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【第三十三批】仿制药参比制剂目录


【第三十三批】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
33-1盐酸尼卡地平注射液Nicardipine Hydrochloride InjectionPerdipine(佩尔)10ml:10mgAstellas Pharma Inc./ LTL Pharma Co., Ltd.国内上市的原研药品原研进口
33-2柑橘黄酮片Citrus Bioflavonoids TabletsAlvenor(爱脉朗)500mg(以总黄酮计)Les Laboratoires Servier国内上市的原研药品原研进口
33-3柑橘黄酮片Citrus Bioflavonoids TabletsDaflon500mg(以总黄酮计)Les Laboratoires Servier未进口原研药品法国上市
33-4盐酸特比萘芬乳膏Terbinafine Hydrochloride Cream-0.01GSK Consumer Healthcare Schweiz AG国内上市的原研药品原研进口
33-5氯替泼诺混悬滴眼液Loteprednol Etabonate Ophthalmic Suspension-0.2%(5ml:10mg;10ml:20mg)Bausch & Lomb Incorporated国内上市的原研药品原研进口
33-6卡铂注射液Carboplatin InjectionParaplatin(伯尔定)150mg/15mlBristol-Myers Squibb SA国内上市的原研药品原研进口
33-7卡铂注射液Carboplatin InjectionParaplatin(伯尔定)5ml:50mgBristol-Myers Squibb Co., Ltd.未进口原研药品日本上市
33-8酒石酸西尼必利片Cinitapride Hydrogen Tartrate TabletsCidine(希笛尼)1mg(按西尼必利计)Almirall, S.A.国内上市的原研药品原研进口
33-9依普利酮片Eplerenone TabletsInspra25mgGD Searle LLC未进口原研药品美国橙皮书
33-10依普利酮片Eplerenone TabletsInspra50mgGD Searle LLC未进口原研药品美国橙皮书
33-11青霉胺片Penicillamine TabletsDepen250mgMylan Speciality Lp未进口原研药品美国橙皮书
33-12苹果酸卡博替尼胶囊Cabozantinib S-Malate CapsulesCometriq20mgExelixis Inc未进口原研药品美国橙皮书
33-13苹果酸卡博替尼胶囊Cabozantinib S-Malate CapsulesCometriq80mgExelixis Inc未进口原研药品美国橙皮书
33-14吸入用雷芬那辛溶液Revefenacin inhalation solutionYupelri3ml:175µgMylan Ireland Ltd未进口原研药品美国橙皮书
33-15草酸艾司西酞普兰口服溶液Escitalopram Oxalate Solution-1mg/mlHetero Labs Limited Unit III国际公认的同种药品美国橙皮书
33-16氢溴酸加兰他敏片Galantamine Hydrobromide TabletsRazadyne4mg(按加兰他敏计)Janssen Pharmaceuticals Inc未进口原研药品美国橙皮书
33-17氢溴酸加兰他敏片Galantamine Hydrobromide TabletsRazadyne8mg(按加兰他敏计)Janssen Pharmaceuticals Inc未进口原研药品美国橙皮书
33-18氢溴酸加兰他敏片Galantamine Hydrobromide TablesRazadyne12mg(按加兰他敏计)Janssen Pharmaceuticals Inc未进口原研药品美国橙皮书
33-19氢溴酸加兰他敏片Galantamine Hydrobromide TablesRazadyne4mg(按加兰他敏计)Janssen Pharmaceutical K.K未进口原研药品日本上市
33-20氢溴酸加兰他敏片Galantamine Hydrobromide TablesRazadyne8mg(按加兰他敏计)Janssen Pharmaceutical K.K未进口原研药品日本上市
33-21氢溴酸加兰他敏片Galantamine Hydrobromide TablesRazadyne12mg(按加兰他敏计)Janssen Pharmaceutical K.K未进口原研药品日本上市
33-22培哚普利吲达帕胺氨氯地平片Perindopril Arginine/Indapamide/Amlodipine Besylate TabletsCoverdine5mg/1.25mg/5mgLes Laboratoires Servier(Ireland)Industries Ltd未进口原研药品欧盟上市
33-23培哚普利吲达帕胺氨氯地平片Perindopril Arginine/Indapamide/Amlodipine Besylate TabletsCoverdine10mg/2.5mg/5mgLes Laboratoires Servier(Ireland)Industries Ltd未进口原研药品欧盟上市
33-24乙酰半胱氨酸口服溶液Acetylcysteine Oral SolutionFluimucil2%(50ml、100ml、200ml)Zambon GmbH未进口原研药品欧盟上市
