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CFDA仿制药参比制剂目录(第一批)

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  • 分类:学术资料
  • 更新时间:2017-03-31
  • 大小:0.02MB
  • 语言:中文
  • 来源:CFDA
  • 内容说明:

    国家食品药品监督管理总局于2017年3月17日发布的仿制药药参比制剂目录(第一批)。

    仿制药参比制剂目录(第一批)

    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
    1-1盐酸胺碘酮片Amiodarone Hydrochloride Tablets/Cordarone0.2g片剂 Sanofi-Aventis France原研进口  
    1-2阿卡波糖片Acarbose Tablets/Glucobay50mg片剂 Bayer Vital GmbH原研进口  
    1-3尼莫地平片 Nimodipine Tablets/Nimotop30mg 片剂 Bayer Vital GmbH 原研进口  
    1-4头孢呋辛酯片Cefuroxime Axetil Tablets/Ceftin按头孢呋辛(C16H16N4O8S)计0.125g片剂 GlaxoSmithKline美国橙皮书 
    1-5头孢呋辛酯片Cefuroxime Axetil Tablets/Zinacef按头孢呋辛(C16H16N4O8S)计0.25g片剂 Glaxo Wele UK Limited原研进口  
    1-6辛伐他汀片Simvastatin Tablets/Zocor10mg片剂 Merck Sharp & Dohme (Australia) Pty. Ltd.原研进口  
    1-7辛伐他汀片Simvastatin Tablets/Zocor20mg片剂 Merck Sharp & Dohme B.V.原研进口  
    1-8盐酸氨溴索片Ambroxol Hydrochloride Tablets/Mucosolvan30mg片剂 Boehringer Ingelheim France原研进口  
    1-9聚乙二醇4000散Macrogol 4000 powder/Forlax10g散剂Ipsen Pharma原研进口  
    1-10醋酸去氨加压素片Desmopressin Acetate Tablets/Minirin0.1mg 片剂Ferring AG 原研进口 
    1-11醋酸去氨加压素片Desmopressin Acetate Tablets/Minirin0.2mg 片剂Ferring AG 原研进口 
    1-12富马酸比索洛尔片Bisoprolol Fumarate Tablets/ Concor2.5mg片剂Merck Serono GmbH原研进口 
    1-13富马酸比索洛尔片Bisoprolol Fumarate Tablets/ Concor5mg片剂Merck Serono GmbH原研进口 
    1-14白消安片Busulfan Tablets/Myleran2mg片剂Aspen Pharmacare Australia Pty Ltd原研进口 
    1-15富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel25mg片剂AstraZeneca UK Limited原研进口 
    1-16富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel0.1g片剂AstraZeneca UK Limited原研进口 
    1-17醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets/Provera 0.1g片剂Pfizer SA/NV原研进口 
    1-18醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets/Provera 0.25g片剂Pfizer Italia s.r.l欧盟上市(产地:意大利) 
    1-19阿莫西林克拉维酸钾片Amoxicillin and Clavulanate Potassium Tablets/Augmentin 0.375g(C16H19N3O5S 0.25g与C8H9NO5 0.125g)片剂Beecham Group Plc欧盟上市(产地:英国;上市国家:英国) 
    1-20阿莫西林克拉维酸钾片Amoxicillin and Clavulanate Potassium Tablets/Augmentin0.625g(C16H19N3O5S 0.5g与C8H9NO5 0.125g)片剂Beecham Group Plc原研进口 
    1-21阿莫西林克拉维酸钾片Amoxicillin and Clavulanate Potassium Tablets/Augmentin1g(C16H19N3O5S 0.875g与C8H9NO5 0.125g)片剂Beecham Group Plc原研进口 
    1-22格列美脲片Glimepiride Tablets/Amaryl1mg 片剂 Sanofi-Aventis Deutschland GmbH原研进口  
    1-23格列美脲片Glimepiride Tablets/Amaryl2mg片剂 Sanofi-Aventis Deutschland GmbH原研进口  
    1-24环孢素软胶囊Ciclosporin Soft Capsules/Sandimmun Neoral10mg胶囊剂(软胶囊)Novartis Pharma Schweiz AG 原研进口  
