仿制药参比制剂目录（第36批）

1、附件仿制药参比制剂目录（第三十六批）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 36-1碘普罗胺注射液Iopromide Injection/ Ultravist（优维显）100ml:76.89gBayer Vital GmbH国内上市的原研药品原研进口36-2利奥西呱片Riociguat Tablets/ Adempas （安吉奥）0.5mgBayer AG国内上市的原研药品原研进口36-3利奥西呱片Riociguat Tablets/ Adempas （安吉奥）1mgBayer AG国内上市的原研药品原研进口36-4利奥西呱片Riociguat Tablets/ Adempas

2、 （安吉奥）2.5mgBayer AG国内上市的原研药品原研进口36-5塞瑞替尼胶囊Ceritinib Capsules / Zykadia（赞可达）150mgNovartis Europharm Limited国内上市的原研药品原研进口36-6吸入用伊洛前列素溶液Iloprost Solution for Inhalation/ Ventavis（万他维）2ml:20gBayer AG国内上市的原研药品原研进口36-7倍氯米松福莫特罗吸入气雾剂Beclometasone Dipropionate and Formoterol Inhalation Aerosol每瓶120揿,每揿含丙酸倍氯米

3、松100g和富马酸福莫特罗6gChiesi Farmaceutici SPA国内上市的原研药品原研进口36-8骨化三醇注射液Calcitriol Injection/ Calcijex（溉纯）1ml:1gAbbVie Pte. Ltd.国内上市的原研药品原研进口36-9吡仑帕奈片Perampanel Tablets/Fycompa（卫克泰）2mgEisai Europe Limited国内上市的原研药品原研进口36-10吡仑帕奈片Perampanel Tablets/Fycompa（卫克泰）4mgEisai Europe Limited国内上市的原研药品原研进口36-11吡仑帕奈片Peramp

4、anel Tablets/Fycompa2mgEisai Inc未进口原研药品美国橙皮书36-12吡仑帕奈片Perampanel Tablets/Fycompa4mgEisai Inc未进口原研药品美国橙皮书36-13贝派度酸片Bempedoic Acid Tablets180mgEsperion Therapeutics Inc未进口原研药品美国橙皮书36-14来氟米林注射液lefamulin Injection/Xenleta150mg /15mL （10mg /mL）Nabriva Therapeutics Ireland DAC未进口原研药品美国橙皮书36-15硫酸长春新碱注射液Vin

5、criscristine Sulfate Injection1mg/mlHospira, Inc国际公认同种药品美国橙皮书36-16哌柏西利片Palbociclib Tablets/Ibrance75mgPfizer Inc未进口原研药品美国橙皮书36-17哌柏西利片Palbociclib Tablets/Ibrance100mgPfizer Inc未进口原研药品美国橙皮书36-18哌柏西利片Palbociclib Tablets/Ibrance125mgPfizer inc未进口原研药品美国橙皮书36-19伊布替尼片Ibrutinib Tablets/Imbruvica420mgPharma

6、cyclics LLC未进口原研药品美国橙皮书36-20伊布替尼片Ibrutinib Tablets/Imbruvica280mgPharmacyclics LLC未进口原研药品美国橙皮书36-21伊布替尼片Ibrutinib Tablets/Imbruvica140mgPharmacyclics LLC未进口原研药品美国橙皮书36-22伊布替尼片Ibrutinib Tablets/Imbruvica560mgPharmacyclics LLC未进口原研药品美国橙皮书36-23洛度沙胺氨丁三醇滴眼液Lodoxamide Tromethamine Ophthalmic Solution /Alo

7、mide0.10%Novartis Pharmaceuticals Corp未进口原研药品美国橙皮书36-24左卡尼汀片Levocarnitine Tablets/Carnitor330mgLeadiant Biosciences Inc未进口原研药品美国橙皮书36-25艾拉戈克钠片Elagolix Sodium Tablets/ Orilissa150mgAbbVie Inc.未进口原研药品美国橙皮书36-26艾拉戈克钠片Elagolix Sodium Tablets/ Orilissa200mgAbbVie Inc.未进口原研药品美国橙皮书36-27注射用马来酸匹杉琼Pixantrone

8、injection/Pixuvri29mgLes Laboratoires Servier未进口原研药品欧盟上市36-28右酮洛芬氨丁三醇注射液Dexketoprofen Trometamol Injection / Enantyum2ml:50mg（以右酮洛芬计）Laboratorios Menarini，S.A.未进口原研药品欧盟上市36-29普罗雌烯乳膏Promestriene Cream/Colpotrophine1g:0.01gTheramex Ireland Limited未进口原研药品欧盟上市36-30依托孕烯炔雌醇阴道环Etonogestrel and Ethinylestra

9、diol Vaginal Ring依托孕烯11.7mg; 炔雌醇2.7mgN.V. Organon 未进口原研药品欧盟上市36-31雷马曲班片Ramatroban Tablets/ Baynas50mg薬品株式会社未进口原研药品日本上市36-32雷马曲班片Ramatroban Tablets/ Baynas75mg薬品株式会社未进口原研药品日本上市36-33肠外营养注射液（25）Total Parenteral Nutrition Injection（25） / Pntwin1000ml株式会社未进口原研药品日本上市36-34他克莫司缓释胶囊Tacrolimus Sustained-relea