33-25注射用氯诺昔康Lornoxicam for InjectionXefo8mgTakeda Austria GmbH未进口原研产品欧盟上市
33-26盐酸依匹斯汀滴眼液Epinastine Hydrochloride Eye DropsRelestat0.5mg/ml(5ml)Allergan Pharmaceuticals Ireland未进口原研产品欧盟上市
33-27利伐沙班细粒剂Rivaroxaban Fine GranulesXarelto10mgバイエル薬品株式会社未进口原研药品日本上市
33-28利伐沙班细粒剂Rivaroxaban Fine GranulesXarelto15mgバイエル薬品株式会社未进口原研药品日本上市
33-29舒林酸片Sulindac TabletsClinoril100mg日医工株式会社未进口原研药品日本上市
33-30盐酸美金刚口崩片Memantine Hydrochloride OD TabletsMemary5mg第一三共株式会社未进口原研药品日本上市
33-31盐酸美金刚口崩片Memantine Hydrochloride OD TabletsMemary10mg第一三共株式会社未进口原研药品日本上市
33-32盐酸美金刚口崩片Memantine Hydrochloride OD TabletsMemary20mg第一三共株式会社未进口原研药品日本上市
33-33薄荷脑口服溶液Minclea Catapasm for Internal Use 0.8%-160mg/20ml日本製薬株式会社/Nihon Pharmaceutical Co., LTD.未进口原研药品日本上市
33-34注射用头孢他啶Ceftazidime for InjectionFortum(复达欣)0.5gGlaxoSmithKline国内上市的原研药品原研进口
33-35替米沙坦氢氯噻嗪片Telmisartan and Hydrochlorothiazide TabletsMicardis HCT80mg/12.5mgBoehringer Ingelheim未进口原研药品美国橙皮书
33-36地拉罗司分散片Deferasirox Dispersible TabletsExjade0.125gNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
33-37地拉罗司分散片Deferasirox Dispersible TabletsExjade0.25gNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
33-38地拉罗司分散片Deferasirox Dispersible TabletsExjade0.5gNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
33-39依西美坦片Exemestane TabletsAromasin25mgPharmacia&Upjohn Company(Division of Pfizer Inc)未进口原研药品美国橙皮书
33-40盐酸丁螺环酮片Buspirone Hydrochloride Tablet-10mgTeva Pharmaceuticals USA Inc.
美国橙皮书
33-41洛匹那韦利托那韦片Lopinavir and Ritonavir TabletsKaletra200mg/50mgAbbVie Inc未进口原研药品美国橙皮书
33-42洛匹那韦利托那韦片Lopinavir and Ritonavir TabletsKaletra100mg/25mgAbbVie Inc未进口原研药品美国橙皮书
33-43注射用盐酸苯达莫司汀Bendamustine Hydrochloride For Injection Treanda100mgCephalon, Inc.未进口原研药品美国橙皮书
33-44注射用盐酸吉西他滨Gemcitabine Hydrochloride for InjectionGemzar0.2g(以吉西他滨计)Eli Lilly and CO未进口原研药品美国橙皮书
33-45注射用盐酸吉西他滨Gemcitabine Hydrochloride for InjectionGemzar1g(以吉西他滨计)Eli Lilly and CO未进口原研药品美国橙皮书
33-46甲苯磺酸索拉非尼片Sorafenib Tosylate TabletsNexavar0.2gBayer Healthcare Pharmaceuticals Inc未进口原研药品美国橙皮书
33-47盐酸米那普仑片Milnacipran Hydrochloride TabletsSavella12.5mg(以C15H22N2O·HCl计)Allergan Sales LLC未进口原研药品美国橙皮书
33-48盐酸米那普仑片Milnacipran Hydrochloride TabletsSavella25mg(以C15H22N2O·HCl计)Allergan Sales LLC未进口原研药品美国橙皮书
33-49盐酸米那普仑片Milnacipran Hydrochloride TabletsSavella50mg(以C15H22N2O·HCl计)Allergan Sales LLC未进口原研药品美国橙皮书
33-50盐酸米那普仑片Milnacipran Hydrochloride TabletsSavella100mg(以C15H22N2O·HCl计)Allergan Sales LLC未进口原研药品美国橙皮书
33-51辛伐他汀片Simvastatin TabletsZocor10mgMSD Sharp &Dohme GmbH/Merck Sharp & Dohme Corp/Merck Sharp &Dohme Limited未进口原研药品欧盟上市
