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Evaluación positiva de medicamentos: septiembre, octubre y noviembre 2018 Sanid. mil. 2019; 75(1)  25 posible. En cuanto a la seguridad, aunque se notificaron eventos adversos graves no se relacionaron con la intervención si no con problemas clínicos de base. La mayoría de los eventos oculares fueron de intensidad leve, siendo los más frecuentes: hiperemia conjuntival, cataratas e incremento de la presión intraocular.Por lo que se concluyó que el reemplazo genético a través de voreti-gene neparvovec mejora la visión funcional en la distrofia reti-niana hereditaria mediada por RPE65 en pacientes previamente no tratados. Luxturna® debe ser administrado por un cirujano de retina con experiencia en cirugía macular. BIBLIOGRAFÍA 1. Agencia española de Medicamentos y Productos Sanitarios. Informe men-sual sobre medicamentos de uso humano y productos sanitarios (AEMPS). Octubre 2018. Disponible en: https://www.aemps.gob.es/informa/boletines- AEMPS/boletinMensual/2018/octubre/boletin-octubre.htm#nuevosMed 2. European Medicine Agency (EMA). European Public Assesment Report (EPAR). Flucelvax Tetra®. Disponible en: https://www.ema.europa.eu/do-cuments/ assessment-report/flucelvax-tetra-epar-public-assessment-report_ en.pdf 3. Moa AM, Chughtai AA, Muscatello DJ, Turner RM, MacIntyre CR. Immu-nogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. Vac-cine. 2016 Jul 29;34(35):4092-4102. 4. Agencia española de Medicamentos y Productos Sanitarios. Informe men-sual sobre medicamentos de uso humano y productos sanitarios (AEMPS). Noviembre 2018. Disponible en: https://www.aemps.gob.es/informa/boleti-nes- AEMPS/boletinMensual/2018/noviembre/boletin-noviembre.htm 5. EMA/CHMP/784876/2018. Erleada®. Disponible en: https://www.ema.eu-ropa. eu/documents/smop-initial/chmp-summary-positive-opinion-erleada_ en.pdf 6. Saad F, Cella D, Basch E, Hadaschik BA, Mainwaring Pn, Oudard S, et al. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol 2018; 19 (10): 1404-16. 7. Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med 2018; 378: 1408-18. 8. Agencia española de Medicamentos y Productos Sanitarios. Informe men-sual sobre medicamentos de uso humano y productos sanitarios (AEMPS). Septiembre 2018. Disponible en: https://www.aemps.gob.es/informa/boleti-nes- AEMPS/boletinMensual/2018/septiembre/boletin-septiembre.htm 9. EMA/CHMP/583486/2018. Alunbrig®. Disponible en: https://www.ema. europa.eu/documents/smop-initial/chmp-summary-positive-opinion-alun-brig_ en.pdf 10. Camidge DR, Kim HR, Ahn MJ, Yang JC, Han JY(1), Lee JS,et al. Briga-tinib versus Crizotinib in ALK-positive non small cell lung cancer. N Engl J Med 2018; 379: 2027-39. 11. Kim DW, Tiseo M, Ahn Mj, Reckamp KL, Hansen KH, Kim SW, et al. Brigatinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small cell lung cancer: a randomized, multicenter phase II trial. J Clin Oncol 2017; 35: 2490-98. 12. Gettinger SN, Bazhenova LA, Langer CJ, Salgia R, Gold KA, Rosell R, et al. Activity and safety of brigatinib in ALK-rearranged non-small-cell lung can-cer and other malignancies: a single-arm, open-label, phase 1-II trial. Lancet Oncol 2016; 17: 1683-96. 13. EMA/CHMP/637902/2018. Jivi ®. Disponible en: https://www.ema.europa. eu/documents/smop-initial/chmp-summary-positive-opinion-jivi_en.pdf 14. EMA/CHMP/619927/2018. Pifeltro®. Disponible en: https://www.ema.europa. eu/documents/smop-initial/chmp-summary-positive-opinion-pifeltro_en.pdf 15. Molina JM, Squires K, Sax PE, Cahn P, Lombaard J, DeJesus E, et al. DRI-VE- FORWARD Study Group. Doravirine versus ritonavir-boosted daruna-vir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial. Lancet HIV. 2018; 5: e211-e220. 16. EMA/CHMP/619909/2018. Delstrigo®. Disponible en: https://www.ema. europa.eu/documents/smop-initial/chmp-summary-positive-opinion-delstri-go_ en.pdf 17. Orkin C, Squires KE, Molina JM, Sax PE, Wong WW, Sussmann O, et al. DRIVE-AHEAD Study Group. Doravirine/Lamivudine/Tenofovir Disopro-xil. Fumarate is non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in treatment-naive adults with human immunodeficiency virus-1 infection: week 48 results of the DRIVE-AHEAD trial. 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Lipworth BJ, Collier DJ, Gon Y, Zhong N, Nishi K, Chen R, et al. Impro-ved lung function and patient-reported outcomes with co-suspension deli-very technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized Phase III study conducted in Asia, Europe, and the USA. Int J Chron Obstruct Pulmon Dis. 2018 Sep26;13: 2969-2984. 23. Garcia, J. M., Swerdloff, R., Wang, C., Kyle, M., Kipnes, M., Biller, B. M., et al (2013). Macimorelin (AEZS-130)-stimulated growth hormone (GH) test: validation of a novel oral stimulation test for the diagnosis of adult GH defi-ciency. The Journal of clinical endocrinology and metabolism, 98(6), 2422-9. 24. Agrawal V, Garcia JM. The macimorelin-stimulated growth hormone test for adult growth hormone deficiency diagnosis. Expert Rev Mol Diagn. 2014 Jul;14(6):647-54. 25. European Medicines Agency (EMA). Committe for Medical Products for Humans (CHMP).Vabomere®. Disponible en: https://www.ema.europa.eu/ en/medicines/human/summaries-opinion/vabomere 26. Vabomere® product information. Food and Drugs Administration (FDA). Disponible en: https://www.accessdata.fda.gov/drugsatfda_docs/ label/2017/209776lbl.pdf 27. Kaye KS, Bhowmick T, Metallidis S, Bleasdale SC, Sagan OS, Stus V, et al. Effect of Meropenem-Vaborbactam vs Piperacillin-Tazobactam on Clinical Cure or Improvement and Microbial Eradication in Complicated Urinary Tract Infection: The TANGO I Randomized Clinical Trial. JAMA. 2018 Feb27;319(8):788-799. 28. EMA/CHMP/700432/2018. Disponible en: https://www.ema.europa.eu/do-cuments/ smop-initial/chmp-summary-positive-opinion-takhzyro_en.pdf 29. Banerji A, Riedl MA, Bernstein JA, Cicardi M, Longhurst HJ, Zuraw BL et al. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomized clinical trial. JAMA. 2018; 320: 2108-21. 30. EMA/CHMP/716161/2018. 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