21. К запросу прилагаются материалы

21. К запросу прилагаются материалы-обоснования доказанной клинической эффективности, безопасности лекарственного препарата:
1) мета-анализы, систематические обзоры медицинской литературы и рандомизированные клинические испытания;
2) сравнительные анализы рассматриваемого лекарственного средства для включения в формуляр, с другими лекарствами из формулярного перечня, использующимися по тем же показаниям;
3) результаты фармакоэкономических исследований для экономической обоснованности включения в формуляр, а также в сравнении с другими лекарствами из формулярного перечня, использующимися по тем же показаниям;
4) наличие предлагаемого лекарственного средства в клинических руководствах, протоколах (стандартов) диагностики и лечения республики и (или) в международных клинических руководствах Национального института здоровья и клинического совершенства Великобритании и в Британском национальном формуляре.

Results (English) 1:

21. the attached materials-study demonstrated clinical efficacy and safety of the medicinal product: 1) meta-analyses, systematic reviews of the medical literature and randomized clinical trials; 2) comparative analyses of the medicinal product for inclusion in form with other medications of the meantime for the form list used for similar reasons; 3) results farmakoèkonomičeskih researches the economic rationale for inclusion in form as well as in comparison with other drugs of the meantime for the form list used for similar reasons; 4) have proposed a drug in clinical guidelines, protocols (standards) the diagnosis and treatment of RA and (or) in international clinical guidelines of the National Institute of health and clinical excellence in the UK and British national form.

Results (English) 2:

21. To request attached materials-justification proven clinical efficacy, safety, drug:
1) meta-analyzes, systematic reviews of the medical literature and randomized clinical trials,
2) comparative analysis considers the drug to be included in the form, with other medicines from the formulary list Use for the same reasons;
3) the results of pharmacoeconomic studies for inclusion in the economic feasibility of the form, as well as in comparison with other drugs of the formulary list is used for the same indications;
4) the availability of the proposed drug in clinical guidelines, protocols (standards) diagnostics and treatment of the Republic and (or) in international clinical guidelines of the National Institute for Health and Clinical Excellence in the UK and the British National Formulary.

Results (English) 3:

21. The request included materials to justify proven clinical effectiveness, safety drug:
(1) meta-analyzes,Systematic reviews medical literature and randomized clinical trials;
(2) comparative analyzes the medicinal product for inclusion in a case,The other medicines from формулярного list, are used for the same readings;
(3) the results фармакоэкономических studies for economic reasons for inclusion in a case,As well as in comparison with other medicines from формулярного list, are used for the same readings;
(4) the existence of the medicinal product in clinical manuals,Protocols (standards) diagnosis and treatment of and (or) in the international clinical manuals national institute for health and clinical excellence in Great Britain and British national