10、se Capsules/新普乐可复0.5mgAstellas Pharma Europe B.V.国内上市的原研药品原研进口36-35他克莫司缓释胶囊Tacrolimus Sustained-release Capsules/新普乐可复1mgAstellas Pharma Europe B.V.国内上市的原研药品原研进口36-36注射用硼替佐米Bortezomib For Injection/Velcade3.5mgMillennium Pharmaceuticals Inc未进口原研药品美国橙皮书36-37塞来昔布胶囊Celecoxib Capsules/Celebrex50mgG.D. S

11、earle LLC未进口原研药品美国橙皮书36-38舒更葡糖钠注射液Sugammadex Sodium Injection/Bridion200mg/2mlOrganon USA Inc A Sub Of Merck And Co Inc未进口原研药品美国橙皮书36-39盐酸帕罗西汀肠溶缓释片Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets/Paxil Cr37.5mgApotex Technologies Inc未进口原研药品美国橙皮书36-40注射用硫酸艾莎康唑Isavuconazonium Sulfate

12、for Injection/Cresemba372mg（按艾沙康唑计200mg）Astellas Pharma US, Inc.未进口原研药品美国橙皮书36-41骨化三醇软胶囊Calcitriol Soft Capsules/Rocaltrol0.25gValidus Pharmaceuticals LLC未进口原研产品美国橙皮书36-42琥珀酸美托洛尔缓释片Metoprolol Succinate Extended-release/Toprol-Xl25mg（以酒石酸美托洛尔计）Toprol Acquisition LLC未进口原研产品美国橙皮书36-43达沙替尼片Dasatinib Tab

13、lets /Sprycel20mgBristol-Myers Squibb Pharma EEIG未进口原研药品欧盟上市36-44达沙替尼片Dasatinib Tablets /Sprycel50mgBristol-Myers Squibb Pharma EEIG未进口原研药品欧盟上市36-45达沙替尼片Dasatinib Tablets /Sprycel70mgBristol-Myers Squibb Pharma EEIG未进口原研药品欧盟上市36-46达沙替尼片Dasatinib Tablets /Sprycel100mgBristol-Myers Squibb Pharma EEIG未

14、进口原研药品欧盟上市36-47达沙替尼片Dasatinib Tablets /Sprycel140mgBristol-Myers Squibb Pharma EEIG未进口原研药品欧盟上市36-48普瑞巴林胶囊Pregabalin Capsules/Lyrica25mgPfizer未进口原研药品欧盟上市36-49普瑞巴林胶囊Pregabalin Capsules/Lyrica50mgPfizer未进口原研药品欧盟上市36-50普瑞巴林胶囊Pregabalin Capsules/Lyrica150mgPfizer未进口原研药品欧盟上市36-51普瑞巴林胶囊Pregabalin Capsules/

15、Lyrica200mgPfizer未进口原研药品欧盟上市36-52普瑞巴林胶囊Pregabalin Capsules/Lyrica225mgPfizer未进口原研药品欧盟上市36-53注射用醋酸卡泊芬净Caspofungin Acetate for Injection/Cancidas50mgMerck Sharp & Dohme B.V. / Merck Sharp & Dohme Limited未进口原研药品欧盟上市36-54注射用醋酸卡泊芬净Caspofungin Acetate for Injection/Cancidas70mgMerck Sharp & Do

16、hme B.V. / Merck Sharp & Dohme Limited未进口原研药品欧盟上市36-55阿卡波糖片Acarbose Tablets/Glucobay100mgBayer Vital Gmbh未进口原研药品欧盟上市36-56糠酸莫米松鼻喷雾剂Mometasone Furoate Aqueous Nasal Spray/Nasonex50g/揿（0.05%）MSD SHARP & DOHME GMBH/MSD France/MSD Italia S.r.l./Merck Sharp & Dohme BV未进口原研药品欧盟上市36-57多西他赛注射液Doc

17、etaxel Injection/Taxotere1ml:20mgSanofi K.K./株式会社未进口原研药品日本上市36-58苯甲酸阿格列汀片Alogliptin Benzoate Tablets/Nesina12.5mg武田薬品工業株式会社未进口原研药品日本上市36-59注射用盐酸表柔比星Epirubicin Hydrochloride for Injection/Farmorubicin50mg株式会社未进口原研药品日本上市10-12单硝酸异山梨酯缓释胶囊Isosorbide Mononitrate Sustained-release Capsules/Elantan50mgUCB P

18、harma/Norgine Pharmaceuticals Limited/Merus Labs Luxco II S.à.R.L/Yinglian Health Pharmaceutical GmbH欧盟上市持证商发生变更，增加持证商Yinglian Health Pharmaceutical GmbH22-356头孢地尼细粒剂Cefdinir Fine Granules/Cefzon50mg/0.5gAstellaspharma Inc./LTL株式会社未进口原研药品增加持证商LTL株式会社22-475依托考昔片Etoricoxib Tablets /Arcoxia 30mgMerck SharpDohme B.V./Merck Sharp & Dohme Limited未进口原研药品持证商发生变更，增加新持证商Merck Sharp&Dohme Limited22-476依托考昔片Etoricoxib Tablets /Arcoxia 90mgMerck SharpDohme B.V./Merck Sharp