国家食品药品监督管理总局关于发布第二批过度重复药品提示信息的公告.doc

1、? 【颁布日期】2017-05-31【实施日期】2017-05-31【有效性】现行有效【全文】国家食品药品监督管理总局关于发布第二批过度重复药品提示信息的公告国家食品药品监督管理总局公告2017第70号为客观反映我国药品市场的供需动态，科学引导药品研发机构和企业有序研发和理性申报，避免低水平重复和资源浪费，按照国务院关于改革药品医疗器械审评审批制度的意见（国发201544号）和国家食品药品监督管理总局关于药品注册审评审批若干政策的公告（2015年第230号）要求，国家食品药品监督管理总局委托中国药学会，对已获批上市药品在20132015年间的销售情况进行监测分析，按照符合已获批准文号企业数20

2、家、且样本医院（CMEI）监测3年在销批准文号企业数20家的条件，或符合已获批准文号企业数20家、且样本药店（RDM）监测3年在销批准文号企业数20家的条件进行通用名品种筛选，共遴选出294个品种，涉及临床药理学和治疗学分类的13个大类、59个亚类，现予以公告。与2016年第153号公告发布的药品目录相比，新增13个品种，有1个品种从原目录中调出。国家食品药品监督管理总局提醒相关药品生产企业和研发机构，要充分了解市场供需状况，科学评估药品研发风险，慎重进行投资经营决策。各省、自治区、直辖市食品药品监督管理部门要加强对相关药品注册申请的受理审查、研制现场核查和生产现场检查，对已经公布的过度重复药

3、品品种，主动做好宣传工作，引导企业理性研发和申报。特此公告。附件：同一药品已获批准文号企业数在20家以上的过度重复品种目录国家食品药品监督管理总局二一七年五月三十一日附件：同一药品已获批准文号企业数在20家以上的过度重复品种目录序号通用名已经批准文号数量已经批准文号企业数量CMEI监测三年批文数CMEI监测三年企业数CMEI监测批文CR10销售金额占比CMEI监测批文CR10使用量占比RDM零售监测3年在销批文数RDM零售监测3年在销批文企业数RDM零售监测批文CR10销售金额占比RDM零售监测批文CR10使用量占比1甲硝唑108876427320569.6924.7417614988.187

4、8.992葡萄糖165333782718335.8332.22000.000.003维生素C178078429117845.936.941209290.4470.244利巴韦林69742722917575.6033.8815113180.4981.345左氧氟沙星66529630917476.8737.3532319547.7851.536氯化钠85825454317244.8037.9832100.00100.007阿奇霉素58428629516289.6671.4331520263.8556.898维生素B676152018214243.8016.72686081.5577.799诺氟沙星

5、81471314213357.9462.6021220253.2752.5910维生素B186156216113160.3858.78575578.8179.4311碳酸氢钠35222614111782.2134.91332899.3199.3612阿昔洛韦25719314111661.9219.2613610358.8276.6713克林霉素47525523411446.5335.451289277.6057.9814庆大霉素69234316310853.6846.70987458.9657.2115氟康唑25620013710794.9767.201048664.9462.8716肌苷77

6、252713010487.6645.03666287.9691.3317甘露醇24216211610278.9572.57000.000.0018对乙酰氨基酚100558112210187.5849.8714012186.4677.1719雷尼替丁51145011110165.7655.52908877.2675.7720葡萄糖氯化钠85021031610147.5742.92000.000.0021复方对乙酰氨基酚720568999297.5784.2918817368.4055.0122二甲双胍1821491128888.1758.111109180.7068.8923氧氟沙星383281

7、1138790.4069.561419971.2281.6924替硝唑2181671098569.8227.15998459.4875.3725西咪替丁6124441098584.4422.57615088.4771.9226复方氨酚那敏438350918496.9573.1824918669.7767.4927环丙沙星3642651038298.2566.21958170.3277.6828维生素B2499341978291.899.86464686.7888.4529奥美拉唑钠1311001058282.0765.85232299.0399.6530罗红霉素245153948198.489

