamh-inmhianaithe as a leanann éagumas feidhme sealadach nó buan, míchumas, ospidéalú, éanormalachtaí ó bhroinn nó baol láithreach báis nó bás Reference "Rialachán (CE) Uimh. 1223/2009 ó Pharlaimint na hEorpa agus ón gComhairle an 30 Samhain 2009 maidir le táirgí cosmaideacha, CELEX:32009R1223/GA [6/2/2012]"
    ernste unerwünschte Wirkung
    de
    Definition eine unerwünschte Wirkung, die zu vorübergehender oder dauerhafter Funktionseinschränkung, Behinderung, einem Krankenhausaufenthalt, angeborenen Anomalien, unmittelbarer Lebensgefahr oder zum Tod führt Reference "Verordnung (EG) Nr. 1223/2009 über kosmetische Mittel, Artikel 2 Nummer 1 Buchstabe p, konsolidierte Fassung vom 31.7.2022 (16.8.2022)"
    serious undesirable effect | SUE
    en
    Definition undesirable effect of a cosmetic product which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death Reference "COM-Term. Coord., based on:Regulation (EC) No 1223/2009 on cosmetic products, article 2(1)(p), CELEX:32009R1223/EN [6/2/2012]"
    effet indésirable grave
    fr
    Definition un effet indésirable entraînant une incapacité fonctionnelle temporaire ou permanente, un handicap, une hospitalisation, des anomalies congénitales, un risque vital immédiat ou un décès Reference "Règlement (CE) n o 1223/2009 relatif aux produits cosmétiques, article 2, paragraphe 1, point p), CELEX:32009R1223/FR [6.2.2012]"
  4. 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