Gaois

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

    #615604

    IATE #927305
    úsáid seachlipéid Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '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.' Reference "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
    Definition 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 Reference "Wikipedia https://de.wikipedia.org/wiki/Off-Label-Use (25.9.2015)"
    Comment "XREF: Mitleidsindikation IATE:1687028"
    off-label use
    en
    Definition "use of an approved/licensed medicinal product or veterinary medicinal product in a manner different from that approved/licensed" Reference "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"
    Comment "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
    Definition "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" Reference "Directive 2001/82/CE instituant un code communautaire relatif aux médicaments vétérinaires, CELEX:32001L0082/FR , article 1er, point 16"
    Comment "Voir aussi:- IATE:858332 résumé des caractéristiques du produit (RCP)"