Sistema de Información Esencial en Terapéutica y Salud


Última actualización: 29/11/2020
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1.Enlace a cita originalTiene citas relacionadas Cita con resumen
Pacurariu A, Plueschke K, Olmo CA, Kurz X. Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators. Pharmacoepidemiol Drug Saf 2018;27:julio. [Ref.ID 102879]
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Garattini S, Bertele V. Benefits, benefits, once more benefits... with no risk? Stop overlooking the harms of medicines. Eur J Clin Pharmacol 2018;74:marzo. [Ref.ID 102550]
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Anónimo. FDA to evaluate increased risk of heart -related death and death from all causes with the gout medicine febuxostat (Uloric). U.S. Food and Drug Administration 2017:15 de noviembre. [Ref.ID 102144]
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Santoro A, Genov G, Spooner A, Raine J, Arlett P. Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug Saf 2017;40:855-69. [Ref.ID 102075]
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Edwards IR. A new Erice report considering the safety of medicines in the 21st Century. Drug Saf 2017;40:845-9. [Ref.ID 102074]
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Bouvy JC, Blake K, Slattery J, De Bruin ML, Arlett P, Kurz X. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005–2013. Pharmacoepidemiol Drug Saf 2017;26:26 de marzo. [Ref.ID 101903]
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Anónimo. FDA approves first drug treatment for Peyronie’s disease . U.S. Food and Drug Administration 2013:1. [Ref.ID 96567]
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Fain K, Daubresse M, Alexander GC. The Food and Drug Administration Amendments Act and postmarketing commitments. JAMA 2013;310:202-4. [Ref.ID 95794]
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Frau S, Font Pous M, Luppino MR, Conforti A. Risk management plans: are they a tool for improving drug safety?. Eur J Clin Pharmacol 2010;66:785-90. [Ref.ID 89061]
Arana A, Allen S, Burkowitz J, Fantoni V, Ghatnekar O, Rico MT, Vanhaverbeke N, Wentworth CE, Brosa M, Arellano FM. Infliximab paediatric Crohn's disease educational plan: a European, cross-sectional, multicentre evaluation. Drug Saf 2010;33:489-501. [Ref.ID 88648]
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Laporte JR. Pour une pharmacovigilance plus ambitieuse. Prescrire 2010;30:391-3. [Ref.ID 88457]
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Moore N, Bégaud B. Improving pharmacovigilance in Europe. BMJ 2010;340:821-2. [Ref.ID 88334]
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Giezen TJ, Mantel-Teeuwisse M, Straus SMJM, Egberts TCG, Balckburn S, Persson I, Leufkens HGM. Evaluation of post-authorization safety studies in the first cohort of EU risk management plans at time of regulatory approval. Drug Saf 2009;32:1175-87. [Ref.ID 87302]
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Anónimo. The licensing of medicines in the UK. Drug Ther Bull 2009;47:45-8. [Ref.ID 85724]
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Anónimo. Pharmacovigilance: un project innacceptable de la Commission européenne. Prescrire 2008;28:461-5. [Ref.ID 83108]
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Cooper AJP, Lettis S, Chapman CL, Evans SJW, Waller PC, Shakir S, Payvandi N, Murray AB. Developing tools for the safety specification in risk management plans: lessons learned from a pilot project. Pharmacoepidemiol Drug Saf 2008;17:45-454. [Ref.ID 82982]
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