Análisis de la evolución en el acceso a los medicamentos huérfanos en España

Author:

Mestre-Ferrándiz Jorge,Iniesta Margarita,Trapero-Bertran Marta,Espín Jaime,Brosa Max

Publisher

Elsevier BV

Subject

Public Health, Environmental and Occupational Health

Reference41 articles.

1. Official Journal of the European Communities. Reglamento (CE) n.° 141/2000 del Parlamento Europeo y del Consejo, de 16 de diciembre de 1999, sobre medicamentos huérfanos. OJEC 22.1.2000. (Consultado el 28/10/2018.) Disponible en: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:018:0001:0005:en:PDF

2. US Food and Drug Administration. Orphan Drug Act: Congresssional findings for the Orphan Drug Act. Amended. En: Federal Food, Drug, and Cosmetic Act (FD&C Act). 2013. Food & Drug Administration (FDA), MD, USA.

3. Incremental cost per quality-adjusted life year gained?The need for alternative methods to evaluate medical interventions for ultra-rare disorders;Schlander;J Comp Eff Res.,2014

4. NICE Citizens Council. NICE Citizens Council Report: Ultra orphan drugs. NICE 2004. (Consultado el 28/10/2018.) Disponible en: https://www.nice.org.uk/Media/Default/Get-involved/Citizens-Council/Reports/CCReport04UltraOrphanDrugs.pdf

5. European Medicines Agency (EMA). Human regulatory; Research and Development: Orphan incentives. Londres: EMA. (Consultado el 8/12/2018.) Disponible en: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000393.jsp&mid=WC0b01ac058061f017

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