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【第四十八批】仿制药参比制剂目录


【第四十八批】仿制药参比制剂目录


序号药品通用名称英文名称商品名规格持证商备注1备注2
48-1盐酸曲唑酮缓释片Trazodone Hydrochloride Sustained-release TabletsTrittico75mgAZ. Chim.Riun.Angelini Francesco Acraf S.P.A.国内上市的原研药品原研进口
48-2托吡酯胶囊Topiramate Capsules妥泰15mgJanssen-Cilag AG国内上市的原研药品原研进口
48-3托吡酯胶囊Topiramate Capsules妥泰25mgJanssen-Cilag AG国内上市的原研药品原研进口
48-4硝酸咪康唑乳膏/栓(组合包装)Miconazole Nitrate Cream and SuppositoriesMonistat 3 Combination Pack2%,200mgMedtech Products Inc未进口原研药品美国橙皮书
48-5溴吡斯的明糖浆/口服溶液Pyridostigmine Bromide Syrup(oral solution)Mestinon60mg/5mlBausch Health US LLC未进口原研药品美国橙皮书
48-6盐酸米托蒽醌注射液Mitoxantrone Hydrochloride Injection
15ml:30mgHospira Worldwide, Inc国际公认的同种药品美国橙皮书
48-7盐酸米托蒽醌注射液Mitoxantrone Hydrochloride Injection
10ml:20mgHospira Worldwide, Inc国际公认的同种药品美国橙皮书
48-8盐酸米托蒽醌注射液Mitoxantrone Hydrochloride Injection
12.5ml:25mgHospira Worldwide, Inc国际公认的同种药品美国橙皮书
48-9丁酸氢化可的松乳膏Hydrocortisone Butyrate CreamLocoid0.10%Leo Pharma A/S / Cheplapharm Arzneimittel Gmbh未进口原研药品欧盟上市
48-10利丙双卡因贴片Lidocaine and Prilocaine Patch Emla Pflaster每片含有1g乳液(利多卡因25mg,丙胺卡因25mg)Aspen Pharma Trading Limited未进口原研药品欧盟上市
48-11盐酸甲氧氯普胺注射液Metoclopramide Hydrochloride Injection
10mg/2mlSanofi-Aventis France未进口原研药品欧盟上市
48-12甲苯磺酸妥舒沙星滴眼液Tosufloxacin Tosilate ophthalmic solutionOzex0.30%富士フイルム富山化学工業株式会社未进口原研药品日本上市
48-13富马酸酮替芬鼻喷雾剂Ketotifen Fumarate Nasal Spray Zaditen0.05%サンファーマ株式会社未进口原研药品日本上市
48-14依替唑仑片Etizolam TabletsDepas0.25mgMitsubishi Tanabe Pharma Corporation未进口原研药品日本上市
48-15依替唑仑片Etizolam TabletsDepas0.5mgMitsubishi Tanabe Pharma Corporation未进口原研药品日本上市
48-16依替唑仑片Etizolam TabletsDepas1mgMitsubishi Tanabe Pharma Corporation未进口原研药品日本上市
48-17阿帕他胺片Apalutamide TabletsErleada(安森珂)60mgJanssen-Cilag International NV国内上市的原研药品原研进口
48-18碘普罗胺注射液Iopromide Injection Ultravist(优维显)100ml:62.34gBayer Vital GmbH国内上市的原研药品原研进口
48-19注射用阿糖胞苷Cytarabine for InjectionCytosar(赛德萨)0.1g辉瑞制药(无锡)有限公司经审核确定的国外原研企业在中国境内生产的药品原研地产化
48-20注射用阿糖胞苷Cytarabine for InjectionCytosar(赛德萨)0.5g辉瑞制药(无锡)有限公司经审核确定的国外原研企业在中国境内生产的药品原研地产化
48-21注射用培美曲塞二钠Pemetrexed Disodium for InjectionAlimta100mg(以培美曲塞计)Eli Lilly and Company未进口原研药品美国橙皮书
48-22注射用培美曲塞二钠Pemetrexed Disodium for InjectionAlimta500mg(以培美曲塞计)Eli Lilly and Company未进口原研药品美国橙皮书
48-23依维莫司片Everolimus TabletsAfinitor2.5mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
48-24依维莫司片Everolimus TabletsAfinitor5mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
