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【第二十八批】仿制药参比制剂目录


【第二十八批】仿制药参比制剂目录


序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2
28-1富马酸依美斯汀滴眼液Emedastine Difumarate Eye Drops/Emadine0.5mg/ml(5ml,10ml,0.35ml)眼用制剂Novartis Europharm Limited未进口原研药品欧盟上市
28-2对乙酰氨基酚注射液Paracetamol Injection/Perfalgan10mg/ml(1g/100ml)注射剂Bristol- Myers Squibb未进口原研药品欧盟上市
28-3钆布醇注射液Gadobutrol Injection/Gadavist9.0708g/15ml (604.72mg/ml)注射剂Bayer Healthcare Pharmaceuticals Inc未进口原研药品美国橙皮书
28-4硫酸氢氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets /Plavix75mg片剂Sanofi Clir SNC未进口原研药品欧盟上市
28-5氨基酸(16AA-II)/葡萄糖(48%)电解质注射液Compound Amino Acid(16AA-II), Glucose(48%) and Electrolyte Injection/ Nutriflex special (70/240)1000ml,1500ml注射剂B.Braun Medical AG未进口原研药品瑞士上市
28-6达肝素钠注射液Dalteparin Sodium Injection/Fragmin7,500IU/0.3ml(25,000IU/ml)注射剂Pfizer Inc未进口原研药品美国橙皮书
28-7马来酸阿法替尼片Afatinib Dimaleate Tablets/Giotrif20mg片剂Boehringer Ingelheim International GmbH未进口原研药品欧盟上市
28-8注射用多黏菌素E甲磺酸钠Colistimethate Sodium for Injection/Colomycin200万IU注射剂Teva未进口原研药品欧盟上市
28-9盐酸曲恩汀片Trientine Hydrochloride Tablets/Cuprior150 mg(以C6H18N4计)片剂GMP-Orphan SA未进口原研药品欧盟集中上市
28-10维A酸乳膏Tretinoin Cream/Retin-A0.03%(包装规格20g、45g)乳膏剂Valeant International Bermuda未进口原研药品美国橙皮书
28-11维A酸乳膏Tretinoin Cream/Retin-A0.10%(包装规格20g、45g)乳膏剂Valeant Pharmaceuticals North America LLC未进口原研药品美国橙皮书
28-12维A酸乳膏Tretinoin cream/ Renova0.02%(包装规格20g、40g、60g;泵44g)乳膏剂Valeant Pharmaceuticals North America LLC未进口原研药品美国橙皮书
28-13盐酸替罗非班注射液Tirofiban Hydrochloride Injection/ Aggrastat(艾卡特)50ml:12.5mg注射剂Correvio Australia Pty Ltd国内上市的原研药品原研进口
28-14注射用盐酸多西环素Doxycycline Hyclate for Injection/Doxy 200200mg/Vial注射剂Fresenius Kabi USA LLC国际公认的同种药品美国橙皮书
28-15西他沙星片Sitafloxacin Tablets /GRACEVIT50mg片剂Daiichi Sankyo Co., Ltd.未进口原研药品日本橙皮书
28-16盐酸伐地那非片Vardenafil Hydrochloride Tablets/Levitra5mg片剂Bayer Healthcare Pharmaceuticals Inc未进口原研药品美国橙皮书
28-17盐酸伐地那非片Vardenafil Hydrochloride Tablets/Levitra10mg片剂Bayer Healthcare Pharmaceuticals Inc未进口原研药品美国橙皮书
28-18盐酸伐地那非片Vardenafil Hydrochloride Tablets/Levitra20mg片剂Bayer Healthcare Pharmaceuticals Inc未进口原研药品美国橙皮书
28-19塞来昔布胶囊Celecoxib Capsules/Celebrex100mg胶囊剂G.D. Searle LLC未进口原研药品美国橙皮书
28-20塞来昔布胶囊Celecoxib Capsules/Celebrex200mg胶囊剂G.D. Searle LLC未进口原研药品美国橙皮书
28-21塞来昔布胶囊Celecoxib Capsules/Celebrex400mg胶囊剂G.D. Searle LLC未进口原研药品美国橙皮书
28-22妥洛特罗贴剂Tulobuterol Patch/Amiaid(阿米迪)0.5mg/贴贴剂日东电工株式会社国内上市的原研药品原研进口
28-23妥洛特罗贴剂Tulobuterol Patch/Amiaid(阿米迪)1mg/贴贴剂日东电工株式会社国内上市的原研药品原研进口
28-24妥洛特罗贴剂Tulobuterol Patch/Amiaid(阿米迪)2mg/贴贴剂日东电工株式会社国内上市的原研药品原研进口
28-25盐酸达泊西汀片Dapoxetine Hydrochloride Tablets/ Priligy60mg片剂Berlin-Chemie AG/ A. Menarini Industrie Farmaceutiche Riunite s.r.l未进口原研药品欧盟上市
28-26甲苯磺酸艾多沙班片Edoxaban Tablets/Lixiana15mg(以艾多沙班计)片剂Daiichi Sankyo Europe GmbH未进口原研药品欧盟上市
28-27甲苯磺酸艾多沙班片Edoxaban Tablets/Lixiana30mg(以艾多沙班计)片剂Daiichi Sankyo Europe GmbH未进口原研药品欧盟上市
28-28甲苯磺酸艾多沙班片Edoxaban Tablets/Lixiana60mg(以艾多沙班计)片剂Daiichi Sankyo Europe GmbH未进口原研药品欧盟上市
28-29硫酸阿托品注射液Atropine Sulfate Injection1ml:0.5mg注射剂田辺三菱製薬株式会社/ニプロESファーマ株式会社
日本上市

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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