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 »

3 thoradh

  1. SOCIAL QUESTIONS|health · AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health

    #650422

    IATE #3549999
    oideasú seachlipéid Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Verschreibung außerhalb der Zulassung
    de
    off-label prescribing
    en
    Sainmhíniú prescription of a medication in a manner different from that approved Tagairt "Randall S. Stafford. Regulating Off-Label Drug Use — Rethinking the Role of the FDA. N Engl J Med 2008; 358:1427-1429, http://www.nejm.org/doi/full/10.1056/NEJMp0802107 [15.10.2015]"
    Nóta "i.e. for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. See also:- off-label medicine (related) [ IATE:2201460 ]- off-label approval (related) [ IATE:164216 ]- off-label use [ IATE:927305 ]"
    prescription hors RCP
    fr
    Sainmhíniú prescription d'un médicament d'une manière qui n'est pas conforme au résumé des caractéristiques du produit, notamment le mauvais usage ou l'abus grave du médicament Tagairt "COM-FR, d'après:Directive 2000/37/CE modifiant le chapitre VI bis de la directive 81/851/CEE concernant le rapprochement des législations des États membres relatives aux médicaments vétérinaires, CELEX:32000L0037/FR"
    Nóta RCP pour résumé des caractéristiques du produit
  2. SOCIAL QUESTIONS|health|health policy · SOCIAL QUESTIONS|health|medical science · SOCIAL QUESTIONS|health|pharmaceutical industry

    #638496

    IATE #2201460
    cógas seachlipéid Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Off-Label-Arzneimittel
    de
    Sainmhíniú zulassungsüberschreitend verwendetes Arzneimittel Tagairt "BERICHT DER KOMMISSION AN DEN RAT UND DAS EUROPÄISCHE PARLAMENT DURCHSETZUNG DES WETTBEWERBSRECHTS IM ARZNEIMITTELSEKTOR (2009-2017) Europäische Wettbewerbsbehörden arbeiten zusammen für erschwingliche und innovative Arzneimittel"
    off-label medicine
    en
    Sainmhíniú "medicinal product that is licensed for a particular set of circumstances but is used for another" Tagairt "COM-Terminology Coordination, based on: 'Ashford & St Peter’s hospitals NHS trust - Off- label medicines policy (17.12.2019)';"
    Nóta "See also off-label prescribing (related)."
    médicament non approuvé
    fr
  3. SOCIAL QUESTIONS|health|medical science · AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health

    #615604

    IATE #927305
    úsáid seachlipéid Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Thairis sin, tá rialacha sa Treoir sin maidir le doiciméadú na húsáide, athainmniú (“úsáid seachlipéid”), ordú agus dáileadh na dtáirgí íocshláinte tréidliachta a bheartaítear a úsáid i mbia-ainmhithe.' Tagairt "Rialachán (CE) Uimh. 470/2009 lena leagtar síos nósanna imeachta Comhphobail chun teorainneacha na n-iarmhar a bhunú do shubstaintí atá gníomhach ó thaobh na cógaseolaíochta de i mbia-ábhair de thionscnamh ainmhíoch, agus lena n-aisghairtear Rialachán (CEE) Uimh. 2377/90 agus lena leasaítear Treoir 2001/82/CE agus Rialachán (CE) Uimh. 726/2004, CELEX:32009R0470/GA"
    Anwendung außerhalb des zugelassenen Indikationsbereichs | zulassungsüberschreitende Anwendung | individuelle Umwidmung | nicht vorschriftsmäßige Verwendung | Off-Label-Gebrauch
    de
    Sainmhíniú Verordnung eines zugelassenen Fertigarzneimittels außerhalb des in der Zulassung beantragten und von den nationalen oder europäischen Zulassungsbehörden genehmigten Gebrauchs hinsichtlich der Anwendungsgebiete (Indikationen) und -arten Tagairt "Wikipedia https://de.wikipedia.org/wiki/Off-Label-Use (25.9.2015)"
    Nóta "XREF: Mitleidsindikation IATE:1687028"
    off-label use
    en
    Sainmhíniú "use of an approved/licensed medicinal product or veterinary medicinal product in a manner different from that approved/licensed" Tagairt "COM-Terminology Coordination, based on:Stafford, R. S., 'Regulating Off-Label Drug Use — Rethinking the Role of the FDA' (24.6.2020), New England Journal of Medicine, 2008, 358, pp. 1427-1429"
    Nóta "e.g. for different clinical indications, different populations or age groups, in different dosages, or using different forms of administration from those for which the product is approved/licensed. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways.Not to be confused with: off-label prescribing"
    utilisation hors RCP
    fr
    Sainmhíniú "usage d'un médicament vétérinaire d'une manière qui n'est pas conforme au résumé des caractéristiques du produit (""RCP""), notamment le mauvais usage ou l'abus grave du médicament" Tagairt "Directive 2001/82/CE instituant un code communautaire relatif aux médicaments vétérinaires, CELEX:32001L0082/FR , article 1er, point 16"
    Nóta "Voir aussi:- IATE:858332 résumé des caractéristiques du produit (RCP)"