48-25依维莫司片Everolimus TabletsZortress0.25mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
48-26依维莫司片Everolimus TabletsZortress0.5mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
48-27依维莫司片Everolimus TabletsZortress0.75mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
48-28依维莫司片Everolimus TabletsZortress1mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
48-29棕榈帕利哌酮酯注射液(3M)Paliperidone Palmitate Extended-release Injectable SuspensionInvega Trinza按棕榈帕利哌酮酯计273mg/0.875mlJanssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书
48-30棕榈帕利哌酮酯注射液(3M)Paliperidone Palmitate Extended-release Injectable Suspension Invega Trinza按棕榈帕利哌酮酯计410mg/1.315mlJanssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书
48-31棕榈帕利哌酮酯注射液(3M)Paliperidone Palmitate Extended-release Injectable Suspension Invega Trinza按棕榈帕利哌酮酯计546mg/1.75mlJanssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书
48-32棕榈帕利哌酮酯注射液(3M)Paliperidone Palmitate Extended-release Injectable Suspension Invega Trinza按棕榈帕利哌酮酯计819mg/2.625mlJanssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书
48-33缬沙坦氢氯噻嗪片Valsartan and Hydrochlorothiazide TabletsDiovan Hct每片含缬沙坦160mg,氢氯噻嗪12.5mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
48-34缬沙坦氢氯噻嗪片Valsartan and Hydrochlorothiazide TabletsDiovan Hct每片含缬沙坦160mg,氢氯噻嗪25mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
48-35醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets
2.5mgPharmacia and Upjohn Co.未进口原研药品美国橙皮书
48-36醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets
5mgPharmacia and Upjohn Co.未进口原研药品美国橙皮书
48-37醋酸钙片Calcium Acetate Tablets
0.667gChartwell Molecular Holdings Llc国际公认的同种药物美国橙皮书
48-38维生素K1注射液Vitamin K1 Injection
0.5ml:1mgHospira Inc国际公认的同种药品美国橙皮书
48-39来曲唑片Letrozole TabletsFemara2.5mgNovartis Pharma S.A.S.未进口原研药品欧盟上市
48-40棕榈酸帕利哌酮注射液Xeplion 25 mg Prolonged Release Suspension For Injection
以帕利哌酮计:25mgJanssen-Cilag International N.V.未进口原研药品欧盟上市
48-41棕榈酸帕利哌酮注射液Xeplion 50 mg Prolonged Release Suspension For Injection
以帕利哌酮计:50mgJanssen-Cilag International N.V.未进口原研药品欧盟上市
48-42棕榈酸帕利哌酮注射液Xeplion 75 mg Prolonged Release Suspension For Injection
以帕利哌酮计:75mgJanssen-Cilag International N.V.未进口原研药品欧盟上市
48-43棕榈酸帕利哌酮注射液Xeplion 100 mg Prolonged Release Suspension For Injection
以帕利哌酮计:100mgJanssen-Cilag International N.V.未进口原研药品欧盟上市
48-44棕榈酸帕利哌酮注射液Xeplion 150 mg Prolonged Release Suspension For Injection
以帕利哌酮计:150mgJanssen-Cilag International N.V.未进口原研药品欧盟上市
