Stosowanie produktów leczniczych "off -label use" w populacji pediatrycznej- dzia? anie na granicy ryzyka, czy do? ozenie nalezytej staranno? ci?
Przegla?d lekarski 2011; 68(1): 33-9
Any medicinal product marketed in the country has its registration, under which are strictly defined indications and the extent to which a product can be used. It is of significance that the use of the product which is registered in the given range produces an effect similar to or identical to that effect, which is obtained after applying the product having a registration in a given indication. Relied on to justify the use of a medicinal product or medical product "off-label use" in Poland, there is also the fact that the same product has a registration in a particular indication in another EU member state or outside the Community. It is worth noting that the medicinal product may be used in therapeutic management of omitting or reducing the principles resulting from the SPC. However, this applies only to cases where the use of the medicinal product "off-label use" dictated by the necessity of saving life or health of the patient, and the previous ways and methods of treatment with the use of registered medicines have proved ineffective or insufficient to achieve the desired therapeutic effect.
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Avis n° 47 du 9 mars 2009 relatif aux implications éthiques de la législation concernant les programmes d'usage compassionnel (compassionate use) et les programmes médicaux d'urgence (medical need) L'usage «off label» ou usage hors des indications reconnues. Demande d'avis en date du 27 juin 2007, de Monsieur Marc Bogaert, Président du comité d'éthique médicale de l'AZ Sint-Lucas à Gand. Opinion no. 47 of 9 March 2009 on the ethical implications of legislation on compassionate use and medical need programs. Unregistered and off-label usage Unknown author (Comité Consultatif de Bioéthique (Belgique) = Belgian Advisory Committee on Bioethics, 2009-03)