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【第五批】仿制药参比制剂目录


【第五批】仿制药参比制剂目录


序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2
5-1艾司唑仑片Estazolam Tablets/EURODIN1mg片剂Teva Takeda Yakuhin Ltd.日本橙皮书
5-2艾司唑仑片Estazolam Tablets/EURODIN2mg片剂Teva Takeda Yakuhin Ltd.日本橙皮书
5-3氨茶碱片Aminophylline Tablets/Neophyllin0.1g(按C2H8N2(C7H8N4O2)2·2H2O计)片剂Sannova Co., Ltd.日本橙皮书日本上市名称:Aminophylline Hydrate Tablets
5-4丙硫氧嘧啶片Propylthiouracil Tablets/Propylthiouracil50mg片剂Dava Pharmaceuticals INC美国橙皮书
5-5醋酸甲地孕酮片Megestrol Acetate Tablets/Megace0.16g片剂PharmaSwiss  Česká republika s.r.o.欧盟上市(产地:英国)
5-6地高辛片Digoxin Tablets/Lanoxin0.25mg片剂Concordia Pharmaceuticals Inc美国橙皮书
5-7多潘立酮片Domperidone Tablets/Motilium10mg片剂Janssen-Cilag (Val de Reuil) France欧盟上市(上市国家:法国;产地:法国)法国上市名称:Domperidone Film-coated Tablets
5-8奋乃静片Perphenazine Tablets/PERPHENAZINE2mg片剂SANDOZ INC美国橙皮书
5-9奋乃静片Perphenazine Tablets/PERPHENAZINE4mg片剂SANDOZ INC美国橙皮书
5-10复方地芬诺酯片Compound Diphenoxylate Hydrochloride Tablets/Lomotil盐酸地芬诺酯2.5mg,硫酸阿托品25μg片剂GD SEARLE LLC美国橙皮书美国上市名称:diphenoxylate hydrochloride and atropine sulfate tablets
5-11格列本脲片Glibenclamide Tablets/Daonil2.5mg片剂sanofi K.K.日本橙皮书
5-12枸橼酸他莫昔芬片Tamoxifen Citrate Tablets/Nolvadex10mg(按他莫昔芬计)片剂Astrazeneca K.K.日本橙皮书
5-13红霉素肠溶胶囊Erythromycin Enteric Capsules/ERYC0.25g(25万单位)胶囊剂Mayne Pharma International Pty Ltd美国橙皮书美国上市名称:Erythromycin delayed-release capsules
5-14红霉素肠溶片Erythromycin Enteric-coated Tablets/ERY-TAB0.25g(25万单位)片剂Arbor Pharmaceuticals LLC美国橙皮书美国上市名称:Erythromycin delayed-release tablets
5-15琥珀酸亚铁片Ferrous Succinate Tablets/INOFER0.1g片剂LABORATOIRE DE L’ INOFER欧盟上市(上市国家:法国;产地:法国)
5-16华法林钠片Warfarin Sodium Tablets/Coumadin2.5mg片剂Bristol Myers Squibb Pharma Co美国橙皮书
5-17华法林钠片Warfarin Sodium Tablets/Coumadin5mg片剂Bristol Myers Squibb Pharma Co美国橙皮书
5-18己烯雌酚片Diethylstilbestrol Tablets /DISTILBENE1mg片剂LABORATOIRES GERDA欧盟上市(上市国家:法国;产地:法国)
5-19卡托普利片Captopril Tablets/CAPTORIL 12.5mg片剂Daiichi Sankyo Espha Co.,  Ltd.日本橙皮书
5-20卡托普利片Captopril Tablets/CAPTORIL 25mg片剂Daiichi Sankyo Espha Co.,  Ltd.日本橙皮书
5-21利培酮片Risperidone Tablets/Risperdal1mg片剂Janssen Pharmaceuticals Inc美国橙皮书
5-22利培酮片Risperidone Tablets/Risperdal2mg片剂Janssen Pharmaceuticals Inc美国橙皮书
5-23柳氮磺吡啶肠溶片Sulfasalazine Enteric-coated Tablets/Azulfidine0.25g片剂(肠溶片)Pfizer Japan Inc.日本橙皮书日本上市名称Salazosulfapyridine Enteric-coated Tablets
