R. Aparicio Hernández, et al. ment_library/Summary_of_opinion_-_Initial_authorisation/human/002611/ WC500194119.pdf 45. European Medicines Agency Assesment report: Okrambi. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_ assessment_report/human/003954/WC500197613.pdf 46. Wainwright CE, Elborn JS, Ramsey BW, Marigowda G, Huang X, Cipolli M et al. N Engl J Med. 2015 Jul 16;373(3):220-31. Lumacaftor–Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR. Disponible en: http://www.nejm.org/doi/full/10.1056/NEJMoa1409547 47. European Medicines Agency. Committe for Medical Products for Humans (CHMP). Disponible en: http://www.ema.europa.eu/docs/en_GB/docu-ment_ library/Summary_of_opinion_-_Initial_authorisation/human/003954/ WC500194120.pdf 48. European Medicines Agency. Committe for Medical Products for Humans (CHMP).Disponible en: http://www.ema.europa.eu/docs/en_GB/docu-ment_ library/Summary_of_opinion_-_Initial_authorisation/human/003860/ WC500194118.pdf 49. Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18; 380:651-9. Disponible en : http://www.thelancet.com/journals/lancet/article/PIIS0140- 6736(12)60988-X/abstract 50. Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25; 371(13):1198-207. Disponible en: http://www.nejm. org/doi/full/10.1056/NEJMoa1403290 51. Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1189-97.Disponible en: http://www.nejm. org/doi/full/10.1056/NEJMoa1403291 52. European Medicines Agency Assesment report: Nucala. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_ assessment_report/human/003860/WC500198038.pdf 53. EMA. CHMP. Disponible en: http://www.ema.europa.eu/ema/index. jsp?curl=pages/medicines/human/medicines/003789/smops/Positive/human_ smop_000910.jsp&mid=WC0b01ac058001d127 54. FDA. Approval for pegaspargase. Disponible en: http://www.fda.gov/about-fda/ centersoffices/officeofmedicalproductsandtobacco/cder/ucm095609.htm 55. Dinndorf PA, Gootenberg J, Cohen MH, Keegan P and Pazdur R. FDA drug approval summary: pegaspargase (oncaspar) for the first-line treatment of children with acute lymphoblastic leukemia (ALL). Oncologist. 2007 Aug;12(8):991-8. Disponible en: http://theoncologist.alphamedpress.org/con-tent/ 12/8/991.long 56. Avramis VI, Sencer S, Periclou AP, Sather H, Bostrom BC, Cohen LJ et al. A randomized comparison of native Escherichia coli asparaginase and 52 Sanid. mil. 2016; 72 (1) polyethylene glycol conjugated asparaginase for treatment of children with newly diagnosed standard-risk acute lymphoblastic leukemia: A Children’s Cancer Group study. Blood 2002;99:1986-1994. Disponible en: http://www. bloodjournal.org/content/99/6/1986.full 57. EMA. CHMP. Wakix® .Disponible en: http://www.ema.europa.eu/docs/ en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/hu-man/ 002616/WC500196742.pdf 58. Van der Heide A, van Schie MK, Lammers GJ, Dauvilliers Y, Arnulf I, Ma-yer G et al. Comparing Treatment Effect Measurements in Narcolepsy: The Sustained Attention to Response Task, Epworth Sleepiness Scale and Main-tenance of Wakefulness Test. Sleep. 2015 Jul 1;38(7):1051-8. Disponible en: http://www.journalsleep.org/ViewAbstract.aspx?pid=30072 59. Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A et al.(HARMONY I study group). Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol. 2013 Nov;12(11):1068-75. Disponible en: http://www.thelancet.com/journals/ laneur/article/PIIS1474-4422(13)70225-4/abstract 60. Kasteleijn-Nolst Trenité D, Parain D, Genton P, Masnou P, Schwartz JC, Hirsch E et al. Efficacy of the histamine 3 receptor (H3R) antagonist pi-tolisant (formerly known as tiprolisant; BF2.649) in epilepsy: dose-depen-dent effects in the human photosensitivity model. Epilepsy Behav. 2013 Jul;28(1):66-70. Disponible en: http://www.epilepsybehavior.com/article/ S1525-5050(13)00157-1/abstract 61. Lin JS, Dauvilliers Y, Arnulf I, Bastuji H, Anaclet C, Parmentier R et al. An inverse agonist of the histamine H(3) receptor improves wakeful-ness in narcolepsy: studies in orexin-/- mice and patients. Neurobiol Dis. 2008 Apr;30(1):74-83. Disponible en: http://www.ncbi.nlm.nih.gov/pub-med/ 18295497 62. EMA. Committe for Medical Products for Humans (CHMP). Disponible en: http://www.ema.europa.eu/docs/es_ES/document_library/EPAR_-_Pro-duct_ Information/human/004062/WC500197536.pdf 63. McMurray J, Packer M, Desai A, Gong J, Lefkowitz M, Rizkala A, et al. Angiotensin-neprilysins inhibition versus enalapril in heart failure. N Engl J Med 2014; 371: 993-1004. 64. Packer M, McMurray J, Akshay S, Desai A, Gong J, Lefkowitz M, et al. An-giotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Circulation 2015; 131: 54-61. 65. Agencia Española de Medicamentos y Productos Sanitarios. Informe men-sual sobre Medicamentos de Uso Humano y Productos Sanitarios octu-bre 2015. Disponible en: http://www.aemps.gob.es/informa/boletinMen-sual/ 2015/octubre/boletin-octubre.htm#nuevosMed 66. Andtbacka RH, Kaufman HL, Collichio F, Amatruda T, Senzer N, Chesney J, et al. Talimogene Laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015; 33: 2780-8.
REVISTA DE SANIDAD FAS ENE MAR 2016
To see the actual publication please follow the link above