    1-25环孢素软胶囊Ciclosporin Soft Capsules/Sandimmun Neoral25mg胶囊剂(软胶囊)Novartis Pharma Schweiz AG 原研进口  
    1-26环孢素软胶囊Ciclosporin Soft Capsules/Sandimmun Neoral50mg胶囊剂(软胶囊)Novartis Pharma Schweiz AG 原研进口  
    1-27甲巯咪唑片Thiamazole Tablets/Thyrozol5mg片剂 Merck Serono GmbH原研进口  
    1-28硫酸氢氯吡格雷片 Clopidogrel Hydrogen Sulphate Tablets/Plavix75mg片剂 Sanofi Clir SNC原研进口  
    1-29硝酸甘油舌下片Nitroglycerin Sublingual Tablets/ Nitrostat0.5mg片剂(舌下片)Pfizer INC原研进口 适用于硝酸甘油舌下片和舌下含服的硝酸甘油片
    1-30克拉霉素片Clarithromycin Tablets/Klacid0.25g片剂 ABBOTT LABORATORIES LIMITED原研进口  
    1-31阿立哌唑片Aripiprazole Tablets/Abilify5mg片剂 Otsuka Pharmaceutical Co. Ltd 美国橙皮书 
    1-32阿立哌唑片Aripiprazole Tablets/Abilify10mg片剂 Otsuka Pharmaceutical Co. Ltd 美国橙皮书 
    1-33阿立哌唑口崩片Aripiprazole Orally Disintegrating tablets/Abilify10mg片剂(口崩片)Otsuka Pharmaceutical Europe Ltd. 欧盟上市(产地:法国) 
    1-34盐酸环丙沙星片Ciprofloxacin  Hydrochloride    Tablets/Ciprobay0.25g(按C17H18FN3O3计)片剂 Bayer Vital GmbH原研进口 进口产品现名为环丙沙星片。
    1-35盐酸环丙沙星片Ciprofloxacin  Hydrochloride    Tablets/Ciprobay0.5g(按C17H18FN3O3计)片剂 Bayer Vital GmbH原研进口 进口产品现名为环丙沙星片。
    1-36盐酸特拉唑嗪片Terazosin Hydrochloride Tablets/Hytrin2mg(按C19H25N5O4计)片剂 Abbott Laboratories (Singapore) Private Limited原研进口  
    1-37吲达帕胺片Indapamide Tablets/Natrilix2.5mg片剂 Les Laboratoires Servier原研进口  
    1-38吲达帕胺缓释片Indapamide Sustained-release Tablets/Natrilix1.5mg片剂(缓释片)Les Laboratoires Servier原研进口  
    1-39左甲状腺素钠片Levothyroxine Sodium Tablets/Euthyrox50μg片剂 Merck Serono GmbH原研进口  
    1-40佐匹克隆片Zopiclone Tablets/Imovane7.5mg片剂 Sanofi-Aventis France原研进口  
    1-41佐匹克隆片Zopiclone Tablets/Imovane3.75mg片剂 Sanofi-Aventis France欧盟上市(产地:法国    ;上市国家:法国) 
    1-42硫唑嘌呤片Azathioprine Tablets/Imuran50mg片剂 Aspen Pharmacare Australia Pty Ltd原研进口 
    1-43奈韦拉平片Nevirapine Tablets/Viramune0.2g片剂 Boehringer Ingelheim Pharmaceuticals INC美国橙皮书 
    1-44米索前列醇片Misoprostol Tablets/Cytotec0.2mg片剂 Pharmacia Limited原研进口 
    1-45马来酸依那普利片Enalapril Maleate Tablets/Renitec5mg片剂 Merck Sharp & Dohme(Australia) Pty. Ltd.原研进口 
    1-46马来酸依那普利片Enalapril Maleate Tablets/Renitec10mg片剂 Merck Sharp & Dohme(Australia) Pty. Ltd.原研进口 
    1-47拉米夫定片Lamivudine Tablets/Epivir(3TC)0.15g片剂 ViiV Healthcare UK Limited原研进口 
    1-48拉米夫定片Lamivudine Tablets/Epivir(3TC)0.3g片剂 ViiV Healthcare UK Limited 原研进口 
    1-49拉米夫定片Lamivudine Tablets/Epivir-HBV0.1g片剂 GlaxoSmithKline美国橙皮书 
    1-50氯雷他定片Loratadine Tablets/Clarityne10mg片剂 Bayer SA-NV原研进口 
    1-51氯雷他定胶囊Loratadine Capsules/Claritin10mg胶囊剂 Bayer Healthcare LLC美国橙皮书 
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