Gaois

Cóip statach de shonraí a easpórtáiltear ó IATE ó am go chéile atá sa chnuasach seo. Níor cheart glacadh leis gurb ionann i gcónaí an t-eolas a thugtar faoi iontráil anseo agus a bhfuil sa leagan reatha den iontráil ar IATE. Is féidir an leagan reatha sin a cheadú ach cliceáil ar an nasc atá ar thaobh na láimhe deise ag barr gach iontrála. Breis eolais »

5 thoradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #687637

    IATE #3636811
    frithghníomh díobhálach amhrasta neamh‑thromchúiseach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Cuirfidh sealbhóirí údaraithe margaíochta faisnéis faoi na frithghníomhartha díobhálacha amhrasta neamh‑thromchúiseacha uile dá dtarlaíonn san Aontas agus i dtríú tíortha isteach i mbunachar sonraí Eudravigilance go leictreonach laistigh de 90 lá tar éis an lae a fuair sealbhóir an údaraithe margaíochta lena mbaineann eolas faoin teagmhas.' Tagairt "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    non-serious suspected adverse reaction
    en
    Sainmhíniú "any untoward medical occurrence that is not a serious suspected adverse reaction" Tagairt "COM-Terminology Coordination, based on: EMA. 'Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products' (24.7.2023) (Rev 2). 28 July 2017 EMA/873138/2011 Rev 2*"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product

    #641589

    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
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #675524

    IATE #858182
    frithghníomh díobhálach amhrasta tromchúiseach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Cuirfidh sealbhóirí údaraithe margaíochta faisnéis faoi na frithghníomhartha díobhálacha amhrasta neamh‑thromchúiseacha uile dá dtarlaíonn san Aontas agus i dtríú tíortha isteach i mbunachar sonraí Eudravigilance go leictreonach laistigh de 90 lá tar éis an lae a fuair sealbhóir an údaraithe margaíochta lena mbaineann eolas faoin teagmhas.' Tagairt "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    serious suspected adverse reaction | suspected serious adverse reaction
    en
    Sainmhíniú any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect Tagairt "EMA. 'Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products' (24.7.2023) (Rev 2). 28 July 2017 EMA/873138/2011 Rev 2*"
    Nóta The characteristics/consequences should be considered at the time of the reaction to determine the seriousness. For example, life-threatening refers to a reaction in which the patient was at risk of death at the time of the reaction; it does not refer to a reaction that hypothetically might have caused death if more severe.
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #639123

    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 | SUSAR | suspected serious unexpected adverse drug reaction | serious suspected 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.
    SUSAR | suspicions d'effets indésirables graves inattendus
    fr
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688184

    IATE #3639830
    tuairisc faoi fhrithghníomh díobhálach amhrasta Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs ... áiritheoidh siad, tríd na modhanna chun faisnéis a bhailiú agus i gcás inar gá trí bhearta leantacha a dhéanamh i leith tuarascálacha faoi fhrithghníomhartha díobhálacha amhrasta, go ndéanfar gach beart is iomchuí chun aon táirge íocshláinte bitheolaíoch a shainaithint go soiléir ar táirge íocshláinte é a dhéantar a oideasú ...' Tagairt "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    suspected adverse reaction report
    en