8、3.3319814170.4963.9531维生素B124811911108176.5544.39222299.4599.9432复方氨酚烷胺250212837782.0766.1822018971.4167.1233氨溴索167921227785.1779.271046481.7981.2934泮托拉唑钠148891227766.9249.15403385.9184.7035复方氯化钠183144807773.8271.60127100.0099.9936头孢氨苄5812821107693.7479.4814311265.8857.7437奥美拉唑132109877690.1971.0810

9、19067.8360.8438克拉霉素1811261067693.0072.961218969.8762.4139布洛芬515358967688.8466.041258876.3774.1340氯苯那敏386325847675.7073.47525182.2487.9241复方磺胺甲?唑1184894767576.7276.83565694.5882.3242谷维素245238767571.6365.54000.000.0043硝苯地平302224877498.8780.86605392.7468.1444葡萄糖酸钙235174827483.0954.14555298.4993.9845卡托普

10、利297231787496.8579.32474485.0875.2846注射用水521226977482.1340.62000.000.0047单硝酸异山梨酯145951087384.0185.03503894.2292.8748头孢拉定4312301067192.8583.3117312879.8182.5049氯霉素765565787092.5466.75696195.7784.5450小檗碱860568727081.6683.08545390.8090.8951阿司匹林526310867099.0188.6511899.9999.8952阿莫西林4061561236787.3067.1

11、220211775.8467.9953阿米卡星197130756779.2466.44161398.3498.4354地塞米松磷酸钠278138896787.4982.4244100.00100.0055双氯芬酸钠298264776584.9369.3213211079.2171.3856利福平676508706496.1274.23423994.6397.2057复方氨林巴比妥140140646476.2773.82000.000.0058去痛片521510636379.9070.66555388.9596.7059氨茶碱320216766370.2723.10282594.0095.946

12、0红霉素779519836294.3788.20936668.3767.6461更昔洛韦203117956278.9675.95241695.3095.4262辛伐他汀15689956187.5779.39866279.0266.5463吡拉西坦590426776199.2366.13000.000.0064异烟肼557362676088.2980.14342887.4188.9265克霉唑171124725994.9664.25726090.3771.7466氨氯地平8775635897.9494.66646191.8589.2967氯雷他定6861655790.7480.86635578.

13、0273.8468奥扎格雷钠157781035767.5355.57372887.4089.5369胞磷胆碱钠200117735798.3197.32000.000.0070尼莫地平152107785688.6148.92332894.0688.9871氯化钾12099675688.6770.32000.000.0072利多卡因18195915677.5851.56000.000.0073阿莫西林克拉维酸钾132611065573.8662.48534072.4474.8574格列齐特10595625498.7494.39706492.5882.7675头孢曲松钠25383895398.217

14、6.84564487.4491.3276头孢哌酮钠舒巴坦钠321811575394.0974.42594479.2984.6177曲克芦丁456339685371.9360.45433597.4898.2278呋塞米10797605383.8486.18121299.9699.9979乙酰谷酰胺10066665377.1756.27000.000.0080尼群地平172169525284.0862.67272792.3995.4381头孢他啶278801125294.1785.05282799.4199.4082阿托品258126805294.5475.7311100.00100.0083头孢

15、克洛11772805084.4673.59956680.5676.1184法莫替丁107123535095.0391.48323298.5097.5785复方甘草5850584977.8761.31796050.2062.2786复合维生素B125115494975.2370.65292885.0286.0187头孢米诺钠15660954977.1561.89109100.00100.0088右旋糖酐40271116744997.2883.50000.000.0089林可霉素595369514892.1376.19343284.7184.2090头孢呋辛钠302781514884.1766.9

