Gaois

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

    #583885

    IATE #3549999
    oideasú seachlipéid Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Verschreibung außerhalb der Zulassung
    de
    off-label prescribing
    en
    Definition prescription of a medication in a manner different from that approved Reference 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]
    Comment 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
    Definition 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 Reference 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
    Comment RCP pour résumé des caractéristiques du produit