5-24马来酸多潘立酮片Domperidone Maleate Tablets/Motilium10mg(按C22H24ClN5O2计)片剂Johnson & Johnson Consumer N.V./S.A.-Belgium欧盟上市 ( 上市国家:比利时;产地:法国)比利时上市名称:Domperidone Maleate Film-coated Tablets
5-25麦角胺咖啡因片Ergotamine  and Caffeine Tablets/CAFERGOT酒石酸麦角胺1mg,无水咖啡因100mg片剂SANDOZ INC美国橙皮书美国上市名称:Ergotamine Tartrate and Caffeine Tablets
5-26蒙脱石散Montmorillonite Powder/SMECTA3g散剂IPSEN PHARMA欧盟上市(上市国家:法国;产地:法国)
5-27米非司酮片 Mifepristone Tablets/Mifegyne0.2g片剂EXELGYN欧盟上市(上市国家:法国;产地:法国)
5-28诺氟沙星片Norfloxacin Tablets/BACCIDAL0.1g片剂KYORIN Pharmaceutical Co.,Ltd.日本橙皮书
5-29氢化可的松片Hydrocortisone Tablets/Cortef10mg片剂PHARMACIA AND UPJOHN CO美国橙皮书
5-30氢化可的松片Hydrocortisone Tablets/Cortef20mg片剂PHARMACIA AND UPJOHN CO美国橙皮书
5-31舒必利片Sulpiride Tablets/Abilit0.1g片剂Dainippon Sumitomo Pharma Co., Ltd.日本橙皮书
5-32舒必利片Sulpiride Tablets/Abilit50mg片剂Dainippon Sumitomo Pharma Co., Ltd.日本橙皮书
5-33替加氟胶囊Tegafur Capsules/Futraful0.2g胶囊剂TAIHO PHARMACEUTICAL CO., LTD.日本橙皮书
5-34替硝唑片Tinidazole Tablets/Fasigyn0.5g片剂Pfizer Limited欧盟上市(上市国家:英国;产地:法国)
5-35硝酸异山梨酯片Isosorbide Dinitrate Tablets/ISORDIL5mg片剂VALEANT PHARMACEUTICALS NORTH AMERICA LLC美国橙皮书
5-36盐酸地尔硫䓬片Diltiazem  Hydrochloride  Tablets/ HERBESSER30mg片剂Mitsubishi Tanabe Pharma Corporation日本橙皮书
5-37盐酸二甲双胍片Metformin Hydrochloride Tablets/Glycoran0.25g片剂NIPPON SHINYAKU CO.,LTD.日本橙皮书
5-38盐酸二甲双胍片Metformin Hydrochloride Tablets/Glucophage0.5g片剂Merck  Santé S.A.S欧盟上市(上市国家:法国;产地:法国)
5-39盐酸雷尼替丁胶囊Ranitidine Hydrochloride Capsules/RANITIDINE HYDROCHLORIDE0.15g(按C13H22N403S计)胶囊剂SANDOZ INC美国橙皮书
5-40盐酸雷尼替丁片Ranitidine Hydrochloride Tablets/Zantac0.15g(按C13H22N403S计)片剂Glaxo SmithKline UK欧盟上市:(上市国家:英国;产地:德国)
5-41盐酸美西律片Mexiletine Hydrochloride Tablets/Mexiletine Hydrochloride50mg片剂KYOWA CritiCare Co., Ltd日本橙皮书
5-42盐酸美西律片Mexiletine Hydrochloride Tablets/Mexiletine Hydrochloride0.1g片剂KYOWA CritiCare Co., Ltd日本橙皮书
5-43盐酸帕罗西汀片Paroxetine Hydrochloride/Paxil20mg(按C19H20FNO3计)片剂Apotex Technologies Inc美国橙皮书
5-44盐酸乙胺丁醇片Ethambutol Hydrochloride Tables/Ebutol0.25g片剂Kaken Pharmaceutical Co.,Ltd.日本橙皮书
5-45异烟肼片Isoniazid Tablets/Isoniazid0.3g片剂SANDOZ INC美国橙皮书
5-46异烟肼片Isoniazid Tablets/Isoniazid0.1g片剂SANDOZ INC美国橙皮书
5-47盐酸普萘洛尔片Propranolol Hydrochloride Tablets/Inderal10mg片剂AstraZeneca K.K.日本橙皮书
5-48丙硫氧嘧啶片Propylthiouracil Tablets/PROPYL-THYRACIL0.1g片剂Paladin Labs Inc上市国家:加拿大
5-49磷酸氯喹片Chloroquine Phosphate Tablets/Resochin0.25g(按氯喹C18H26ClN3计155mg)片剂Bayer Vital GmbH欧盟上市(上市国家:德国;产地:德国

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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