16、2413198.5599.7091三磷酸腺苷二钠160120574865.8453.72000.000.0092复方氨基酸（18AA）189721364870.3551.27000.000.0093复方乳酸钠林格6956514891.6574.39000.000.0094头孢克肟11157874781.8469.031036066.0563.5895二乙酰氨乙酸乙二胺11880594775.8269.59000.000.0096吲哚美辛293236524699.3170.60464299.1990.8697格拉司琼8271514583.5968.55000.000.0098甲氧氯普胺11097

17、484493.1176.13202096.0098.8299复方甘油6551524481.9480.64000.000.00100格列吡嗪9281464397.6988.67525195.1590.11101兰索拉唑6853494395.3376.01302787.0186.71102咪康唑8877514297.1591.55976492.5892.74103葛根素187118644282.0273.51494481.5091.59104地塞米松148134444296.3296.0355100.00100.00105泼尼松190184424292.6691.56000.000.00106替米

18、沙坦7655574192.4981.29554782.8177.41107加替沙星11663524092.3674.12644671.6885.07108氟桂利嗪6262414098.6290.62414198.0293.50109紫杉醇6038604087.0671.08000.000.00110复方地塞米松10597433990.8676.04926691.1188.50111硝酸异山梨酯11894513994.4734.33272393.2995.95112维生素E19691623893.1373.24533881.3575.69113甲钴胺5741543890.9290.7821199

19、6.5696.48114山莨菪碱14885473891.1956.95231899.1499.94115倍他司汀8570433898.7893.35161699.98100.00116复方曲安奈德9388403790.2469.25694978.4794.99117吗啉胍295272363679.4774.80504980.5078.49118川芎嗪148115423698.6973.47433885.7799.41119妥布霉素9480423698.1686.13393298.8496.71120安乃近1215763423695.9295.35343196.4594.91121沙丁胺醇103

20、81473695.7327.39322798.0697.47122葡醛内酯209149483694.9884.52241895.9897.23123头孢西丁钠10151643678.6082.8355100.00100.00124环磷腺苷6748463673.4770.61000.000.00125聚维酮碘15474563583.1463.42734792.3376.75126喷托维林215205353594.9189.30373684.5895.70127甘草酸二铵8067413599.3899.6174100.00100.00128胸腺五肽6353453492.3878.51000.000

21、.00129非那雄胺4840373398.9796.93363695.7591.76130吲达帕胺4742373396.6285.64383594.1793.43131头孢噻肟钠20773633392.5984.72242299.2698.16132苦参碱143126373389.0860.27222193.4395.30133氢化可的松186102453396.1666.1822100.00100.00134硫普罗宁钠6652483380.5066.3032100.00100.00135双嘧达莫211204333392.3091.01000.000.00136卡马西平143114353399

22、.0994.52000.000.00137酚磺乙胺10662453388.0285.38000.000.00138阿魏酸钠13283543271.5939.29171695.4899.51139亚叶酸钙9551563290.1163.14000.000.00140硫糖铝9180343199.1975.24262691.9190.73141异丙嗪12887403194.9882.00161399.9899.96142复方甘草酸单铵7661413182.3273.28121099.8499.38143氢氯噻嗪9070333198.5097.2598100.00100.00144氯丙嗪1691053

23、93191.3089.04000.000.00145木糖醇11459433192.9892.55000.000.00146长春西汀5934563194.6989.34000.000.00147牛磺酸175143333091.5379.53564867.9983.64148特拉唑嗪4536333097.0790.11272797.9796.48149萘普生512299303097.3192.99212197.7998.58150左卡尼汀4634413088.2075.6544100.00100.00151氨甲环酸9544543090.5654.31000.000.00152果糖二磷酸钠80396

24、13075.3385.55000.000.00153西替利嗪4743312995.3586.84423989.9592.22154特比萘芬7249382995.5997.91813865.1166.14155吡嗪酰胺9978302997.4997.38161599.7099.66156头孢唑林钠13170522998.9384.49141299.5799.85157多索茶碱5938412972.6046.4011899.98100.00158复方氨基酸（15AA）7744332998.4086.1811100.00100.00159门冬氨酸钾镁8464372999.1389.29000.000

