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【第六批】仿制药参比制剂目录


【第六批】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
6-1草酸艾司西酞普兰片Escitalopram Oxalate Tablets/Lexapro5mg(按C20H21FN2O计)片剂H. Lundbeck A/S原研进口
6-2草酸艾司西酞普兰片Escitalopram Oxalate Tablets/Lexapro10mg(按C20H21FN2O计)片剂H. Lundbeck A/S原研进口
6-3草酸艾司西酞普兰片Escitalopram Oxalate Tablets/Lexapro20mg(按C20H21FN2O计)片剂H. Lundbeck A/S原研进口
6-4多潘立酮口崩片Domperidone Orally Disintegrating Tablets/Motilium10mg片剂Janssen-Cilag AG - Switzerland欧盟上市 ( 上市国家:瑞士;产地:英国)瑞士上市名称:Domperidone Orodispersible Tablets
6-5恩替卡韦片Entecavir Tablets /BARACLUDE0.5mg片剂BRISTOL MYERS SQUIBB美国橙皮书
6-6恩替卡韦片Entecavir Tablets /BARACLUDE1mg片剂BRISTOL MYERS SQUIBB美国橙皮书
6-7红霉素肠溶片Erythromycin Enteric-coated Tablets/ERY-TAB0.5g(50万单位)片剂Arbor Pharmaceuticals LLC美国橙皮书美国上市名称:Erythromycin delayed-release tablets
6-8甲磺酸倍他司汀片Betahistine Mesilate Tablets/Merislon6mg片剂Eisai Co., Ltd.日本橙皮书
6-9利培酮片Risperidone Tablets/Risperdal3mg片剂Janssen Pharmaceuticals Inc美国橙皮书
6-10磷酸奥司他韦胶囊 Oseltamivir  Phosphate Capsules/ Tamiflu75mg(按C16H28N2O4计)胶囊剂Roche Registration Ltd.原研进口
6-11硫酸氨基葡萄糖胶囊Glucosamine Sulfate Capsules/Viartril-S0.25g(以硫酸氨基葡萄糖计)胶囊剂ROTTAPHARM S.P.A原研进口适用于:含氯化钠的硫酸氨基葡萄糖混合物
6-12硫酸羟氯喹片 Hydroxychloroquine Sulfate Tablets/Plaquenil0.2g片剂Aventis Pharma Limited原研进口
6-13匹伐他汀钙片Pitavastatin CalciumTablets /Livalo Kowa1mg片剂 Kowa Company, Ltd.原研进口
6-14匹伐他汀钙片Pitavastatin CalciumTablets /Livalo Kowa2mg片剂 Kowa Company, Ltd.原研进口
6-15氢溴酸西酞普兰片Citalopram Hydrobromide Tablets/Cipramil20mg(按C20H21FN2O计)片剂H. Lundbeck A/S原研进口
6-16头孢地尼胶囊Cefdinir Capsules/Cefzon0.1g胶囊剂Astellas Pharma Inc.原研进口
6-17缬沙坦胶囊Valsartan Capsules/DIOVAN40mg胶囊剂Novartis Pharmaceuticals UK Limited欧盟上市(上市国家:英国;产地:瑞士)
6-18缬沙坦胶囊Valsartan Capsules/DIOVAN0.16g胶囊剂Novartis Pharmaceuticals UK Limited欧盟上市(上市国家:英国;产地:瑞士)
6-19缬沙坦片Valsartan Tablets/DIOVAN0.16g片剂NOVARTIS PHARMACEUTICALS CORP美国橙皮书
6-20缬沙坦片Valsartan Tablets/DIOVAN80mg片剂NOVARTIS PHARMACEUTICALS CORP美国橙皮书
6-21缬沙坦片Valsartan Tablets/DIOVAN40mg片剂NOVARTIS PHARMACEUTICALS CORP美国橙皮书
6-22盐酸乙胺丁醇片Ethambutol Hydrochloride Tablets/Myambutol0.4g片剂STI Pharma LLC美国橙皮书
6-23盐酸地尔硫䓬片Diltiazem  Hydrochloride  Tablets/ HERBESSER60mg片剂Mitsubishi Tanabe Pharma Corporation日本橙皮书
6-24盐酸二甲双胍缓释片Metformin Hydrochloride Sustained-release Tablets/GLUCOPHAGE XR0.5g片剂(缓释片)BRISTOL MYERS SQUIBB CO美国橙皮书
6-25盐酸二甲双胍片Metformin Hydrochloride Tablets/Glucophage0.85g片剂Merck  Santé S.A.S欧盟上市(上市国家:法国;产地:法国)
6-26盐酸雷尼替丁片Ranitidine Hydrochloride Tablets/Zantac 75mg(按 C13H22N403S计)片剂Glaxo SmithKline K.K日本橙皮书
6-27盐酸美西律胶囊Mexiletine Hydrochloride Capsules/Mexitil50mg胶囊剂Nippon Boehringer Ingelheim Co., Ltd.日本橙皮书
6-28盐酸美西律胶囊Mexiletine Hydrochloride Capsules/Mexitil0.1g胶囊剂Nippon Boehringer Ingelheim Co., Ltd.日本橙皮书
6-29盐酸特比萘芬片Terbinafine Hydrochloride Tablets/Lamisil0.125g(按C21H25N计)片剂Sun Pharmaceutical Industries Limited日本橙皮书
6-30盐酸特比萘芬片Terbinafine Hydrochloride Tablets/Lamisil0.25g(按C21H25N计)片剂NOVARTIS PHARMACEUTICALS CORP美国橙皮书
6-31盐酸西替利嗪口崩片Cetirizine Hydrochloride Orally Disintegrating Tablets/Zyrtec Allergy10mg片剂(口崩片)Johnson and Johnson Consumer Inc Mcneil Consumer Healthcare Division美国橙皮书
6-32盐酸西替利嗪片Cetirizine Hydrochloride Tablets/Zyrtec10mg片剂UCB-Pharma AG原研进口
6-33盐酸左西替利嗪片Levocetirizine Hydrochloride Tablets/Xyzal5mg片剂UCB Pharma AG原研进口
6-34硬脂酸红霉素片Erythromycin Stearate Tablets/ERYTHROCIN STEARATE0.25g(按C37H67NO13计,25万单位)片剂Arbor Pharmaceuticals LLC美国橙皮书
6-35阿司匹林肠溶胶囊Aspirin Enteric Capsules/Astrix0.1g胶囊剂(肠溶胶囊)Mayne Pharma International Pty Ltd上市国家:澳大利亚

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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