33-52沙美特罗替卡松吸入气雾剂Salmeterol Xinafoate and Fluticasone Propionate Inhalation AerosolAtmadisc25µg/125µg/揿,120揿/瓶GlaxoSmithKline GmbH & Co.KG未进口原研药品欧盟上市
33-53磷酸奥司他韦干混悬剂Oseltamivir Phosphate For Oral SuspensionTamiflu6mg/mlRoche Registration GmbH未进口原研药品欧盟上市
33-54贝美前列素滴眼液Bimatoprost Eye DropsLumigan0.3mg/ml(0.4ml)Allergan Pharmaceuticals Ireland未进口原研药品欧盟上市
33-55达可替尼片Dacomitinib Tablets Vizimpro45mgPfizer Europe MA EEIG未进口原研药品欧盟上市
33-56普瑞巴林胶囊Pregabalin CapsulesLyrica75mgPfizer未进口原研药品欧盟上市
33-57普瑞巴林胶囊Pregabalin CapsulesLyrica0.3gPfizer未进口原研药品欧盟上市
33-58来氟米特片Leflunomide TabletsArava20mgSanofi-aventis Deutschland GmbH未进口原研药品欧盟上市
33-59卡络磺钠注射液Carbosulfan Sodium injectionAdona50mg/10mlニプロESファーマ株式会社未进口原研药品日本上市
33-60马来酸伊索拉定片Irsogladine Maleate TabletsGaslon N2mgNippon Shinyaku Co.,Ltd.未进口原研药品日本上市
33-61盐酸罗沙替丁醋酸酯缓释胶囊Roxatidine Acetate Hydrochloride Sustained Release CapsulesAltat37.5mgあすか製薬株式会社未进口原研药品日本上市
33-62盐酸二甲双胍缓释片Metformin Hydrochloride Extended-release TabletsGlucophage SR0.75gMerck Serono Ltd未进口原研药品英国上市
33-63别嘌醇片Allopurinol TabletsZyloric0.1gAspen Pharma Trading Limited未进口原研药品英国上市
3-26阿奇霉素片Azithromycin Tablets-250mgTeva Pharma B.V. /Teva Nederland B.V.欧盟上市增加持证商Teva Nederland B.V
11-32头孢克洛胶囊Cefaclor Capsules希刻劳0.25g礼来苏州制药有限公司/苏州西克罗制药有限公司原研地产化品种持证商发生变更,增加持证商:苏州西克罗制药有限公司
12-32头孢克洛干混悬剂Cefaclor for Suspension希刻劳0.125g礼来苏州制药有限公司/苏州西克罗制药有限公司原研地产化品种持证商发生变更,增加持证商:苏州西克罗制药有限公司
14-16头孢克洛缓释片(Ⅱ)Cefaclor Sustained Release Tablets(Ⅱ)希刻劳0.375g礼来苏州制药有限公司/苏州西克罗制药有限公司原研地产化品种持证商发生变更,增加持证商:苏州西克罗制药有限公司
22-171米力农注射液Milrinone InjectionCorotrop10mg/10mlSanofi-Aventis France /Sanofi-Aventis (Schweiz) AG未进口原研药品增加持证商Sanofi-Aventis (Schweiz) AG
22-347盐酸多柔比星脂质体注射液Doxorubicin Hydrochloride Liposome InjectionDoxil (Liposomal)20mg/10ml(2mg/ml)Janssen Research And Development Llc/Baxter Healthcare Corp未进口原研药品持证商发生变更,增加持证商Baxter Healthcare Corp
22-348盐酸多柔比星脂质体注射液Doxorubicin Hydrochloride Liposome InjectionDoxil (Liposomal)50mg/25ml(2mg/ml)Janssen Research And Development Llc/Baxter Healthcare Corp未进口原研药品持证商发生变更,增加持证商Baxter Healthcare Corp
22-503注射用头孢他啶Ceftazidime for InjectionGlazidim500mgGlaxoSmithKline/GlaxoSmithKline S.p.A未进口原研药品增加持证商GlaxoSmithKline S.p.A
26-109伏立康唑片Voriconazole TabletsVfend50mgPfizer Europe Ma EEIG /Pfizer Inc未进口原研药品增加持证商Pfizer Inc
27-189比拉斯汀片Bilastine Tablets-20mgMenarini International Operations Luxembourg S.A./Faes Farma, S.A.未进口原研药品不限定商品名
30-104舒必利片Sulpiride TabletsDogmatyl0.1gAstellas Pharma Inc未进口原研药品商品名修订为Dogmatyl


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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