25、.00160羟乙基淀粉8145552987.4778.65000.000.00161环磷腺苷葡胺6342502965.8265.78000.000.00162洛美沙星173119362895.1280.17704572.3074.98163尼美舒利4535362889.2984.67483584.2981.91164复方阿司匹林292288292897.6897.11252296.2899.76165天麻素9464452893.7079.75211790.1397.23166美托洛尔7842432899.2299.04201399.9099.91167氨曲南5324592856.2558.86

26、161094.9695.06168甲硫氨酸维B19956492885.6373.40000.000.00169胶体果胶铋6048352795.4886.49383173.4173.48170多潘立酮3129292798.9398.01272697.5096.88171苦参素13398322790.2891.67121199.98100.00172溴己新5352272799.5546.8788100.00100.00173昂丹司琼7041452793.9793.0542100.00100.00174托烷司琼4529372778.7679.4411100.00100.00175水溶性维生素2828

27、272793.6593.4821100.00100.00176普鲁卡因185112322792.7581.55000.000.00177普罗帕酮12187322791.5375.34000.000.00178胸腺肽25674762781.6383.95000.000.00179卡络磺钠9147392785.3062.13000.000.00180三磷酸胞苷二钠5738432779.0874.10000.000.00181乙酰螺旋霉素608446272695.2294.33797586.6384.11182?丙酯8965292689.5386.7755100.00100.00183过氧化氢292

28、9262693.3693.01000.000.00184纳洛酮8724832657.5344.77000.000.00185四环素721441292593.6194.07272396.9198.93186普萘洛尔7774252598.9798.45151599.2599.39187大黄碳酸氢钠113112252599.0598.89131399.9999.91188苯海拉明6964272599.2892.791010100.00100.00189哌拉西林钠他唑巴坦钠8325662576.4557.5064100.00100.00190头孢唑肟钠7730612571.3661.8833100.0

29、0100.00191呋喃唑酮489343262498.3796.52474187.3687.76192伐昔洛韦5433342475.1673.74453081.7884.56193美洛昔康4633282494.6893.04262298.0798.09194非诺贝特9681292499.4987.64242099.7598.06195乙胺丁醇223200262496.1895.53161599.0999.05196头孢吡肟6633462479.8175.18131197.9098.61197琥乙红霉素418217302398.9395.95947799.5799.37198双唑泰4442252

30、399.4897.34444079.6977.69199右美沙芬4740252399.3498.86493278.3690.96200复方利血平7169252397.4394.01262596.1995.12201蒙脱石3532252396.8490.93302597.1397.51202羧甲司坦122112312398.9289.56272492.1391.71203多西环素10884262399.4776.77232295.5198.03204酚酞8865312394.8493.92272194.0189.16205吡格列酮3524282388.3179.38242189.5589.252

31、06头孢替唑钠9524612382.9778.9965100.00100.00207氨甲苯酸6742242397.1296.19000.000.00208丙氨酰谷氨酰胺3923382382.0282.54000.000.00209氨苄西林17379362294.9663.54443599.3998.55210酚氨咖敏240176232299.2798.25333085.5687.47211酮替芬7771242290.7888.97252385.6497.58212枸橼酸铋钾8565272297.5193.40242199.7299.56213复方氢氧化铝9191222297.6697.2116

32、1699.5599.59214熊去氧胆酸4239252299.7594.20161599.9399.26215复方甘草酸苷3319372275.4792.10171499.5899.93216复方消化酶6459232299.9598.34131399.4499.41217美洛西林钠8722652280.2981.8087100.00100.00218高乌甲素5743292292.2974.95000.000.00219铝碳酸镁4238242198.7697.45312999.0098.38220依那普利2920322194.0288.85261797.0196.90221茶碱4942222195.9494.041515