48-45棕榈帕利哌酮酯注射液(3M)Trevicta 175 mg Prolonged Release Suspension For Injection
按帕利哌酮计175mgJanssen-Cilag International NV未进口原研药品欧盟上市
48-46棕榈帕利哌酮酯注射液(3M)Trevicta 263 mg Prolonged Release Suspension For Injection
按帕利哌酮计263mgJanssen-Cilag International NV未进口原研药品欧盟上市
48-47棕榈帕利哌酮酯注射液(3M)Trevicta 350 mg Prolonged Release Suspension For Injection
按帕利哌酮计350mgJanssen-Cilag International NV未进口原研药品欧盟上市
48-48棕榈帕利哌酮酯注射液(3M)Trevicta 525 mg Prolonged Release Suspension For Injection
按帕利哌酮计525mgJanssen-Cilag International NV未进口原研药品欧盟上市
48-49美沙拉秦肠溶缓释颗粒Mesalazine Gastro-Resistant Prolonged-Release Granules Salofalk1gDr. Falk Pharma GmbH未进口原研药品欧盟上市
48-50美沙拉秦肠溶缓释颗粒Mesalazine Gastro-Resistant Prolonged-Release Granules  Salofalk3gDr. Falk Pharma GmbH未进口原研药品欧盟上市
48-51昂丹司琼口溶膜Ondansetron Oral Soluble Film
4mgNorgine Pharmaceuticals Limited未进口原研药品欧盟上市
48-52昂丹司琼口溶膜Ondansetron Oral Soluble Film
8mgNorgine Pharmaceuticals Limited未进口原研药品欧盟上市
48-53酮康唑乳膏Ketoconazole CreamNizoral 2% Creme2%Johnson & Johnson GmbH未进口原研药品欧盟上市
48-54盐酸罗匹尼罗片Ropinirole Hydrochloride TabletsRequip0.25mgグラクソ・スミスクライン株式会社未进口原研药品日本上市
48-55拉考沙胺注射液Lacosamide InjectionVimpat10ml:100mgユーシービージャパン株式会社未进口原研药品日本上市
48-56拉考沙胺注射液Lacosamide InjectionVimpat20ml:200mgユーシービージャパン株式会社未进口原研药品日本上市
48-57环丝氨酸胶囊Cycloserine Capsules
250mgMeiji Seikaファルマ株式会社国际公认同品种药物日本上市
8-71己酮可可碱缓释片Pentoxifylline  Modified Release TabletsTrental400mgAventis Pharma Limited/Sanofi欧盟上市不限定上市国及产地,增加持证商Sanofi
23-8氨咖待因片Acetaminophen, Caffeine and Codeine Phosphate Tablets
每片含对乙酰氨基酚300mg,咖啡因15mg,磷酸可待因8mgTeva Canada Limited未进口原研药品不限定商品名
26-133注射用达托霉素Daptomycin for injectionCubicin /Cubicin RF500mg/VialCubist Pharmaceuticals, LLC/Merck & Co., Inc.未进口原研药品增加商品名Cubicin RF
8-41地氯雷他定片Desloratadine TabletsAERIUS5mgMerck Sharp & Dohme B.V.原研进口持证商更新为Merck Sharp & Dohme B.V.
17-26铝碳酸镁咀嚼片Hydrotalcite Chewable Tablets达喜0.5g拜耳医药保健有限公司原研地产化品种药品通用名称及英文名称分别更新为铝碳酸镁咀嚼片及Hydrotalcite Chewable Tablets
31-2茚达特罗格隆溴铵吸入粉雾剂Indacaterol Maleate and Glycopyrronium Bromide Powder for InhalationUltibro每粒含马来酸茚达特罗110μg(以C24H28N2O3计)和格隆溴铵50μg(以C19H28NO3计)Novartis Pharma Schweiz AG国内上市的原研药品药品通用名称、英文名称及规格分别更新为茚达特罗格隆溴铵吸入粉雾剂、Indacaterol Maleate and Glycopyrronium Bromide Powder for Inhalation及每粒含马来酸茚达特罗110μg(以C24H28N2O3计)和格隆溴铵50μg(以C19H28NO3计)


1、参比制剂选择原则:有原研进口的应选择原研进口药作为参比制剂首选。
2、本网站所有仿制药参比制剂目录数据源自国家药品监督管理局官方网站,如有纰漏请以国家官网为准。


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